The Effect of Cryotherapy on Recovery and Performance: A Randomized Controlled Double Blind Trial
Phase: NA
Conditions: Healthy
Sponsor: University of Applied Sciences and Arts of Southern Switzerland

University of Applied Sciences and Arts of Southern 
Switzerland 
 
 
 
SUPSI 
 
 
 
A randomized, controlled, double-blind study to investigate the 
effectiveness of cooling on performance and recovery 
 
Clinical Trial Protocol 
 
Short titel 
Effectiveness of cooling on recovery and performance 
Study Type: 
Clinical Observation-Study with a medical device Study 
Categorisation: 
Clinical 
Observation-Study 
the 
Category 
A 
after 
Swiss Ordinance on Clinical Trials in the 
Human research (ClinO: Art. 20) 
Study Registration: 
NCT02506283  
Study ldentifier: 
Sponsor, Sponsor-lnvestigator or 
University of Applied Sciences and Arts Southern Switzerland 
Principal lnvestigator: 
Physiotherapy Graubünden 
Weststrasse 8 
7302 Landquart 
Phone: +41 81 300 01 70 
 
Contact/ Director of 
Studies Dr. Clijsen Ron, 
PhD University of Applied 
Sciences Southern 
Switzerland Physiotherapy 
Graubünden 
Weststrasse 8, 7302 Landquart 
Phone: +41 81 300 01 75 
ron.clijsen@supsi.Ch 
 
lnvestigational Product: 
Zamar Therapy 
Certified 
Medical Device 
Medical Devices Act 
(ISO: 
93/42/EEC) 
 
after 
European 
13485:2012;  DIRECTIVE 
Protocol Version and Date: 
Protocol - Version 01 -13.02.2015 
\
Effect of cooling on recovery and performance -Version 01 -13.02.2015 
Page 1 of 57 
Originally in German, translated into English 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
SUPSI 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
Side 2 from 57 
 
 
 
 
CONFIDENTIALITY 
The information in this protocol is confidential and the property of the University of Applied Sciences 
Southern Switzerland, Physiotherapy Graubünden in Landquart-CH. The contents of this protocol should 
not be forwarded, reproduced, published or passed on to others - neither in full nor in parts - without the 
written consent of the head of the institute. Excluded from this are the statements in the subject 
information and the declaration of consent of the study participants. 
 
 
 
) 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
SUPSI 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
Side 3 from 57 
 
 
 
 
SIGNATURE OF THE PERSON RESPONSIBLE FOR THE STUDY 
 
 
Study number 
Study Title 
One Randomized, controlled double-blind study the 
Investigation of the effectiveness of cooling on recovery and 
performance 
 
 
 
 
Sponsor lnvestigator: 
) 
I confirm herewith the To carry out experiments,. how in the present protocol, version 01 of the 
13.02.2015,  and comply with the World Medical Association Declaration of Helsinki, ICH-GCP 
Guidelines, the ISO 14155 standard (where applicable), as well as the locally applicable Swiss Human 
Research Ordinance HFV 
 
Sponsor lnvestigator 
Dr. Clijsen Ron, PhD 
University of Applied Sciences 
and Arts Southern Switzerland 
Physiotherapy Graubünden 
Weststrasse 8, 7302 Landquart 
Phone: +41 81 300 01 75 
ron.clijsen@supsi.Ch 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Landquart, 13.02.2015 
 
 
Place/Date 
Signature 
 
 
 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
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SUPSI 
 TABLE OF CONTENTS 
 
STUDIES-SYNOPSIS ............................................................................................................................... 7 
OVERVIEW OF THE STUDY ................................................................................................................ 14 
STUDIES-SCHEDULE ............................................................................................................................ 16 
1. 
STUDIES-ADMINISTRATION ......................................................................................................... 17 
1.1 
Sponsor, Sponsor-lnvestigator ....................................................................................................... 17 
1.2 
Examiner..................................................................................., ....................................................... 17 
1.3 
Statistician ...................................................................................................................................... 18 
1.4 
Laboratory Manager ...................................................................................................................... 19 
1.5 
Monitoring the study ...................................................................................................................... 19 
1.6 
Privacy ........................................................................................................................................... 19 
) 
1.7 
Other committees or institutes involved ......................................................................................... 19 
2 
ETHICAL AND REGULATORY ASPECTS ..................................................................................... 20 
2.1 
Study Registration ......................................................................................................................... 20 
2.2 
Categorization of the study ............................................................................................................ 20 
2.3 Responsible ethics committee (Competent Ethics Committee: CEC) ........................................... 20 
2.4 Competent Authorities: CA) ........................................................................................................... 20 
2.5 
Ethical Leading the study .............................................................................................................. 20 
2.6 
Conflict of interests. ........................................................................................................................ 20 
2.7 
Patients-Information and Consent ................................................................................................. 20 
2.8 
Confidentiality & Privacy ................................................................................................................ 21 
2.9 
Early termination of the study ........................................................................................................ 21 
2.10 Protocol Adjustments .................................................................................................................... 21 
3 
BACKGROUND AND RATIONALE ................................................................................................. 22 
3.1 
Background and justification .......................................................................................................... 22 
3.2 
Medical product and indication ...................................................................................................... 23 
3.3 
Preclinical evidence ....................................................................................................................... 24 
3.4 
Current clinical evidence ............................................................................................................... 24 
3.5 
Medical product: method of application in the study ...................................................................... 25 
3.6 
Peers ............................................................................................................................................. 25 
3.7 
Risk/Benefits ................................................................................................................................. 25 
3.8 
Justification of the choice of population ......................................................................................... 27 
4 
STUDY OBJECTIVES ...................................................................................................................... 28 
4.1 
General objectives ......................................................................................................................... 28 
4.2 
Primary objectives ......................................................................................................................... 28 
4.3 
Secondary Objectives .................................................................................................................... 29 
4.4 
Other safety features-Aspects (Long-term) ................................................................................... 29 
5 
STUDIES OUTCOMES .................................................................................................................... 30 
5.1 
Primary outcomes ......................................................................................................................... 30 
5.2 
Secondary outcomes ..................................................................................................................... 30 
5.3 
Security Aspects ............................................................................................................................ 31 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
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6 
DESIGN STUDIES ........................................................................................................................... 32 
6.1 
Studies-Design and Justification .................................................................................................... 32 
6.2 
Method of minimization Influence .................................................................................................. 32 
6.2.1 Randomization ...................................................................................................................... 32 
6.2.2 Blinding ................................................................................................................................ 32 
6.2.3 More Methods ....................................................................................................................... 32 
6.3 
Procedure for the repeal of the Blinding (Codebreak) ................................................................... 32 
7 
STUDIES POPULATION ................................................................................................................. 33 
7.1 
Inclusion Criteria ........................................................................................................................... 33 
7.2 
Recruitment and screening ............................................................................................................ 33 
7.3 
Group assignment ........................................................................................................................ 34 
7.4 
Discontinuation of study participation ............................................................................................ 34 
8 
STUDY INTERVENTION ................................................................................................................. 35 
8.1 
Medicine Product 10 ...................................................................................................................... 35 
8.1.1 Intervention-Product ............................................................................................................. 35 
8.1.2 Packaging, Labeling and Usage ........................................................................................... 36 
8.1.3 Storage ................................................................................................................................. 36 
8.2 
Administration of the experiment ................................................................................................... 36 
8.2.1 Experimental Intervention ..................................................................................................... 36 
8.2.2 Control-Intervention ............................................................................................................... 36 
8.3 
Dose/ Device modifications .......................................................................................................... 36 
8.4 
Compliance with Study Intervention .............................................................................................. 36 
8.5 
Curing retired Participant. .............................................................................................................. 36 
8.6 
Preventive Measurements ............................................................................................................. 37 
8.7 
Accompaniments .......................................................................................................................... 37 
8.8 
Liability .......................................................................................................................................... 37 
8.9 
Return of the Medicine Product ..................................................................................................... 37 
9 
STUDY STRUCTURE & EVALUATION ......................................................................................... 38 
9.1 
Schedules of the Different Protocols .............................................................................................. 38 
9.2 
Measurement of outcomes ............................................................................................................ 39 
9.2.1 Measurement of primary outcomes ...................................................................................... 40 
9.2.3 Elevation Further Outcomes ................................................................................................. 40 
9.2.4 Collection of safety parameters ............................................................................................ 40 
9.2.5 Capture from Data in the event of early termination of studies ............................................ 42 
9.3 
Procedure for Each Visiting the test subjects ................................................................................ 43 
9.3.1 Single measurement ........................................................................................................... 43 
9.3.2 Multiple visits ........................................................................................................................ 43 
10 SAFETY ........................................................................................................................................... 45 
10.1 Drug Studies ................................................................................................................................. 45 
10.1.1 Definition and assessment of (serious) adverse events and other safety related events .... 45 
10.1.2 Reporting of serious adverse events (SAE) and other safety related events ....................... 45 
10.1.3 Follow up of (Serious) Adverse Events ................................................................................ 45 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
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SUPSI 
10.2 Medical Device Category C studies .............................................................................................. 45 
10.2.1 Definition and Assessment of (Serious) Adverse Events and other safety related events... 45 
10.2.2 Reporting of (Serious) Adverse Events and other safety related events .............................. 45 
10.2.3 Follow up of (Serious) Adverse Events ................................................................................ 45 
10.3 Medical Device Category A studies .............................................................................................. 45 
10.3.1 Definition and Assessment of safety related events ............................................................. 46 
10.3.2 Reporting of Safety Related Events ...................................................................................... 46 
11 STATISTICAL METHODS .............................................................................................................. 47 
11.1 Hypotheses & Factors ................................................................................................................... 47 
11.2 Sample Size .................................................................................................................................. 48 
11.3 Criteria for the statistical use the Data at Un olls Records ............................................................ 48 
11.4 Planned Analyses ......................................................................................................................... 48 
11.4.1 Datasets and Data Populations ............................................................................................ 48 
11.4.2 Primary Analysis ................................................................................................................... 48 
11.4.3 Secondary Analysis .............................................................................................................. 49 
11.4.4 Innterims analyses ................................................................................................................ 49 
11.4.5 Security analyses .................................................................................................................. 49 
11.4.6 Deviations ............................................................................................................................ 49 
11.5 Drop-outs and missing data .......................................................................................................... 49 
12 QUALITY ASSURANCE AND CONTROL ..................................................................................... 50 
12.1 Data Archiving ............................................................................................................................... 50 
12.1.1 Forms .................................................................................................................................... 50 
12.1.2 Specification from Forms ...................................................................................................... 50 
12.1.3 Archiving of the data ............................................................................................................. 50 
12.2 Data management ....................................................................................................................... 50 
12.2.1 Data Management System ................................................................................................... 50 
12.2.2 Data integrity and Backup ..................................................................................................... 50 
12.2.3 Analysis and Archiving .......................................................................................................... 50 
12.2.4 Validation of electronic data ................................................................................................. 51 
12.3 Monitoring ...................................................................................................................................... 51 
12.4 Audits and Inspections .................................................................................................................. 51 
12.5 Confidentiality and data protection ................................................................................................ 51 
12.6 Storage of biological material and Related health data ................................................................ 51 
13 PUBLICATION AND DISCLOSURE OF DATA ............................................................................. 52 
14 FINANCING AND AND SUPPORT ................................................................................................ 53 
14.1 Financing ...................................................................................................................................... 53 
14.2 Further Support ............................................................................................................................. 53 
15 INSURANCE ................................................................................................................................... 53 
16 REFERENCES .............................................................................................................................. 54 
17 APPENDIX ...................................................................................................................................... 57 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
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SUPSI 
Study Synopsis 
(ClinO, Appendix 3, 1.1, 2.1, 3.1, 4.1; Appendix 5, 2b; AGEK Summary) 
 
 
 
 
 
 
 
 
 
 
 
 
Sponsor 
I 
Sponsor 
lnvestigator 
University of Applied Sciences and Arts Southern Switzerland 
Department of Business Economics, Health and Social Care 
Physiotherapy Graubünden 
e.g.H. Dr. Ron Clijsen 
Weststrasse 8 
CH-7302 Landquart 
Study Title: 
A randomized, controlled, double-blind study to investigate the 
effectiveness of cooling on  performance and recovery 
Short Title / Study 
10: 
 
Effectiveness of cooling on  recovery and performance 
Protocol Version 
and Date: 
 
Version 01 from 13.02.2015 
 
Trial registration: 
Cantonal Ethics Committee Zurich 
 
Study Category 
and Rationale: 
 
Observational study Cat. A according to the Lesson Ordinance (Art. 20) 
The test subjects are not given  medication or tissue samples are taken.  
No invasive methods  are used. 
Clinical Phase: 
- 
 
 
 
 
Background and 
Rationale: 
External cooling applications have been known in elite sports for years and are 
already being used there. This non-invasive intervention is also gaining popularity 
in popular and amateur sports. 
Cooling is  said to have positive effects before and after sporting activity. For 
example, cooling after sporting activity  is said to contribute to improved 
regeneration, 
while 
 
pre-activity 
cooling 
is 
supposed 
to 
increase 
performance.Literature on post- and pre-activity cooling is already available. 
However, the results are  inconclusive and more randomized controlled trials  
need to be conducted to clarify the results.  

