High Intensity Functional Training in the Rehabilitation of Cancer Survivors: A Protocol for a Pragmatic Clinical Trial
Phase: NA
Conditions: Cancer
Sponsor: Andreas Lund Hessner

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High  Intensity  Functional  Training  in  the  
Rehabilitation  of  Cancer  Survivors    
  
Study  protocol  of  a  pragmatic  clinical  trial  
 
 
Andreas  Lund  Hessner,  PT,  MSc  
Henning  Langberg,  Professor  
Jette  Vibe-­Petersen,  MD  
Karen  Trier,  PT,  Msc  
Maja  S.  Sommer,  PT,  PhD  
Rikke  Daugaard,  PT,  Msc  
Rasmus  Tolstrup  Larsen,  PT,  MSc  
  
Date:  June  26,  2019  
Clinical  trials  ID:  514-­0306/19-­3000  
  

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Title page 
Title 
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High Intensity Functional Training in the rehabilitation of cancer survivors: Study protocol of a 
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pragmatic clinical trial  
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Corresponding and first author: Andreas L. Hessner1, PT, MSc. (hessnerfysioterapi@gmail.com) 
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Henning Langberg1 
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Jette Vibe-Petersen2 
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Karen Trier2 
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Maja S. Sommer2 
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Rikke Daugaard2 
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Rasmus T. Larsen1, PT, MSc. (rala@sund.ku.dk) 
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Affiliation 
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1CopenRehab, Section of Social Medicine, Dept. of Public Health,  
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University of Copenhagen, Henrik Pontoppidansvej 6, 1., 2200 Copenhagen N. 
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2Centre for Cancer and Health Copenhagen, Nørre Allé 45, 2200 Copenhagen N. 
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Text word count: 2922 
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Keywords: Crossfit, High Intensity Functional Training, Cancer, Cancer survivors 
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Table	  of	  contents	  
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TITLE	  ........................................................................................................................................................	  2	  
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BACKGROUND	  AND	  RATIONALE	  ...............................................................................................................	  3	  
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OBJECTIVE	  ................................................................................................................................................	  4	  
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METHODS:	  PARTICIPANTS	  INTERVENTIONS	  AND	  OUTCOMES	  ...................................................................	  5	  
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DESIGN	  AND	  STUDY	  SETTING	  ................................................................................................................................	  5	  
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ELIGIBILITY	  CRITERIA	  ...........................................................................................................................................	  5	  
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INTERVENTION	  ..................................................................................................................................................	  6	  
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PATIENT-­‐REPORTED	  OUTCOMES	  ...........................................................................................................................	  7	  
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Primary	  outcomes	  .....................................................................................................................................	  7	  
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Secondary	  outcomes	  .................................................................................................................................	  8	  
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RECRUITMENT	  ..................................................................................................................................................	  9	  
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METHODS:	  DATA	  COLLECTION,	  MANAGEMENT	  AND	  ANALYSIS	  ................................................................	  9	  
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DATA	  COLLECTION	  METHODS	  ...............................................................................................................................	  9	  
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DATA	  MANAGEMENT	  .......................................................................................................................................	  10	  
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STATISTICAL	  METHODS	  .....................................................................................................................................	  10	  
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ETHICS	  AND	  DISSEMINATION	  .................................................................................................................	  11	  
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LOCATIONS	  .....................................................................................................................................................	  12	  
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COLLABORATORS	  .............................................................................................................................................	  12	  
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PRINCIPAL	  INVESTIGATOR	  ..................................................................................................................................	  12	  
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AUTHORS	  CONTRIBUTIONS	  ................................................................................................................................	  12	  
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REFERENCES	  ...........................................................................................................................................	  13	  
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APPENDICES	  ...........................................................................................................................................	  15	  
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APPENDIX	  1	  ....................................................................................................................................................	  15	  
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Background and rationale 
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Cancer survivors experience a variety of ongoing physical and psychological symptoms associated 
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with both disease and treatment (1,2). Additionally, cancer survivors have an increased risk of 
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serious chronic health sequelae and comorbid conditions such as cardiovascular disease and 
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diabetes (2). These poor health outcomes among cancer survivors have led to greater emphasis on 
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interventions to enhance health outcomes such as health-related quality of life (HRQoL) and 
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cancer-related fatigue (CRF) (3).  