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
Side 8 from 
 
 
 
 
SUPSI 
 
 
 
 
 
 
 
 
 
 
 
Objective(s): 
This study will investigate the effectiveness of cooling and provide new insights 
into the sensible use of this form of application. 
 
The study is divided into different sub-projects: 
 
A- Effect of post-activity cooling on vertical jump height and assessment of 
subjective muscle soreness in the legs and perceived general fatigue during 72 
hours of recovery time. As an exhaustive measure, the subjects must complete 
maximum vertical jumps for 1 min. 
 
B- Effect of preactivity cooling on maximum voluntary isometric muscle 
contraction of the thigh muscles and the assessment of subjective muscle 
soreness in the legs and perceived general fatigue during 72 hours of recovery 
time. As an exhaustive measure, subjects must isometrically contract and relax 
their ventral thigh muscles to 60% of their maximum voluntary ventral thigh 
contraction capacity for 1 min. 
 
 
 
 
 
 
 
 
 
Outcome(s): 
 
Primary OutComes 
 
Recovery parameters and performance parameters 
 
- 
Jump height (cm) 
 
- 
Subjective muscle soreness in the legs (VAS scale 0 -10) 
 
- 
Subjective information on general exhaustion (BORG scale 0 - 10) 
 
Maximum voluntary isometric muscle contraction of the thigh muscle 
(mV) 
 
Secondary Outcome 
 
None 
Study design: 
Randomized, controlled, double-blind study 

University of Applied Sciences and Arts of Southern Switzerland, 
Department of Business Economics. Health and Social Care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
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SUPSI 
 
Inclusion / 
Exclusion criteria: 
Inclusion Criteria 
Young, healthy adults aged  18 - 30 years 
No surgical interventions on the musculoskeletal system in the trunk 
area and lower extremities 
Injuries to the trunk and/or lower extremities that occurred more than 
11 years ago and no longer cause symptoms 
• 
Anti-conception drugs 
 
 
Exclusion criteria 
Current injuries of any kind affecting the trunk and/or  lower extremities 
Injuries to the torso and/or lower extremities   that occurred less than 1 
year  ago 
Injuries to the trunk and/or lower extremities that occurred more than 1 
year  ago and are still causing symptoms 
Fear of cooling intervention 
Taking medication of any kind (even self-purchased ) 
Pacemakers & cardiac arrhythmias Known 
circulatory problems Pregnancy 
Diagnosed skeletal static deviations 
appendectomy less  than 2 years ago. Raynaud's 
syndrome 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
Side 10 from 
 
 
 
 
SUPSI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Jump height measurement 
 
The jump height after the load is determined with a jump height measuring plate 
designed for this purpose (Just Jump Plate, Probotics lnc., Huntsville, USA). The 
test subjects assume a standing position on the plate. The test subjects are 
allowed to start from the squatting position (countermovement jump) to measure 
the jump height. The arms must be placed at the hips during the entire movement. 
The jump height is measured in cm and takes place directly, 24 hours, 48 hours 
and 72 hours after the interventions. 
 
Subjective muscle soreness 
 
The subjects reported their subjective feeling of muscle soreness on a visual 
analogue scale (VAS). The scale will be scaled from "0" (no muscle soreness 
present) to "10" (largest imaginable muscle soreness) in cm increments. The 
measurement takes place directly, 24 hours, 48 hours and 72 hours after the 
interventions. 
 
Subjective information on general exhaustion 
 
The subjects reported their subjective general feeling of exhaustion on a BORG 
scale (0 - 10). The scale will be scaled from "0" (no general exhaustion) to "10" 
(greatest conceivable general exhaustion) in cm increments. The measurement 
takes place directly, 24 hours, 48 hours and 72 hours after the interventions. 
Measurements 
and procedures: 
Measurement 
the 
Maximum 
Arbitrary 
Isometric 
thigh/muscle contraction (MV/C) 
Muscle activity is monitored with the help of the wireless surface electromyogram 
system 
sEMG 
active 
sensors 
from 
PLUXwireless 
bodysignals 
S.A. 
(physioplux.com), bandpass filtered between 25- 500Hz and full-wave rectify. 
MVIC is measured on the Cor 1 - ergometer chair in 90° knee flexion. 
 
The raw data of muscle activity is processed with the software of 
PLUXwireless biosignals S.A. 
 
The electrodes are placed according to the internationally recognized SENIAM 
guidelines (SENIAM project 2013). 
 
Further processing of the data 
 
MATLAB® will be used for further data analysis, and Excel from Windows® will 
be used for data pooling and for the graphical representation of the end data. 
 
Determination of 60 % of MV/C 
 
60% of MVIC is performed on the Cor 1 - ergometer chair for biomechanical 
measurements V1.0 (www.otbioelettronica.(it). 
 
All measurements related to MVIC are measured in the Cor 1 in a squat position 
of 90°. 

University of Applied Sciences and Arts of Southern Switzerland 
Department of BusinessEconomics. Health and Social Care 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
Side 11 from 57 
 
 
 
 
SUPSI 
 
 
ZAMAR Therapy 
 
Zamar Therapy is a certified medical device according to European 
 
Directives (Directive 93/42/EEC and ISO 13485:2012). The temperature can be 
Study Product  / 
Intervention: 
for this device from -5.0 °C to +45 °C. The maximum 
adjustable treatment time is 1 hour. Ensure cuffs 
the 
Optimal 
Contact with the 
corresponding 
Localization. 
One 
 
Coolant circulates 
continuously between 
the device and the 
 
Cuff. 
 
In this study, temperatures of + 8 °C (cooling) and thermoneutral temperatures 
( + 32 °C) are used for 20 minutes. 
 
 
In order to obtain high-quality stemresults, the 
Control 
Intervention (if 
applicable): 
subjects were exposed to only one experimental condition at a time. Two 
experimental conditions (cooling vs. thermoneutral application) are compared. 
This applies both to subproject Aals on subproject 8. 
 
The division into the 2 possible groups is randomized. The data collected in this 
way is processedby outcome or group pooled. 
 
 
For financial reasons  , the number of subjects is limited to a total of 40 
participants. 
 
The planned number of 20 subjects (ProjectA ), or  20 
Number of 
Participants with 
Rationale: 
Subjects (Project B) also correspond to the group sizes of the 
comparable Kühl1 studies (cf. (Ascensao et al. 2011, Bailey et al. 2007, 
Crystal et al. 2013, Rowsell et al. 2009, De Pauw et al. 2014, Guilhem et 
al. 2013, Jakeman et al. 2009, Howatson et al. 2009, 
 
Montgomery et al. 2008, Rupp et al. 2012, Yanagisawa et al. 2003, 
 
u.a.). 
 
Study Duration: 
April 2015 - February 2016 
 
Study Schedule: 
April 2015: planned start of measurements  
February 2016: End of measurements 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
Side 12 from 57 
 
 
 
 
SUPSI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator(s): 
 
Examiner 
- Dr. Ron Clijsen1•2•3 
- Prof. Dr.  Jean-Pierre Baeyens1•3•4 
- Prof. Dr. Peter Clarys3 
- Dr. Ursula M. Küng1 
- Hohenauer Erich, MSc1•2 
 
 
1Uuiversily College Physiolherapy 11,im 11an der Laan, Weslstrasse 8, 7302 Landquar/ 
1 Fachhochsc/111/e Siidschweiz, Departement of Business Eco110111ics, Heafthand Sociaf Care, Physiolherapie 
Gra11bü11de11, Weststrasse 8, 7302 Landuart 
3 Vrije Universileit Bmssels, Facufty of Physical Ed11Cf1tion and Physical 111erapy, Plei11/a1111 2, 1050 
Brusse/s 
' University of A11twe1p, Faculty of Appsong E11gi11eeri11g, Prinsslraat 13, 2000 A111we1p 
 
 
 
 
Contact/ Director of Studies 
Dr. Clijsen Ron, PhD University of 
Applied Sciences Southern 
Switzerland Physiotherapy 
Graubünden Weststrasse 8, 7302 
Landquart 
+41813000175 
ron.clijsen@supsi.anyway 
 
 
 
Study Centre(s): 
Single Centre Study: 
Thim van der Laan University College Physiotherapy 
Weststrasse 8 
7302 Landquart 

University of Apptied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
Side 13 from 
 
 
 
 
SUPSI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical 
Considerations: 
The effectiveness of cooling on recovery and performance are tested on: 
 
Repeated measures analysis of variance (MANOVA) factors: 
Protocol A 
 
- 
Task (Cooling vs. Thermoneutral application) 
 
- 
Time (These factors are  measured immediately after cooling 
and 24 hours, 48 hours and 72 hours after the interventions) 
 
 
 
Protocol B 
 
Task (cooling vs. thermoneutral application) 
 
Time (These factors are measured immediately after cooling 
and 24 hours, 48 hours and 72 hours after the interventions ) 
 
 
 
The significance level is P < 0.05,  the statistical data analysis is carried out with 
SPSS 22. 
GCP Statement: 
This study will be conducted in compliance with the protocol presented here, the 
current version of the Declaration of Helsinki, the ICH-GCP, ISO EN 14155 (as 
far as authoritative), and the Swiss Human Research Ordinance HFV. 

University of Applied Sciences and Arts or Southern 
Switzerland 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
Side 14 from 57 
 
 
 
 
SUPSI 
 
 
Overview of the study 
 
Cold therapy, such as cold water immersions and ice packs, has long been known as post-activity 
recovery strategies. Sports with different levels  of intensity lead to different levels of exhaustion of the 
body's musculoskeletal, neuronal and metabolic systems. Exercise can also lead to microscopic injuries 
in muscle tissue, colloquially known as muscle soreness. In sports physiotherapy and rehabilitation, cold 
therapy has long been used as a post-activity intervention to alleviate these subjective symptoms. This 
is also confirmed by the current scientific knowledge base (Ascensao et al. 2011, Banfi et al. 2010, Crystal 
et al. 2013, Delextrat et al. 2013, u.a.). Cold therapy is usually referred to as a procedure 
  which aims to alleviate pain symptoms and inflammatory processes. 
 
This mechanism is attributed to the vasoconstrictive effect of cooling, which affects the 
Inflammatory response reduced by decreased cell metabolism (White et al. 2013). A recovery period that 
is too short or not rewarding can result in an athlete not being able to complete their training at the required 
intensity. Furthermore, a complete recovery is important in order to achieve optimal competition 
performance. A recently published meta-analysis by Leeder et al. (2012) was able to show that cold water 
immersions are an effective strategy to reduce muscle soreness symptoms after exhausting and 
strenuous physical exercise. These results are in line with those of Bleakley et al. (2012), who were able 
to show in their meta-analysis that cold applications reduce subjective stress sensations by up to 
72 hours after cold application compared to passive interventions. However, cold applications are not 
only used to positively influence recovery times, but are also used.a. used in elite sports to increase the 
performance of athletes. The authors, who have already dealt with these topics in the literature, clearly 
point out the importance of  publishing further study results on these topics in order to confirm or refute 
the results known so far. Looking at the methodological quality of the individual studies, it also becomes 
clear how important it is to deliver high-quality study results in this area. 
 
The question now arises as to whether cooling with the Zamar Therapy device can have a positive effect 
on performance or the subjective feeling of recovery. 
 
Aim of the study 
In this study, the effect of a 20-minute cooling application (+8 °C) on the subjective muscle soreness and 
general fatigue data, as well as the objectively measurable, maximum isometric muscle contractions of 
the ventral thigh muscles and the jump height after strenuous physical exertion will be investigated. The 
effects of cooling are compared to a thermoneutral application (+32 °C} and compared over 72 hours 
(immediately after, 24 hours, 48 hours and 72 hours after the interventions). The aim is to make 
recommendations for cooling applications in the field of recreation and performance and to substantiate 
the state of scientific knowledge. This study can benefit all those who work with amateur and elite athletes. 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
Side 15 from 57 
 
 
 
 
SUPSI 
Abbreviations 
 
 
CA 
CEC 
Competent Authority (e.g. Swissmedic) 
Competent Ethics Committee 
 
 
 
 

University of Applied Sclences and Arts or Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of cooling on recovery and performance - Vell'sion 01 - 13.02.2015 
Side 16 from 57 
 
 
 
 
SUPSI 
 
 
Study Schedule 
(AGEK 4.2; SPIRIT #13; I IT 6.4.2) 
The completion of the measurement series is planned for December 2015, and the completion of the 
entire project for December 2016. 
Table 1: Schedule 
 
 
 
 
 
 
Aug 
 
'15 
Data collection 
Subproject A 
 
Data Collection 
Subproject B 
Statistics Subproject A 
Writing the article 
Subproject A 
Statistics Subproject B 
Writing the article 
 
 
 
 
 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Econornics, Health and Social care 
Effect of cooling on recovery and performance - Version 01 - 13.02.2015 
Side 17 from 57 
 
 
 
 
SUPSI 
 
 
1. 
STUDY ADMINISTRATION 
 
1.1 
Sponsor, sponsor lnvestigator 
 
 
University of Applied Sciences and Arts Southern Switzerland 
Department of Business Economics, Health and Social Care 
Physiotherapy Graubünden 
 
Dr. Ron Clijsen, PhD 
Weststrasse 8 
7302 Landquart 
 
+41 81 300 01 75 
ron.clijsen@supsi.ch 
 
1.2 
Examiner 
 
Director of Studies 
Dr. Ron Clijsen1•2•3 (PhD, GCP Module 1- III & GCP Basic Course) 
Selection of subjects, obtaining consent to participate in the study, study administration, carrying out the measurements - 
collecting the data, analyzing the data, interpreting the data, writing the report 
University of Applied Sciences and Arts Southern 
Switzerland Research Manager University of Applied 
Sciences and Arts Southern Switzerland Weststrasse 8, 
7302 Landquart 
+41 81 300 01 73 
ron.clijsen@supsi.ch 

University of Applied Sciences and Arts of Southern Switzerland 
Department of Business Economics, Health and Social Care 
Effect of Cooling on Recovery and Performance - Version 01 - 13.02.2015 
Side 18 from 57 
 
 
 
 
SUPSI 
Other examiners 
Prof. Dr. Jean-Pierre Baeyens2•3.4 
Data analysis, interpretation of the data 
Prof. Dr. Peter Clarys 3 
Study Monitoring/Monitoring 
Dr. Ursula M. Küng2 (PhD, GCP Module 1- III & GCP Basic Course) 
Selection of test subjects, data analysis, interpretation of the data, writing of the report 
Hohenauer Erich1'2, MSc (MSc, GCP Module I - III & GCP Basic Course) 
Selection of the subjects, execution of the measurements - collection of the data, data analysis, interpretation of the data, 
writing of the report, obtaining consent to study participation, study administration 
 
1 University of Applied Sciences and Arts Southern Switzerland, Department of Business Economics, Health 
and Social Gare, Physiotherapy Graubünden, Weststrasse 8, 7302 Landquart 
2 University College Physiotherapy Thim van der Laan, Weststrasse 8, 7302 Landquart 
3 Vrije Universiteit Brussels, Faculty of Physical Therapy, Pleinlaan 2, 1050 Brussels 
4 University of Antwerp, Faculty of Applied Engineering, Printstraat 13, 2000 Antwerp 
 
 
Other employees 
none 
 
 
1.3 
Statistician 
 
Prof. Dr. Jean-Pierre Baeyens 
Vrije Universiteit Brussels 
Faculty of Physical Education and Physical Therapy 
Pleinlann 2 
1050 Brussels 
+32-2-6292722 
 
University of Antwerp 
Faculty of Applied Engineering 
Printstraat 13 
2000 Antwerp 
+32-3-265-41-11 
 
jean-pierre.baeyens@vub.ac.mal 

University of Applied Sciences and Arts of Southern Switzerland 
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1.4 
Laboratory Manager 
 
Dr. Ron Clijsen, PhD 
Head of Research 
Laboratory 
University of Applied Sciences Southern Switzerland, Department of Business Economics, Health and 
Social Care Physiotherapy Graubünden 
 
Weststrasse 8 
7302 Landquart 
+41813000175 
ron.clijsen@supsi.Ch 
 
 
1.5 
Monitoring the study 
Prof. Dr. Peter Clarys 
 
Vrije Universiteit Brussels 
Faculty of Physical Therapy 
Pleinlaan 2, 1050 Brussels 
 
Peter.clarys@vub.ac.mal 
 
 
1.6 
Privacy 
All data obtained from study participants will be coded and not passed on to other people. Personal data 
and personal details are stored in paper form in a locked filing cabinet. Only the study supervisor, the 
head of the research laboratory and the study director at the same time have access here, with the 
management of the documents being the responsibility of the head of the research laboratory. 
All digital data is anonymized and encoded. No conclusions can be drawn about individuals. The digital 
data is stored and archived on in.stituts' internal computers and is not released to outsiders. 
Employees involved in data processing have no insight into the personal data and the coding of it. 
 
1.7 
Other committees or institutes involved 
 
The study is being conducted in the research laboratory at the University College Physiotherapy Thim 
van der Laan, Weststrasse 8, CH-7302 Landquart. 
The test products and measuring equipment are all located in this room and therefore all measurements 
and training can be carried out at the same location. The room offers enough space to be able to comply 
with all the safety aspects described below without any problems. 
At present, no further studies with this arrangement are taking place in this experimental laboratory. 
Currently, another study is taking place in our institute (KEK-ZN-Nr.2014-0107 to investigate the 
effectiveness of slackline training). However, the measurements of these two studies do not take place 
at the same time and do not hinder or influence each other. Thus, the utilization of the infrastructure is 
not excessive and is justifiable. 

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There are no other institutes or committees involved in this study. approval or monitoring of the study. 
 
 
2 
ETHICAL AND REGULATORY ASPECTS 
2.1 
Study Registration 
The implementation of the present study is the responsibility of the Zurich Cantonal Ethics Committee. 
An  application for admission is submitted. Any further conditions of the responsible ethics committee 
must be implemented in the study protocol. 
When  the study protocol is submitted to the Cantonal Ethics Committee  in Zurich, the study is also 
registered with the Swiss Coordination Office for Research on Human Subjects. 
 
2.2 
Categorization of the study 
 
Observational study Cat. A (ClinV Art. 20) 
The test subjects are not given medication or tissue samples are taken. No invasive methods are used. 
Trials  are carried out with CE-certified medical devices in accordance with their instructions for use. 
 
2.3 
Competent   IEthics Committee (CEC) 
Human research in the Canton of Graubünden falls under the remit of the Cantonal Ethics Commission 
Zurich. Changes to the study protocol are not permitted without the prior consent of the CEC, except for 
the immediate elimination of obvious hazards to the participants. These are according to Chapter 2.10 of 
the CEC. 
An early termination or interruption of the study must be reported to the CEC within 15 days, and 
the regular end within 90 days. The final report must be submitted within one year of the end of the 
programme. Corrections are in accordance with Chapter 2.1O. 
 
2.4 
Competent Authorities (  CA) 
The present study falls under the remit of the Zurich Cantonal Ethics Committee. Obligations and 
deadlines can be found in the previous point. 
 
2.5 
Ethical Leadership of the Study 
The study will be conducted in accordance with this protocol and the current version of the Helsinki 
Declaration, the ICH-GCP, the European Medical Devices  Directive 93/42/EEC and the ISO standard 
14155 and ISO 14971 (where applicable), as well as the Swiss Human Research Ordinance and thus 
Swiss law. 
The CEC receives an annual report and is informed about the course of studies. 
 
2.6 
Conflict of interests 
There is no conflict of interest of a financial nature on the part of the sponsor investor (head of studies), 
nor is there a corresponding relationship of dependency. 
 
2.7 
Patient information and informed consent 
The examiners will explain to each participant the nature and goal of the study. This also includes the 
expiration of the protocol, the approximate duration, possible risks and benefits. The participant is 
informed that participation is voluntary and can be withdrawn from the study at any time without further 
personal consequences of any kind. The participant is further informed  about who has access to the 
personal data and how data protection is guaranteed. 
Each participant receives written information about the test subject and the declaration of consent with 

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the description of the study with all the information necessary  to decide whether to participate in the 
study. He or she will also be given sufficient time to read this written information and to ask questions to 
the responsible examiner. 
The subject information and the informed consent form are submitted to the CEC,  where it must be 
reviewed and approved. 
The signed declaration of consent must  be submitted before the start of the study procedure. The 
participant should read and check them before signing.  The responsible  examiner then also signs the 
declaration of consent. Finally, the participant receives a copy of the declaration of consent. The signed 
declaration of consent is kept in the original as a study document in a locked filing cabinet. 
 
2.8 
Confidentiality & Privacy 
The examiners ensure that the privacy of the participant is maintained. In particular, data protection and 
confidentiality are  guaranteed and  no personal data is presented or published. The signed declaration 
of consent, as well as the completed questionnaire with the other personal details, are kept in the original 
as a study document in a locked filing cabinet. 
The digital data will be anonymized and treated confidentially, and access to the personal data will not 
be allowed to third parties. The digital data collected is stored solely on the institute's own computers and 
is not passed on  to any external persons or transferred to other computers. 
 
Direct access to the personal data is only  available to the head of the research laboratories (study leader), 
the study supervisor and authorized persons of the CEC. 
 