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Aerobic training as well as resistance training are both exercise interventions associated with a 
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number of health benefits in survivors of a variety of cancers (4–7). Thus, clinical guidelines 
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worldwide recommend both regular aerobic- and resistance training as an essential part of the 
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rehabilitation of cancer survivors during and after active cancer treatment (1,8,9). 
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Furthermore, aerobic training and resistance training performed at high intensity has been reported 
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as a feasible and safe intervention for patients with various different cancer diagnosis and in 
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different stages of cancer. It can provide objective physiological benefits as well as improve 
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HRQoL, CRF and depression among cancer survivors (4,5,7,10–12).  
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High Intensity Functional Training (HIFT) has been defined as a style of training that incorporates 
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functional, multimodal movements, performed at relatively high intensity, and designed to improve 
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parameters of general physical fitness and performance (13). In recent years HIFT has gained 
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increasing attention in the fitness industry and in research (14), especially due to the increased 
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popularity of the HIFT program CrossFit© (13). Recently trials, using HIFT protocols, have 
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reported benefits in healthy adults including physiological improvements such as increased oxygen 
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consumption, improved body composition and bone health (15,16).  
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One identified study by Heinrich et al examined the effectiveness and feasibility of 5 weeks of 
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HIFT among cancer survivors with a variety of cancer diagnoses. The study included 8 participants 
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and reported that the intervention was well-received, feasible and associated with a significant 
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improvement in emotional functioning and body composition. 
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HIFT is viewed as a promising type of training (13,17), that has shown numerous physiological 
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benefits (15,16,18) and has shown preliminary effectiveness and feasibility among cancer survivors 
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(17).  
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Furthermore, several reports and clinical guidelines recommend the prescription of exercise 
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programs that are enjoyable and facilitates social interactions, motivation and continued 
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participation to reduce risk of the development of comorbid conditions and late-appearing effects 
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of cancer and its treatment (1,8,19). HIFT has been reported to be associated with higher levels of 
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enjoyment than more traditional resistance training, and to facilitate adherence, continued 
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participation and sense of community among healthy participants (18,20). 
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Objective 
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The primary objective of this pragmatic clinical trial is to test the feasibility of the intervention in a 
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real world setting and secondary, to describe whether the HRQoL of the participants changes from 
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baseline to end-point and follow up time points. Furthermore, we will investigate the association 
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between the leisure-time HIFT and the HRQoL.  
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Methods: Participants interventions and outcomes 
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This study protocol is reported according to the Guidelines for Inclusion of Patient-Reported 
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Outcomes in Clinical Trial Protocols (SPIRIT-PRO) Extension.  
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Design and study setting 
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This study is a single group clinical trial. A pragmatic design will be applied for this study to 
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increase transferability, generalizability and the external validity of the results into clinical practise. 
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Thus, the clinical setting for the intervention will be at the municipality rehabilitation centre, Centre 
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for Cancer and Health Copenhagen (CCHC), in the capitol region of Denmark.  
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The exercise intervention will be implemented as a part of regular practice at the centre and will be 
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supervised by CCHC’s physiotherapists. Two co-authors of this protocol (MS and RD) are 
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employed as physiotherapists at CCHC. They have contributed in designing this study to fit the 
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clinical reality and the specific patient group at CCHC. This is another way increasing the external 
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validity of the results of this study, and to ‘bridge the gap’ between research and clinical practise. 