 
2.9 
Early termination of the study 
The sponsor investor (principal investigator) may discontinue the study early if/if ethical 
concerns arise 
insufficient number of subjects 
the safety of the participants cannot be  guaranteed 
 
Findings from clinical practice a continuation the Making the study pointless 
early evidence or harm of the experimental intervention has been proven 
 
 
2.10 Protocol Adjustments 
Adjustments and changes to the current study are only permissible after review by the CEC. 
Short-term changes  to the protocol prior to an audit by  the CEC may be made to ensure the rights and  
safety of participants. However, such adjustments must be documented and reported to the CEC  as 
soon as  possible. 
Extensive adjustments are only  permissible after a review by the CEC. Small adjustments must be 
notified to the CEC as soon as possible and listed in the annual report. 

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3 
BACKGROUND AND RATIONALE 
 
3.1 
Background and justification 
 
 
 
Cold therapies have long been used as a treatment after strenuous exertion (Costello et al. 2012). In 
sports medicine, cold therapy is a common intervention, the effect of which has already been investigated 
in many studies. Cold therapy applications are used to alleviate the symptoms of subjective muscle 
soreness and general fatigue (Ascensao et al. 2011, Bailey et al. 2007, Costello et al. 2012, Crystal et al. 
2013, Delextrat et al. 2013, Elias et al. 2012, Eston et al. 1999, Goodall et al. 2008, Guilhem et al. 2013, 
Hausswirth et al. 2011, Howatson et al. 2009, lngram et al. 2009, Jakeman et al. 2011, King et al. 2009, 
Kuligowski et al. 1998, Minett et al. 2012, Paddon-Jones et al. 1997, Pointon et al. 2011, Pointon et al. 
2012, Pournot et al. 2011, Rowsell et al. 2009, Rupp et al. 2012, Sellwood et al. 2007, Stanley et al. 2013, 
Tseng et al. 2013) . Furthermore, cold therapy is used to determine objective parameters, e.g.creatine 
kinase, lactate, various interleukins or C-reactive proteins (Crowe et al. 2007, Leal et al. 2011, Tucker et 
al. 2012, Pointon et al. 2012, Vaile et al. 2088, Heyman et al. 2009, Bastos et al. 2012, De Pauw et al. 
2014, King et al. 2009, Howatson et al. 2009, Guilhem et al. 2013). However, cryotherapy is not only used 
to optimize subjective and objective recovery parameters, but also to improve objective performance 
(Duffield et al. 2009, Boegard et al. 2010, Brade et al. 2014, Wegmann et al. 2012). Cold therapy is 
described as a procedure that relieves pain and specifically reduces inflammatory reactions after injuries 
and overuse. As a mechanism of action of cooling, it is said to have the vasoconstrictive effect, which 
reduces inflammatory reactions by reducing cell metabolism. Banfi et al. (2010) recently published results 
according to which whole-body cooling would not have a negative effect on athletes. However, only little 
evidence could be found here that favored whole-body cooling over "non-cooling". Leeder et al. (2012), 
on the other hand, was able to show that cold water immersions are an effective strategy to alleviate 
subjective symptoms. These results are consistent with those of Bleakly et al. (2012). Wegmann et al. 
(2012) 
 
were able to show in their meta-analysis, that Prrä activity cooling effectively has a positive effect on the 
endurance capacity. The application of external refrigeration applications was preferred to internal 
refrigeration applications in terms of the potential performance-enhancing effect. 
 
Aim of the studies 
In this study, the effect of a 20-minute cooling application (+8 °C) on the subjective muscle soreness 
and general exhaustioninformation, as well as the objectively measurable maximum isometric muscle 
contractions of the thigh muscle and the jump height after strenuous bodyStresses and strains are 
examined. 
The effects of 
cooling are compared with a thermoneutral application (+32 °C) and applied directly, 24 hours, 48 hours 
and 72 hours after the interventions. The aim is to, To make recommendations for cooling applications 
in the field of recovery and performance and to substantiate the state of scientific knowledge. This 
Studie is thus intended to provide trainers, therapists and provide doctors with in-depth insights. 

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The study is  divided into two sub-projects: 
Post-activity cooling (subproject A) - In this subproject, the influence of post-activity cooling compared 
to thermoneutral application on recovery is determined. It is  investigated whether the maximum jump 
height changes between these interventions after maximum performance in the form of vertical jumps 
(1 min) and 20 min of sustained cooling or thermoneutral application  (direct, 24 hours, 48 hours, 72 
hours after the interventions). To investigate this, the test subjects are tested before the maximum 
performance (1 min vertical jumps) and again directly, 24 hours, 48 hours and 72 hours after 
cooling/thermoneutral application. In order to be able to determine the baseline  and measure the 
effect of cooling compared to  the thermoneutral application  , the test subjects must each perform 3 
vertical, maximum jumps. The maximum vertical jump height is  used as an objective recovery factor 
in this subproject. Weilers,  this subproject investigates  the extent to which the subjective muscle 
soreness and general exhaustion data of the test subjects differ within the cooling group and 
thermoneutral 
 
group. To this end, before and inach the maximum performance (1 min vertical jumps) measured 
the subjective information of the test subjects (direct, 24 hours, 48 
hours, 72 hours after cooling/thermoneutral application). A 0 - 10 VAS and 0 - 10 BORG scale is 
used. The VAS and BORG data are  used as a subjective recovery factor in this subproject. 
 
 
Preactivity cooling (subproject B) - In this subproject, the influence of preactivity cooling compared to 
thermoneutral application on performance  is determined. It is  investigated whether the MVIC of the 
ventral thigh muscle changes between these interventions after submaximal performance in the form 
of 60% MVIC (1 min) of the ventral thigh muscle and preceding 20 min of cooling or thermoneutral 
application. In order to determine the baseline and to investigate the effect of cooling on the MVIC, 
MVIC is  determined via an EMG measurement and on the Cor 1 before loading. Following the MVIC 
determination, 60% of the MVIC  is determined. Afterwards  , the subjects will perform a submaximal 
isometric contraction (60% MVIC) for 1 min. Before this submaximal load, the test subjects receive 
cooling or a thermoneutral application. Following the submaximal load and 24 hours, 48 hours and 72 
hours after the load, MVIC is tested again. MVIC will be   
subproject as objective performance factors. Furthermore, this study examines the subjective 
 
Muscle soreness as well as the general state of exhaustion before and after cooling (directly, 
24 hours, 48 hours, 72 hours after the interventions). This is done with a 0-10 VAS and a 0-10 BORG 
scale. The VAS and BORG data are used as subjective performance factors in this subproject  . 
 
 
3.2 
Medical product and indication 
 
Zamar Therapy 
Zamar Therapy is a certified medical device according to European directives (Directive 93/42/EEC 
and ISO 13485:2012). The temperature can be reduced from -5.0 °C to +45 °C. The maximum 
adjustable treatment time is 1 hour. Cuffs ensure optimal contact with the corresponding body 
region. A coolant circulates continuously between the device and the cuff. 
This device is used for the following indications: treatment of the musculoskeletal system (contusions, 
contractures, grade III lesions, hematomas), tendinogenic system (tendinitis, tenosynovitis, 
tendinopathy), bone-cartilage system (contusions, post-mortem lesions) fractures), capsuloligamentary 
system (sprains, contusions of ligaments), postoperative, aesthetic surgery and to accelerate recovery 
time. 

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In this study, temperatures of + 8 °C and thermoneutral temperatures ( + 32 °C) are used for 20 
minutes . 
 
 
 
Fig. 1: Zamar Therapy (www.zamarmedical.com) 
 
 
 
  There is no written agreement with Zamar Medical to provide the Zamar Therapy for this study.   
 
 
3.3 
Preclinical evidence 
(ICH/E6 6.2.2; SPIRIT #Ga) 
ICH: A summary of findings from clinical studies that potentially have clinical significance ..... 
Various studies have already shown that cooling has been able to achieve a positive influence on 
performance  and recovery capacity compared to non-cooling measures . These positive effects could 
be observed both on a subjective level (Ascensao, 2011; Bailey, 2007; Minett, 2012; lngram, 2009, 
Delextrat, 2013; Elias, 2012), as well as on an objective level (Tseng, 2013; Pournot, 
2011; Ascensao, 2011; Pointen, 2011; Tucker, 2012, Heyman, 2009). On the other hand, there are 
studies that question the effectiveness of cooling in terms of its effectiveness (Leal, 2011; Hassan, 2011; 
Jakeman, 2011) 
 
3.4 
Current clinical evidence 
(ICH/E6 6.2.2; SPIRIT #6a) 
ICH: A summary of findings from ... and from clinical trials that are relevant to the trial. 
Current research results regarding the cooling effects, on which the partial protocols of this study are 
based, have been presented in chap. 3.3. 
Castle et al. (2005) were already able to observe a significantly increased peak power output after the 
application of cold packs to the thigh muscles compared to passive interventions (p<0).05). A systematic 
review by Ross et al. (2013)  also showed that  most studies  were able to show a success of cooling on 
performance. Similar results can be observed with regard to cooling and recovery (Ascensao et al. 2011, 
Bailey et al. 2007, Costello et al. 2012, u.ä.). 
The main problem with this type of results is that there is a lack of high-quality studies that include blinding   
subjects and examiners. Only these types of studies will be able to explain the actual effect of cooling as 
the number of studies increases. Broatch et al. (2014) already point to this problem. They discuss whether 
the effect of cooling actually takes place on a physiological or more on a psychological level. 

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Currently, there is no research taking place in the research laboratory of the Thim van der Laan University 
College Physiotherapy with the product Zamar Therapy or any other device from Zamar Medical. 
According to information and knowledge of Zamar Medical (Porec, Croatia), no further research is currently 
taking place with Zamar Therapy. 
 
3.5 
Medical product: Type of use in the study (ICH/EG6.2.4; 
SPIRIT #Ga) 
ICH: Description of and justification for the route of administration, dosage, dosage regimen, 
and treatment period(s). 
 
Zamar Therapy from Zamar Medical is used in this study. This thermotherapy device is used as part of 
the intended application. The examiners apply cold or thermoneutral temperatures. The applied 
temperatures do not pose a danger to the test subjects at any time. The Zamar Therapy can be used 
for a maximum of one hour and can generate temperatures from - 5°C to + 45°C. In this study, we will 
use temperatures of +8 °C (cold application) and + 32°C (thermoneutral application) in subproject A 
and subproject B. Doctors and physiotherapists can opt in their treatment for cold treatments to 
e.g.B. pain relief. However, these professional groups not only work with patients, but also with 
hobbyists and top athletes, or provide them with individual care. The question of whether the recovery 
phase can be shortened, or the performance can be increased by means of cooling applications is a 
legitimate question. These two parameters include not only objective values but also subjective 
information from the athlete. 
 
3.6 
Comparison group 
(AGEK 11.3; SPIRIT #6b) 
 
Cooling vs. Thermoneutral application 
 
Two groups are compared to each other  in order to compare the effects of cooling compared to 
thermoneutral application. In this way, the efficiency of cooling should be reduced to the ability to recover 
or performance. The cooling temperature within the cooling group will be +8 °C for both the recovery and 
performance tests  . The temperature of the thermoneutral application will be  + 32 °C for both the 
recovery and performance tests. 
 
Randomization 
 
In order to produce a high-quality study, the test subjects are each assigned to an experimental group, 
which are later compared with each other. 
The classification is carried out randomly, and the data collected in this way are pooled accordingly 
according to application. 
 
 
3.7 
Risk/ Benefits 
(ClinV, Appendix 4, 3.5; Type 25d2; ICH/EG6.2.3; AGEK 11.1; SPIRIT #Ga; MD: ISO 14155 Annex A 
& 150 14971) 
ICH: Summary of the known and potential risks and benefits, if any, to human subjects. 
For the subjects, there is a minimal risk of overload during the maximum jumping exercise for 1 min and 
the MVIC 60% of the ventral thigh muscles (1 min). The rehearsals are expressly informed that they have 
reached the maximum or submaximal load at any time. Furthermore, 2 examiners will be next to the 
subject during the 1 min jump load to support him/her in case of circulatory problems 

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to be able to absorb it. A fully equipped emergency kit is in the examination room at all times during the 
examinations. In the case of circulatory problems due to hypoglycaemia, the examination room also 
includes dextrose, chocolate, and ®Coca Cola Ltd. available. The  test subjects are  also advised to 
complete the test well nourished in order to minimise the risk of hypoglycaemia  . A fully functional and 
always accessible defibrillator (Lifepak Express Defibrillator, reaplus.ch) is located in our institution. This 
information is  communicated to the test persons (subject information). 
Furthermore, any injuries to the musculoskeletal system were defined as an exclusion criterion in order 
not  to provoke a relapse of a past injury. 
More information on securing the test subjects can be found in chap. 8.1.1. 
 
The test subject does not derive direct benefits from participating in the study. 

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3.8 
Justification of the choice of population 
(ClinO, Art 25d4, Art. 15-17; I/IT 6.2.6; AGEK 11.2) 
ICH: Description of the population to be studied. 
This series of studies will be conducted with healthy young volunteers. The risk of injury is considered 
low in this test subject population. 
 
Inclusion Criteria 
Young healthy adults aged 18 - 30 years 
• 
No surgical interventions on the 
musculoskeletal system in the 
trunk area and lower extremities 
• 
Injuries to the trunk and/or lower 
extremities that occurred more than 1 
year ago and no longer cause symptoms 
Anti-conception drugs 
Exclusion criteria 
Current injuries of any kind affecting the 
trunk and/or lower extremities 
Injuries to the torso and/or lower 
extremities  that occurred less than 1 year 
ago 
Injuries to the trunk and/or lower 
extremities that occurred more than 1 
year ago and are still causing symptoms. 
Fear of cooling intervention 
Taking medication of any kind (even 
self-purchased) 
Pacemakers & cardiac arrhythmias 
Known circulatory problems Pregnancy 
Diagnosed skeletal static deviations 
Appendectomy less than 2 years ago 
Raynaud's syndrome 
 
 
The subjects will be comprehensively informed about the process and possible risks before they are 
confirmed to participate in the study. You will also receive the information in written form and have the 
opportunity to ask questions. The declaration of consent explains to them what their rights and obligations 
are when participating. In addition, they are informed that they may withdraw from participation at any 
time without giving reasons, without incurring any disadvantages as a result. 

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4 
STUDY OBJECTIVES 
 
(ICH/E6 6.3; AGEK 3; SPIRIT #7) 
ICH: A detailed description of the objectives and the purpose of the trial. 
 
4.1 
General objectives 
In this study, the effect of a 20-minute cooling application (+8 °C) on the subjective muscle soreness and 
general fatigue data, as well as the objectively measurable MVIC of the ventral thigh muscles and the 
maximum vertical jump height after exhausting physical exertion will be investigated. The effects of the 
cooling application are  compared with a thermoneutral application (+32 °C) and compared directly, 24 
hours, 48 hours and 72 hours after the interventions. The aim is to substantiate the state of scientific 
knowledge and to provide therapists and physicians with further insights. This study can benefit all those 
who work with amateur and elite athletes. 
 
4.2 
Primary objectives 
Post-Activity Cooling - Subproject A 
 
In this subproject, the effect of post-activity cooling on objective and subjective recovery parameters is 
measured and compared to thermoneutral post-activity application. 
 
Objective recovery parameters: 
 
Maximum vertical jump height (cm) 
Subjective recovery parameters: 
Muscle soreness in the legs (VAS) General fatigue 
data  (BORG) 
 
 
Preactivity Cooling - Subproject B 
In this subproject, the Effect the Pre-activity cooling 
measured on objective and 
subjective performance parameters and compared with the thermoneutral preactivity application. 
Objective Performance Parameters: 
 
Maximum 
Arbitrary 
Isometric 
Muscle contraction 
(MVIC) 
the 
ventral 
thigh muscles (mV) 
 
Subjective performance parameters: Muscle 
soreness in the legs (VAS) 
Information on general exhaustion (BORG) 

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4.3 
Secondary Objectives  
None 
 
4.4 
Other safety aspects (long-term) 
No short-term risks are to be expected from this study other than those discussed so far.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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5 
STUDIES OUTCOMES 
 
(I/E6 6.4.1; AGEK 4.1; SPIRIT #12) 
ICH: A specific statement of the primary endpoints and the secondary endpoints, if any, tobe 
measured during the trial. 
 
5.1 
Primary outcomes 
 
Muscle activity (EMG) 
 
 
Increased activation of a muscle can be  measured in a larger amplitude of the EMG signal. For this 
purpose, the absolute amplitude [mV] and the lntergral over a certain time interval [mVs] are used in this  
study. 
MVIC is measured on the Cor 1 - ergometer chair [Nm] in 90° knee flexion. The measurement 
moments take place directly, 24 hours, 48 hours and 72 hours after the intervention. 
 
Jump height measurement 
 
The jump height after the load is determined with a jump height measuring plate designed for this purpose 
(Just Jump Plate, Probotics lnc., Huntsville, USA). The test subjects assume a standing position on the 
plate. The test subjects are allowed to start from the squatting position (countermovement jump)  to 
measure  the jump height.The arms must be placed at the hips during the entire movement  . The 
measurement moments take place directly, 24 hours, 48 hours and 72 hours after the intervention. 
 
Subjective muscle soreness 
 
The subjects reported their subjective feeling of muscle soreness on a visual analogue scale (VAS). The 
scale will  be scaled from "0" (no muscle soreness present) to "10" (largest imaginable muscle soreness) 
in cm increments. The measurement moments take place directly, 24 hours, 48 hours and 72 hours after 
the intervention. 
 
Subjective information on general exhaustion 
 
The subjects indicate their subjective general feeling of exhaustion on a visual analogue scale (VAS).  
The scale is from "O" (no general exhaustion present) to 
"10" (greatest conceivable general exhaustion) can be scaled in cm steps. The measurement moments 
take place directly, 24 hours, 48 hours and 72 hours after the intervention. 
 
 
5.2 
Secondary outcomes 
None available 

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5.3 
Safety Aspects 
No further outcomes are included that serve safety. 
Stopping the experiment is up to the testers' assessment of the subject's resilience. If this is estimated to 
be too low, the examiner can discontinue the experiment. 
If, according to his or her own subjective assessment, the subject does not feel well, he or she can 
discontinue the experiment and  withdraw his or her participation in the study. There are no disadvantages 
for him as a result. 

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6 
DESIGN STUDIES 
 
(I/EG6.4; AGEK 4; SPIRIT #8) 
6.1 
Study design and justification 
 
Randomized, controlled, double-blind study 
It is an observational study of Cat. A (ClinO, Art. 20), whereby a tested medical device is tested on young, 
healthy volunteers during the intervention. 
The group size of the participants is 40 people each (sub-protocols A & B) and 20 respectively 
 
people (subproject A) and 20 people (subproject B). 
The group classification of the test setup to be tested (cooling vs. thermoneutral 
application) will be randomized. 
 
Blinding of the participants is ensured by the use of a thermoneutral application. The examiners are 
blinded by the addition of another examiner who operates the apparatus. The responsible statistician is 
blinded and has no access to the personal data of the test persons and is not present when the data is 
collected. 
 
6.2 
Method for minimizing influence 
(ICH/EG6.4.3; AGEK 4.3; SPIRIT #16, 17) 
ICH: A description of the measures taken to minimize/avoid bias, including: Randomization, 
Blinding. 
6.2.1 
Randomization 
The allocation to the various groups and persons of the sub-protocols takes place randomly with the 
drawing of a lot. 
 
 
 
6.2.2 
Blinding 
Blinding of the participants is prevented by the use of a thermoneutral application 
warranted. The examiners are blinded by the addition of another examiner who operates the apparatus. 
The responsible statistician is blinded and has no access to the personal data of the test persons and is 
not present when the data is collected. 
6.2.3 
Other Methods 
No other methods are used. 
 
6.3 
Code break procedure (ICH/EG6.4.8; AGEK 4.2; SPIRIT 
#17b) 
ICH: Maintenance of trial treatment randomization codes and procedures for breaking codes. 
There is no provision for the statistician to be blinded. 

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7 
POPULATION STUDIES  
 
7.1 
Inclusion Criteria 
 
 
Inclusion Criteria 
Young healthy adults aged 18 - 30 years 
No surgical interventions on the 
musculoskeletal system in the 
 
Torso area and the lower 
extremities 
Injuries to the trunk and/or lower 
extremities that occurred more than 1 
year ago and no longer cause symptoms 
Anti-conception drugs 
Exclusion criteria 
• 
Current injuries of any kind affecting 
the trunk and/or lower extremities 
Injuries to the torso and/or lower 
extremities that occurred less than 1 year 
ago 
Injuries to the trunk and/or lower 
extremities that occurred more than 1 
year ago and are still causing symptoms. 
Fear of cooling intervention Taking 
medication of any kind 
Type (also self-bought) 
Pacemakers & cardiac arrhythmias 
Known circulatory problems 
• 
Pregnancy 
• 
Diagnosed skeletal static 
deviations 
Appendectomy less than 2 years ago 
Raynaud's syndrome 
 
 
7.2 
Recruitment and screening 
(ClinO, Art 25, Appendix 3, 1.4 & 1.6; AGEK 5.1; SPIRIT #15) 
 
Recruitment 
It is advertised on the website (homepage & Facebook) of Thim van der laan University College 
Physiotherapy. The exact texts have been prepared according to the checklist of the Cantonal Ethics 
Commission Zurich. 

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As an advertisement (text visible): 
 
• 
Homepage of the Thim van der Laan Physio School: www.Physio school.Ch 
• 
Facebook page of the Thim van der Laan Physiotherapy 
School: https:www.facebook.com/physioschule 
 
 
Screening 
At the first contact, the pot. Participant informs about the course and risks of the study, as well as the 
conditions for and the amount of compensation. A checklist for contacting them by telephone serves as 
a basis. 
During the first telephone contact, a questionnaire is filled out by the study management to determine the 
suitability as a study participant. 
 
Advertisements, questionnaires and checklists for the first contact can be found in the supplement. 
 
 
7.3 
Group assignment 
The group assignment in the sub-protocols is hidden with the help of a lot in a sealed envelope, 
which is drawn under the supervision of the study director. The test subject number and the 
application are noted on this lot. The examiner sets the exam condition and only announces the 
subject number to the other examiners. At the end of the entire data collection , this auditor pools the 
data sets according to the application. 
 
7.4 
Discontinuation of study participation 
If a participant withdraws from the study, the lot of the allocation is returned to the pot in a new envelope 
and a new participant is sought. 
The already completed consent form is stored in the locked filing cabinet, data that has already been 
collected is stored, but is not included in the further data analysis of the study. 
The conditions for the termination of the experiment were described in chap. 5.4. 
There is no disadvantage for the participants if they discontinue their participation in 
the study. 

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8 
STUDY INTERVENTION 
 
8.1 
Medical Product ID 
 
 
8.1.1 
Intervention Product 
Zamar Therapy 
Zamar Therapy is a certified medical device according to European directives (Directive 93/42/EEC 
and ISO 13485:2012). The temperature can be reduced from -5.0 °C to +45 °C. The maximum 
adjustable treatment time is 1 hour. Cuffs ensure optimal contact with the corresponding body 
region. A coolant circulates continuously between the device and the man's boot. 
This device is used for the following indications: treatment of the musculoskeletal system (contusions, 
contractures, lesions of the second degree, hematomas), tendinogenic system (tendinitis, tenosynovitis, 
tendinopathy), bone-cartilage system (contusions, post fractures), capsuloligamentary system (sprains, 
torsions, Contusions of ligaments), postoperative, aesthetic surgery and to accelerate recovery time. 
In this study, temperatures of + 8 °C and thermoneutral temperatures ( + 32 °C) are used for 20 minutes. 
 