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This implementation of community-based clinicians in physiotherapy research has previously been 
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recommended in the literature (21,22).  
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Eligibility criteria 
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Due to the pragmatic design of this study, only few inclusion- and exclusion criteria will be applied. 
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Patients will be considered eligible for inclusion when they; 1) are at least 18 years old, 2) are 
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referred to the centre for cancer rehabilitation from any hospital or private practising general 
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practitioner in the Capital Region in Denmark, 3) Choosing to participate in group based high 
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intensity functional training that is offered at CCHC as part of their physical rehabilitation.  
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Eligibility for participation in this study will be regardless of cancer treatment and the stage of the 
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cancer. Thus, both patients undergoing active cancer treatment, patient who have completed active 
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treatment as well as chronic cancer survivors will be considered eligible for participation in this 
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study.  
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The following exclusion criteria will be applied for this study: 1) Not able to reply to the 
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questionnaire due to mental impairment, 2) Patients who are not able to read and understand 
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Danish, 3) Patients who does not have an e-mail address because of the application of online-based 
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questionnaires. 
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Intervention  
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The exercise intervention for this study will be HIFT, as defined by Feito et al and described in the 
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introduction of this study protocol (13). The program design and template will be based on the 
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principles of the HIFT program called CrossFit®. CrossFit is described as a strength and 
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conditioning program that focuses on “constantly varying functional movements, performed at a 
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relatively high intensity” (23). CrossFit training includes a variety of elements from gymnastics 
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(e.g., floor, bar and ring exercises), weightlifting exercises (e.g., squats, cleans, snatches and presses 
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with a barbell, dumbbell or kettlebell), and cardiovascular activities (e.g., running or rowing) (24). 
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All group training sessions will take place in a clinical setting at CCHC.  
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The full exercise protocol template is designed as a 38-week HIFT program, as the inclusion of 
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participants will be consecutive. All participants will complete 16 weeks of twice weekly group-
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based HIFT sessions, under the supervision of two physiotherapists, specifically trained to deliver 
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the HIFT program. Given the consecutive nature of this inclusion process, the participants will 
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initiate the group-based training at different dates between august 5th 2019 and January 5th 2019 (see 
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figure 2 for process of HIFT program implementation and figure 3 for timeline of the study period 
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with important dates). 
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Each training session will last for one hour and 15 minutes and will include a general warmup, a 
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strength-focused section including 1-3 exercises and a aerobic-focused workout.  
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The exercise program is not developed to include a general progression in terms of resistance, 
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intensity or volume over the cause of 38 weeks. An exercise compendium will be developed to meet 
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one of the key principles of CrossFit, that is scalability (25). The compendium will include 
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movement standards as well as progressions and regressions of all included exercises. This is to 
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assist the supervising physiotherapists in choosing the relevant level of intensity and exercise 
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difficulty for each participant, and to allow for individual progression over the cause of the 16-week 
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exercise intervention period for each participant.   
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Patient-reported outcomes 
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EORTC: 
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EORTC QLQ-C-30 includes five functional domains (physical, role, cognitive, emotional and 
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social, where higher scores represent greater function or quality of life) and three symptom scales 
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(fatigue, pain and nausea). Functional and symptom scales range from 0 to 100. Higher values on 
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functional scales equal a higher level of functioning. Higher values on symptom scales equal higher 
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symptom burden. EORTC QLQ-C-30 is chosen for it’s established reliability and validity with 
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specific emphasis on use in cancer populations (26, 27). 
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GLTEQ: 
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Leisure time physical activity (LTPA) will be assessed using an original Danish translation of the 
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Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) .The GSLTPAQ is 
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frequently used in oncology research to assess LTPA. 