 
 
 
) 
 
Fig. 1: Zamar Therapy (www.zamarmedical.com) 
 
 
 
Securing the test subjects 
The temperature of 8 °C is a cooling temperature commonly used in the literature (cf. Ascensao et al., 
2011; Bailey et al., 2007; Crystal et al., 2013; Delextrat et al., 2013; lngram et al., 2009; Jakeman et al., 
2009; King et al., 2009; Leal et al., 2011; Paddon-Jones et al., 1997; Pointon et al., 2011; Pointen et al., 
2012; Sellwood et al., 2007; Yanagisawa et al., 2003). Nevertheless, the test subjects can stop the cold 
treatment at any time if they feel unwell. 
During the maximum and submaximal loads, the test subjects go to their personal performance limit. 
Although they are motivated by the examiners, they are not encouraged to exceed the personal 
performance threshold. The test subjects can be used in case of discomfort or If the personal performance 
limit is reached, stop the loads at any time. Furthermore, 2 examiners will be next to the subject during 
the jumping load in order to be able to catch him/her in case of circulatory problems. An emergency kit is 
available at all times during the examinations ( see Chapter 3.7. Risk/ Benefits). 

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8.1.2 
Packaging, labeling and use 
ICH: Also include a description of the dosage form, packaging, and labelling of the 
investigational product(s). 
Zamar Therapy is a certified medical device according to European directives (Directive 93/42/EEC and ISO 
13485:2012). 
 
 
8.1.3 
Storage 
The Zamar Therapy must be stored inside a room. The equipment is therefore located all year round in 
a closed room with room temperature and low humidity. 
 
 
 8.2 
Administration of the 
experiment (ICH/IT 6.4.4) 
Since no medication or invasive methods are used, chap. 8.2 - 8.4  and referred exclusively to chapter 
9. 
 
 
8.2.1 
Experimental intervention 
ICH: Description of and justification of the treatment(s) tobe administered, including the 
name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of 
administration, and the treatment period(s), including the follow-up period(s) for subjects for 
each investigational product treatment/trial treatment group/arm of the trial. 
Cooling application of + 8°C for 20 min on the right thigh 
8.2.2 
Control Intervention 
ICH: Description of and justification of the treatment(s) to be administered, including the 
name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of 
administration, and the treatment period(s), including the follow-up period(s) for subjects for 
each investigational product treatment/trial treatment group/arm of the trial. 
 
Thermoneutral application of + 32 °C for 20 min on the right thigh 
8.3 
Can / Device modifications 
(SPIRIT #11b) 
 
8.4 
Compliance with study Intervention 
(ICH/E6 6.6.3; AGEK Checklist 2, item 2; SPIRIT #11c) 
ICH: Procedures for monitoring subject compliance. 
Subjects are motivated to perform MVIC and jump height measurement to keep their compliance high. 
 
8.5 
Follow-up treatment of eliminated participants 
(ICH/E6 6.5.3; AGEK 9.2; SPIRIT #18b) 
I: .................. b) The type and timing of the data to be collected for withdrawn subjects. d) The 
follow-up for subjects withdrawn from investigational product treatment/trial treatment. 
Data already collected from eliminated participants will be stored, but will not be included in the further 
data analysis of the study. 
There is no disadvantage for the participants if they discontinue their participation in the study and no 
further interventions are necessary for follow-up treatment. 
If study participation was due to an injury occurred during study participation, 

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is aborted, it will be recorded and reported to the sponsor investigator (head of the research laboratory), 
study leader and supervisor of the study. Furthermore, the report is sent to the public liability insurance 
of Thim van der Laan University College Physiotherapy in Landquart. 
 
8.6 
Preventive measurements 
(I/IT 6.6.2; AGEK 9; SPIRIT #11d) 
ICH: Medication(s)/treatment(s) permitted (including rescue medication) and not permitted 
before and/or during the trial. 
The questionnaire asks about the intake of medication and excludes pregnancy. If static deviations are 
visible but not medically diagnosed, the study leader reserves the right to measure them (leg length 
difference, scoliosis angle) and thus exclude a test subject from participation. 
 
 
8.7 
Accompaniments 
(I/IT 6.6.2; AGEK 9; SPIRIT #11d) 
ICH: Medication(s)/treatment(s) permitted (including rescue medication) and not permitted 
before and/or during the trial. 
No further side effects are expected from study participation. 
 
 
8.8 
Liability 
(I/IT 6.4.7; AGEK Checklist 2, item 1; SPIRIT 11c) 
ICH: Accountability procedures for the investigational product(s), including the placebo(s) and 
comparator(s), if any. 
The experiments take place exclusively in the research laboratory of the Thim van der Laan University 
College Physiotherapy in Landquart. This means that there is no transport of the products and measuring 
instruments used. There is therefore no liability for the transport of the product . 
 
 
8.9 
Return of the medical device 
(AGEK Checklist 2, item 1; SPIRIT 11c) 
 
The Zamar Therapy is returned to the manufacturer after the end of the measurement period. 

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9 
STUDIES STRUCTURE & 
EVALUATION (ICH/E6 6.7, 6.8; AGEK 6, 
7; SPIRIT #18a) 
9.1 
Schedules of the various protocols 
1. Subject Information & Informed Consent 
10 Min 
2. Preparation of the subject 
15 min 
3. Running the Test Log (Sublogs) 
 
Partial Protocol A: first measurement + intervention - approx. 60 min 
Cooling vs. Thermoneutral application on recovery 
Cooling panel 
Thermoneutral Application Group 
1. 3  X 
Vertical 
Leaps 
VAS 
& 
BARROW 
1.  3 x Vertical Jumps, VAS & BARROW 
(max 5 min) 
(max 5 min) 
Max 1 min break 
Max 1 min break 
2. 1 minute max vertical Leaps, VAS  & 
2.  1 minute max vertical jumps, VAS & 
BARROW (1 min) 
BARROW (1 min) 
Max 5 min break 
Max 5 min break 
3. Cooling (20 min) 
3. Thermoneutral application (20 min) 
Max 1 min break 
 
Max 1 min break 
4. 3  X  Vertical 
Leaps,  VAS  & 
BARROW 
4.  3 x Vertical JumpeVAS & BARROW 
(max 5 min) 
(max 5 min) 
Directly after the Intervention 
immediately after the intervention 
5. 3 
X 
Vertical 
Leaps,  VAS 
& 
BARROW 
5.  3 x Vertical Jumps, VAS & BARROW 
(max 5 min) 
(max 5 min) 
24 hours after the intervention 
24 hours after the intervention 
6. 3 
X 
Vertical 
Jumps, VAS 
& 
BARROW 
6.  3 x Vertical Jumps, VAS & BARROW 
(max 5 min) 
(max 5 min) 
48 hours after the intervention 
48 hours after the intervention 
7. 3 
X 
Vertical 
Leaps,  VAS 
& 
BARROW 
7.  3 x Vertical jumps, VAS & BARROW 
(max 5 min) 
(max 5 min) 
72 hours after the intervention 
72 hours after the intervention 

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Partial Protocol B: first measurement + intervention - approx. 60 min 
Cooling vs. Thermoneutral application on performance 
Cooling panel 
1. 1 x MVIC, VAS & BORG (max 3 
min) Max 1 min break 
2. Cooling (20 min) 
Max 1 min break 
3. 60 % MVIC for 1 min (2 min) 
Max 5 min break 
4. 1 x MVIC, VAS & BORG (max 5 min) 
immediately after the intervention 
5. 1 x MVIC, VAS & BORG (max 5 min) 
24 hours after the intervention 
6. 1 x MVIC, VAS & BORG (max 5 min) 
48 hours after the intervention 
7. 1 x MVIC, VAS & BORG (max 5 min) 
72 hours after the intervention 
Thermoneutral Application Group  
1. 1 x MVIC, VAS & BORG (max 3 
min) Max 1 min break 
2. Thermoneutral application (20 min) 
Max 1 min break 
3. 60 % MVIC for 1 min (2 min) 
Max 5 min break 
4. 1 x MVIC, VAS & BORG (max 5 min) 
immediately after the intervention 
5. 1 x MVIC, VAS & BORG (max 5 min) 
24 hours after the intervention 
6. 1 x MVIC, VAS & BORG (max 5 min) 
48 hours after the intervention 
7. 1 x MVIC, VAS & BORG (max 5 min) 
72 hours after the intervention 
 
Sub-protocol 
Total time commitment 
Visits 
A 
Approx. 80 min 
Once 60 min and 3 times for max 5 
min 
B 
Approx. 80 min 
Once 60 min and 3 times for max 5 
min 
 
9.2 
Measuring outcomes 
ICH: Specification of the efficacv parameters. Specification of safetv parameters. 
Sub-protocol 
Total time commitment 
Measurement parameters 
A 
Approx. 80 min 
(1x 60 min & 3 x 5 min) 
Measurements: 
Jump height 
VAS & BORG 
B 
Approx. 80 min 
(1x 60 min & 3 x 5min) 
Measurements: 
MVIC 
VAS & BORG 

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9.2.1 
Measurement of primary outcomes 
ICH: Methods and timing for assessing, recording, and analysing of efficacy & safety 
parameters. 
The following data are collected during all tests  described in the sub-protocols in chap. 9.1. 
 
MVIC of the ventral thigh muscles 
Muscle activity is  measured using the sEMG active sensors wireless surface electromyogram system  
from PLUXwireless bodysignals S.A. {physioplux.com).  Skin-friendly electrodes from Synmedig AG  are 
used: Ambu® Blue Sensor N.   MVIC is measured on the Cor 1 - ergometer chair [Nm] in 90° knee flexion. 
The electrodes are  placed according to the internationally recognized SENIAM guidelines (SENIAM 
project 2013). 
 
Jump height (cm) 
The jump height after the load is  determined with  a jump  height measuring plate designed for this 
purpose (Just Jump Plate, Probotics lnc. , Huntsville, USA). The test subjects assume a standing position 
on the plate. The test subjects are allowed to  start from the squatting position (countermovement jump) 
to measure the jump height. The arms must  be placed at the hips during the entire movement 
(countermovement jump). 
 
Subjective muscle soreness (VAS) 
The subjects reported their subjective feeling of muscle soreness on a visual analogue scale (VAS). The 
scale will be scaled from "0" (no muscle soreness present) to "10" (greatest conceivable muscle soreness) 
in cm  steps. 
 
Subjective data on general exhaustion (BORG) 
The subjects indicate their subjective general feeling of exhaustion on a visual analogue scale (VAS). The 
scale is from "O" (no general exhaustion present) to 
.,10" (greatest conceivable general exhaustion) can be scaled in cm steps. 
 
9.2.2 
Measurement of secondary outcome 
None available 
9.2.3 
Survey of further outcomes 
None available 
9.2.4 
Collection of safety parameters 
No  corresponding parameters are collected. 

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9.2.4.1  
9.2.4.2 Adverse events 
 
 
9.2.4.3 Laboratory parameters 
 
 
9.2.4.4 Vital signs 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9.2.5 
Collection of data in case of early termination of studies 
For the participants, there is no disadvantage in the event of an (arbitrary) discontinuation of study 
participation and no further interventions are necessary for follow-up treatment. 
However, if the study participation was discontinued due to an injury occurred during the study 
participation, this will be recorded and reported to the sponsor investigator (head of the research 
laboratory), study leader and supervisor of the study. The report is then sent to the business liability 
insurance of Thim van der Laan University College Physiotherapy in Landquart. 
 
The following are recorded: 
Date and time of the incident 
 
Course of the incident 
Persons involved & witnesses Study 
ID (assigned by the CEC) 
Personal details of the person concerned (if not previously recorded) 
 
 
 
 
 
 
 
 

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9.3 
Procedure at each visit of the test subjects 
9.3.1 
Single measurement 
Sub-protocols A and B are multiple visits. 
9.3.2 
Multiple visits 
(e.g. Visit 1, Baseline (Day e.g., 1): List all exams/tests, actions to be performed according to flow chart 
(9.1) including also e.g., Dispense of trial medication, Scheduling of next visit) 
 
The sub-protocols A and B are multiple visits with a duration of about 80 minutes each, which takes 
place as follows: 
 
1. Subject Information & Informed Consent 
The subjects will be comprehensively informed about the process and possible risks before they are 
confirmed to participate in the study  . You will also receive the information in written form and have the 
opportunity to  ask questions. The declaration of consent explains to them what their rights and obligations 
are when participating and that they may withdraw from participation at any time without giving reasons  
, without incurring any disadvantages as a result. More detailed information can be found in Chapter 2.7. 
 
2. Preparing the subject 
If the subject  is willing to participate, he or she is instructed to change in a separate room: 
 
- Subproject A 
this sub-project does not require any further preparations. 
 
- Subproject B 
First, the areas for the placement of the electrodes are marked with a skin-friendly pen (eyeliner) and, 
if necessary, individual areas of the EMG electrode placements are shaved (both were explained to the 
test subject beforehand according to a checklist). Then the electrodes  are attached. 
 
3. Measurements 
The tests are carried out in the same way as in the corresponding sub-protocol and the data is collected. 
 
4. Indemnification and Conclusion 
After completion of the individual measurement, the test subject  is asked to  change again in a separate 
room. Afterwards, they are asked how they are feeling. The subject is asked to report back  to the 
laboratory at intervals of 24 hours (up to a maximum of 72 hours)  to carry out the follow-up measurement. 
After completion of the measurements, the test subject will be happy to receive the compensation to 
which he/she is entitled. Information in the advertisement: 
Flat rate Str. 200 .- after completion of the 72-hour measurement. 

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Subproject A 
In subproject A, the subjects  return to the laboratory 24 hours, 48 hours and 72 hours after the 
intervention. Here, the maximum jump height during 3 attempts is determined again. Furthermore,  the 
subjective muscle soreness and general states of exhaustion are recorded. 
 
Subproject B 
In subproject B  , the subjects return to the laboratory 24 hours, 48 hours and 72 hours after the 
intervention. Here  the MVIC  is determined again. Furthermore, the subjective muscle soreness and 
general states of exhaustion  are recorded. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10 
SAFETY 
 
Observational study Cat. A ClinV (Art. 20) 
 
The test subjects are not given  medication or tissue samples are taken. No invasive methods 
are  used. 
 
No  further security aspects are expected. 
 
10.1 Drug studies 
 
10.1.1 Definition and assessment of (serious) adverse events and other safety related events 
ICH: Procedures for eliciting reports of and for recording ... adverse event and intercurrent 
illnesses. 
 
 
10.1.2 Reporting of serious adverse events (SAIE) and other safety related events 
(KlinV Art. 37) 
ICH: Procedures for ... reporting adverse event and intercurrent illnesses. 
 
 
10.1.3 Follow up of (Serious) Adverse Events 
(ICH/EG 6.8.4; SPIRIT #30) 
ICH: The type and duration of the follow-up of subjects after adverse events. 
 
 
10.2 Medical Device Category C studies 
 
 
10.2.1 Definition and Assessment of (Serious) Adverse Events and other safety related events 
(MD: ISO 14155) 
 
 
10.2.2 Reporting of (Serious) Adverse Events and other safety related events 
 
 
10.2.3 Follow up of (Serious) Adverse Events 
(SPIRIT #30) 
 
 
10.3 Medical Device Category A studies 
This study is a category A clinical observational study in accordance with the Swiss Ordinance on Clinical 
Trials in Human Research (ClinO: Art. 20). 
It is a study with 20 or fewer subjects in each experimental group. The  study also focuses on basic 
findings. The monitoring for quality assurance is  carried out by Prof. Dr. Peter Clarys. 

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10.3.1 Definition and Assessment of safety related events 
If a circulatory problem  leads to an injury, this is assessed as a safety-relevant event  and must be 
investigated in more detail  before continuing the study. 
 
The following are recorded: 
Date and time of the incident 
Incident Procedure  
Persons involved & witnesses Study 
ID (assigned by the CEC) 
Personal details of the person concerned (if not previously recorded) 
 
10.3.2 Reporting of Safety related events 
A safety-related event is logged and  immediately reported to the sponsor investigator (head of the 
research laboratory), study leader and supervisor of the study. 
The CEC will be informed as soon as possible and appropriate changes to the protocol of the study will 
be requested. Further explanations on this can be found in chap. 2.10. Safety and protective measures 
must be reimbursed to the responsible CEC within 2 days  . 
The report  continues to the public liability insurance of Thim van der Laan University College 
Physiotherapy in Landquart. 

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11 
STATISTICAL METHODS 
 
 
 
11.1 Hypotheses & Factors 
Subprojects A and B 
 
Jump height (cm) 
 
 
 
Subproject A 
HO 
The jump height is not increased by the post-activity cooling compared to 
thermoneuapplication during a 72-hour recovery period. 
 
H1 
The Jump height becomes through the Post-activity cooling increased opposite 
thermoneutral application during a 72-hour recovery period. 
 
Subjective muscle soreness (VAS) 
HO 
The subjective muscle soreness information is not reduced by post-activity cooling 
compared to thermoneutral application for 72 hours. 
H1 
The subjective muscle soreness information is lower due to post-activity cooling 
compared to thermoneutral application for 72 hours. 
 
Subjective data on general exhaustion (BORG) 
HO The subjective information on general fatigue is not reduced by post-activity cooling 
compared to thermoneutral application for 72 hours. 
H1 The subjective data on general fatigue are lower with post-activity cooling compared to 
thermoneutral application for 72 hours. 
 
Subproject B 
MVIC (mV) 
HO 
MVIC performance is measured by the pre-activity cownot increased compared to 
thermoneutral application for 72 hours 
H1 
The MVIC Efficiency is increased by pre-activity cooling compared to thermoneutral 
application for 72 hours 
 
Subjective muscle soreness ( VAS) 
HO 
The subjective muscle soreness data is not reduced by the pre-activity cooling 
compared to thermoneutral application for 72 hours. 
H1 
The subjective muscle soreness is lower due to the pre-activity cooling compared to 
thermoneutral application for 72 hours. 

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Subjective data on general exhaustion (BORG) 
HO The subjective information on general fatigue is not reduced by pre-activity cooling compared 
to thermoneutral application for 72 hours. 
H1 The subjective information on general fatigue is lower due to pre-activity cooling compared to 
thermoneutral application for 72 hours. 
 
A 2-factor analysis will be carried out in both projects.  Factor 1: 
Intervention (cooling vs. Thermoneutral application) Factor 2: 
Time (0, 24 hours, 48 hours, 72 hours) 
11.2 Sample Size 
The planned number of 20 subjects (project A), or 20 subjects (Project B) correspond to the group sizes 
of the comparable cooling studies (cf. (Ascensao et al. 2011, Bailey et al. 2007, Crystal et al. 2013, 
Rowsell et al. 2009, De Pauw et al. 2014, Guilhem et al. 2013, Jakeman et al. 2009, Howatson et al. 
2009, Montgomery et al. 2008, Rupp et al. 2012, Yanagisawa et al. 2003,  e.g.). 
 
11.3 Criteria for the statistical use of data in the case of incomplete data sets 
  Only data from subjects  who have completed the entire protocol will be  included in the study. This 
ensures that all data has been collected under the same conditions and thus remains homogeneous and 
comparable. 
 
11.4 Scheduled analyses 
11.4.1 Datasets and Data Populations 
Only complete data sets will be included in the study. Data that contains only part of the protocol is 
not included in the analysis. No new subject is being sought to replace the missing data. 
 
 
11.4.2 Primary Analysis 
The statistical data analysis is carried out by Prof. Dr. Jean-Pierre Baeyens after completion of the data 
collection of the respective sub-protocol. 
 
Repeated measures analysis of variance (MANOVA) 
2 factors: 
Protocol A 
 
Intervention (cooling vs. Thermoneutral application) Time 
( 0, 24 hours, 48 hours, 72 hours) 

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Protocol B 
 
Intervention (cooling vs. Thermoneutral application) Time 
( 0, 24 hours, 48 hours, 72 hours) 
 
The significance level is set at P < 0.05,  and the statistical data analysis is carried out  with SPSS 22. 
 
 
11.4.3 Secondary Analysis 
Non-existent. 
11.4.4 Interim analyses 
The data is processed after  the end of the respective subprotocol. Thus, the data analysis for the 
entire study takes place in stages.No additional interim analyses  are planned. 
11.4.5 Security analyses 
 
 
11.4.6 Deviations 
Deviations from the planned statistical analysis are recorded and justified and reported to the CEC in  the 
annual report. 
11.5 Drop-outs and missing data 
If a test subject does not complete the experiment, any data that has already been collected is retained, but 
is not further incorporated  into the final data analysis.  

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12 
QUALITY ASSURANCE AND CONTROL 
 
12.1 Data Archiving 
12.1.1 Forms 
Data protection and confidentiality are guaranteed and no personal data is presented or published. The 
signed declaration of consent, as well as the completed questionnaire with the other personal details, are 
kept in the original as a study document in a locked filing cabinet. 
 
 
Direct access to the personal data is only allowed to authorized persons of the CEC. 
 
12.1.2 Specification of forms 
The data collected in writing is recorded in the form listed in the enclosures and is marked as study data. 
They are therefore subject to data protection and are regulated in accordance with the provisions set out 
in chap. 12.1.1. 
12.1.3 Archiving of data 
The data collected will be kept for 1O years. Data protection will continue to be guaranteed. 
 
 
12.2 Data management 
12.2.1 Data Management System 
The raw data of muscle activity is processed with the software of PLUXwireless biosignals S.A. The jump 
height is determined with a jump height measuring plate designed for this purpose (Just Jump Plate, 
Probotics lnc., Huntsville, USA). Excel is used for further data analysis. For the be used. 
12.2.2 Data security and backup 
The digital data will be anonymized and treated confidentially, and access to the personal data will not 
be allowed to third parties. The digital data collected is stored solely on the institute's own computers and 
is not passed on to any external persons or transferred to other computers. Access to the computers of 
the research laboratory at Thim van der Laan University College Physiotherapy is only available to the 
principal investigator and the investigators (listed in Chapter 1), as well as persons authorised by the 
CEC. 
 
 
12.2.3 Analysis and archiving 
After collection, the digital data is anonymized and stored on another external hard drive for further 
backup. This is stored in a locked filing cabinet to ensure data protection. 

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12.2.4 Validation of electronic data 
Immediately after data collection , the quality of the data is checked and verified with the help of the visual 
representation. 
 
12.3 Monitoring 
The data collected can be viewed by authorised persons at any time (see section 12.2.2) 
 
12.4 Audits and inspections 
A report on the current status of the study is sent monthly to the study supervisor (Prof. Dr. Peter Clarys). 
This also includes demonstrating and presenting results and statistical analyses. 
An  annual report on the course of the study will be submitted to the CEC. Authorized persons of the 
CEC can view the data forms and the digital data on the institute's own computers at any time. 
Data protection is guaranteed at all times. 
 
12.5 Confidentiality and data protection 
The examiners ensure that the privacy of the participant is maintained. In particular, data protection and 
confidentiality are guaranteed and  no personal data is presented or published. The signed declaration 
of consent, as well as the completed questionnaire with the other personal details, are kept in the 
original as a study document in a locked filing cabinet. 
The digital data will be anonymized and treated confidentially, and access to the personal data will not 
be allowed to third parties. The digital data collected is stored solely on the institute's own computers and 
is not passed on to any external persons or transferred to other computers. 
 
Direct access to the personal data is only allowed to authorized persons of the CEC. 
 
 
12.6  Storage of biological material and related health Data 

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13 
PUBLICATION AND DISCLOSURE OF DATA 
 
The examiners ensure that the privacy of the participant is maintained. In particular, the data 
protection and confidentiality of the data are guaranteed and no personal data is presented or 
published nor passed on to outsiders and unauthorized persons. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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14   F I N A N C I N G  A N D  S U P P O R T  
 
 
14.1 Financing 
(ClinO, Art. 25i) 
The study is funded by the University of Applied Sciences and Arts Southern Switzerland, 
Physiotherapy Graubünden. The auditors are employed by this institute and are  remunerated for 
their work on this study in accordance with their employment contracts. 
 
14.2 Further support 
 
The Zamar  Therapy thermotherapy device is kindly provided by the manufacturer during the 
 
entire duration of study. There is no written agreement. 
 
Zamar Medical d.o.o. Zamar Medical 
 
Mate Vlasica 26 
52440 Porec, 
Croatia 
T +385 52 496 111 
 
 
info@zamarmedical.com 
www.zamarmedical.com 
15  I N S U R A N C E  
 
(ClinV Art 12, 13; I/ES 6.14, AGEK 10.3; SPIRIT#30) 
I: .......... and insurance if not addressed in a separate agreement. 
There is a public liability insurance for the Thim van der Laan Univesity College Physiotherapy in Landquart, 
where  the study is being conducted. 

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16 
REFERENCES 
(ME/EG6.2.7) 
ICH: References to literature and data that are relevant to the trial, and that provide 
background for the trial. 
Ascensao, A., et al., Effects of cold water immersion on the recovery of physical performance and 
muscle damage following a one-off soccer match. J Sports Sei, 2011. 29(3): p. 217-25. 
 
Bacon, N.T., et al., Effect of two recovery methods on repeated closed-handed and open-handed 
weight-assisted pull-ups. J Strength Cond Res, 2012. 26(5): p. 1348-52. 
 
Bailey, D.M., et al., lnfluence of cold-water immersion on indices of muscle damage following prolonged 
intermittent shuttle running. J Sports Sei, 2007. 25(11): p. 1163-70. 
 
Banfi, G., et al., Whole-body cryotherapy in athletes. Sports Med, 2010. 40(6): p. Letter 509-17. 
 
Barnett, A., Using recovery modalities between training sessions in elite athletes: does it help? Sports 
Med, 2006. 36(9): p. 781-96. 
 
Bastos, F.N., et al., Effects of cold water immersion and active recovery on post-exercise heart rate variability. 
lnt J Sports Med, 2012. 33(11): p. 873-9. 
 
Bleakley, C., et al., Cold-water immersion (cryotherapy) for preventing and treating muscle soreness 
after exercise. Cochrane Database Syst Rev, 2012. 2: p. CD008262. 
 
Bogerd, N., Perret, C., Bogerd C.P., Rossi, R.M., Daanen, A.M., The effect of pre-cooling on cooling 
efficiency and exercise performance. J Sports sei. 2010 May; 28(7):771-9 
 
Broatch, J.R., A. Petersen, and D.J. Bishop, Postexercise cold water immersion benefits are not greater 
than the placebo effect. Med Sei Sports Exerc, 2014. 46(11): p. 2139-47. 
 
Crowe, M.J., D. O'Connor, and D. Rudd, Cold water recovery reduces anaerobic performance. lnt J 
Sports Med, 2007. 28(12): p. 994-8. 
 
Crystal, N.J., et al., Effect of cryotherapy on musc/e recovery and inflammation fol/owing a baut of damaging 
exercise. Eur J Appl Physiol, 2013. 113(1O): p. 2577-86. 
 
Delextrat, A., et al., Effects of sports massage and intermittent co/d-water immersion on recovery from 
matches by basketba/1 players. J Sports Sei, 2013. 31(1): p. 11-9. 
 
De Pauw, K., et al., Effect of recovery inteNentions on cycling performance and pacing strategy in the 
heat. lnt J Sports Physiol Perform, 2014. 9(2): p. 240-8. 

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Elias, G.P., et al., Effects of water immersion on posttraining recovery in Australian footballers. lnt J 
Sports Physiol Perform, 2012. 7(4): pp. 357-66. 
 
Eston, R. and D. Peters, Effects of cold water immersion on the symptoms of exercise-induced muscle 
damage. J Sports Sei, 1999. 17(3): p. 231-8. 
 
Goodall, S. and G. Howatson, The effects of murtiple cold water immersions on indices of muscle damage. J 
Sports Sei Med, 2008. 7(2): p. 235-41. 
 
Grahn, D.A., J.L. Dillon, and H.C. Heller, Heat lass through the glabrous skin surfaces of heavily insulated, 
heat-stressed individuals. J Biomeeh Eng, 2009. 131(7): p. 071005. 
 
Gregson, W., et al., lnf/uence of cold water immersion on limb and cutaneous blood flow at rest. Am J 
Sports Med, 2011. 39(6): p. 1316-23. 
 
Guilhem, G., et al., Effects of air-pulsed cryotherapy on neuromuscular recovery subsequent to exercise-
induced muscle damage. Am J Sports Med, 2013. 41(8): p. 1942-51. 
 
Hausswirth, C., et al., Effects of whole-body cryotherapy vs. far-infrared vs. passive modalities on 
recovery from exercise-induced muscle damage in highly-trained runners. PLoS One, 2011. 6(12): p. 
e27749. 
 
Heyman, E., et al., Effects of four recovery methods on repeated maximal rock climbing performance. 
Med Sei Sports Exere, 2009. 41(6): p. 1303-10. 
 
Howatson, G., S. Goodall, and K.A. van Someren, The influence of cold water immersions on 
adaptation following a single bout of damaging exercise. Eur J Appl Physiol, 2009. 105(4): p. 615-
21. 
 
lngram, J., et al., Effect of water immersion methods on post-exercise recovery from simulated team sport 
exercise. J Sei Med Sport, 2009. 12(3): p. 417-21. 
 
Jakeman, J.R., R. Macrae, and R. Eston, A single 10-min bout of cold-water immersion therapy after 
strenuous plyometric exercise has no beneficial effect on recovery from the symptoms of exercise 
induced muscle damage. Ergonomics, 2009. 52(4): p. 456-60. 
 
King, M. and R. Duffield, The effects of recovery interventions on consecutive days of intermittent sprint 
exercise. J Strength Cond Res, 2009. 23(6): p. 1795-802. 
 
Kuligowski, L.A., et al., Effect of whirlpool therapy on the signs and symptoms of delayed-onset muscle 
soreness. J Athl Train, 1998. 33(3): p. 222-8. 
 
Leal Junior, E.C., et al., Comparison between cold water immersion therapy (CWIT) and light emitting 
diode therapy (LEDT) in short-term ske/etal muscle recovery after high-intensity exercise in athletes- 
preliminary results. Lasers Med Sei, 2011. 26(4): pp. 493-501. 
 
Leeder, J., et al., Cold water immersion and recovery from strenuous exercise: a meta-analysis. Br J 
Sports Med, 2012. 46(4): p. 233-40. 

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Myrer, W.J., et al., Muscle Temperature ls Affected by Overlying Adipose When Cryotherapy ls Administered. 
J Athl Train, 2001. 36(1): p. 32-36. 
 
Paddon-Jones, D.J. and B.M. Quigley, Effect of cryotherapy on muscle soreness and strength folfowing 
eccentric exercise. lnt J Sports Med, 1997" 18(8): p. 588-93. 
 
Pointen, M. and R. Duffield, Cold water immersion recovery after simulated collision spart exercise. 
Med Sei Sports Exerc, 2012. 44(2): p. 206-16. 
 
Pointon, M., et al., Cold water immersion recovery following intermittent-sprint exercise in the heat. 
 
Eur J Appl Physiol, 2012. 112(7): p. 2483-94. 
 
Pointon, M., et al., Cold application for neuromuscular recovery following intense lower-body exercise. 
Eur J Appl Physiol, 2011. 111(12): p. 2977-86. 
 
Pournot, H., et al., Short term effects of various water immersions on recovery from exhaustive intermittent 
exercise. Eur J Appl Physiol, 2011. 111 (7): p. 1287-95. 
 
Rowsell, G.J., et al., Effects of cofd-water immersion on physicaf performance between successive 
Matches in High-Performance Junior Male Soccer Players. J Sports Sei, 2009. 27(6): p. 565-73. 
 
Rupp, K.A., et al., The effect of cold water immersion on 48-hour pertormance testing in collegiate 
soccer players. J Strength Cond Res, 2012. 26(8): p. 2043-50. 
 
Sellwood, K.L., et al., /ce-water immersion and delayed-onset muscle soreness: a randomised controlled trial. 
Br J Sports Med, 2007. 41(6): p. 392-7. 
 
Stanley, J., J.M. Peake, and M. Buchheit, Consecutive days of cold water immersion: effects on cycling 
performance and heart rate variability. Eur J Appl Physiol, 2013. 113(2): p. 371-84. 
 
Tseng, C.Y., et al., Topical cooling (icing) delays recovery from eccentric exercise-induced muscle damage. J 
Strength Cond Res, 2013. 27(5): p. 1354-61. 
 
Tucker, T.J., et al., Effect of local cold application on glycogen recovery. J Sports Med Phys Fitness, 
2012. 52(2): p. 158-64 
 
Vaile, J., et al., Effect of hydrotherapy on the signs and symptoms of de/ayed onset muscle soreness. 
Eur J Appl Physiol, 2008. 102(4): p. 447-55. 
 
Wegmann, M., Faude, 0., Poppedieck, W., Hecksteden, A., Fröhlich, M. Meyer, T. Pre-cooling and 
Sports Performance - A Meta-Analytical Review. Sports Med. 2012 Jul 1;42(7):545-64. 
 
White, G.E. and G.D. Wells, Co/d-water immersion and other forms of cryotherapy: physiological changes 
potentially affecting recovery from high-intensity exercise. Extrem Physiol Med, 2013. 2(1): p. 

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26. 
 
Yanagisawa, 0., et al., Evaluations of cooling exercised muscle with MR imaging and 31P MR 
spectroscopy. Med Sei Sports Exerc, 2003. 35(9): p. 1517-23. 
-COO/ING and Sports Performance - a meta-analytical review. Sports Med. 2012 Jul 1;42(7):545-64. 
 
17 
APPENDIX 
 
ICH: (NOTE: Since the protocol and the clinical trial/study report are closely related, further 
relevant information can be found in the ICH Guideline for Structure and Content of Clinical 
Study Reports.) 
 
1. Subject Information, Informed Consent & Demographic Data (Questionnaire) 
a. Sub-protocols A 
b. Sub-protocols B 
 
2. Subject recruitment (advertisements, checklist for initial contact) 
 
3. Data collection form for subject data 
a. Sub-protocols A 
b. Sub-protocols B 
 
4. Data Collection Form Measurements 
 
5. Protocol Synopsis 
 
6. Employee 
 
7. CVs of all examiners 
 
8. CE Certification Zamar Therapy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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