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The GSLTPAQ is a 4-item self-administered questionnaire. The first three questions ask for 
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information on the number of times the respondant engages in mild, moderate and strenuous LTPA 
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bouts of at least 15 min duration in a typical week. A score is then calculated for total leisure time 
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based on the numerical values attributed to each of the three categories (9 for strenuous, 5 for 
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moderate and 3 for light) multiplied by the frequency of the activity. The scores derived from this 
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method is called a Leisure Score Index (LSI). In addition, scores obtained from moderate and 
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strenuous physical activity can be used to classify respondents into active and insufficiently active 
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categories.  
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A recently published systematic review by Amireault et al, supports the use of  the GSLTPAQ in 
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oncology research and the interpretation of the LSI for assessing relative change in PA among 
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cancer survivors.  
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Primary outcomes 
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HRQoL will be evaluated using the Global Health Status/Quality of Life item from the EORTC 
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QLQ-C-30 questionnaire. The item ranges from 0 to 100, and higher values equal higher HRQoL.  
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Time frame: for each participant at baseline + end point at 16 weeks + follow up at 3 month and 12 
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months)  
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Secondary outcomes 
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The secondary outcomes include functional scales (physical, role, emotional, cognitive, and social) 
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and symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, 
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constipation, diarrhea, and financial difficulties) from the EORTC QLQ-C30 questionnaire).  
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In addition to the EORTC QLQ-C30 scales, leisure-time exercise will be included as a secondary 
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outcome and will be assessed using the GSLTPAQ, including the frequency and duration of mild, 
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moderate and strenuous exercise. 
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[Time frame for each participant: Baseline + end point at 16 weeks + follow up at 3 months and 12 
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months] 
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Continued participation in any high intensity functional training (post-intervention HIFT) will be 
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assessed using a single-item modified version of the (GSLTPAQ) asking participants: During a 
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typical 7-Day period (a week), how many times on the average do you do High Intensity Functional 
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Training (I.E. CrossFit) for more than 15 minutes during your free time. The participant responds 
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by typing how many times per week, starting from zero.  
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[Time frame: for each participant at follow up at 3 month and 12 months] 
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Participation timeline  
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The inclusion of participants will be consecutive as patients are referred to CCHC for physical 
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cancer rehabilitation from various hospitals in the Capital Region in Denmark (see figure 1 for 
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participation flow of each participant).  
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Self-reported baseline data will be collected using online questionnaires sent out to patients via 
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email within four days prior to beginning the supervised HIFT intervention. After completing the 16 
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weeks of high intensity functional training the patient will receive an end point questionnaire. 
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Three months following completing the exercise intervention, participants will be contacted via 
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email to complete a follow-up questionnaire also including questions regarding continued 
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participation in HIFT. All participants will receive an identical follow-up questionnaire 12 month 
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after completing the intervention.   
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Sample size  
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Due to the exploratory nature of this study, no power calculation will be conducted. As the 
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inclusion of participants will be consecutive, the anticipated number of included participants will be 
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estimated based on the average monthly number of patients that begins the group based training 
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during clinical practise at the centre. The average number of patients who is referred to the 
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rehabilitation centre and who begins the HIFT training every month is 6 and thus, it is expected that 
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a total of approximately 30 participants will be included in this study during a 22-week consecutive 
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inclusion period that runs from august 5th 2019 to January 5th. All participants will be asked to 
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complete both baseline-, end point- and three-month follow-up assessment. 
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Recruitment 
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Due to the pragmatic design there will be no recruitment though advertisement. Recruitment will 
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take place by asking eligible patients referred to CCHC, if they would like to participate in the 
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study. This recruitment will take place during an initial rehabilitation planning session with a 
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physiotherapist two days prior to the first HIFT session. Patients will be made aware that they have 
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two days to consider participating in the study (written participant information can be found in 
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appendix 1).  
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Methods: Data collection, management and analysis 
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Data collection methods 
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Plan for assessment and collection of outcomes  
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All primary and secondary outcomes are participant-reported and will be administered through the 
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online survey tool: SurveyXact. All included participants will receive an email with an electronic 
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SurveyXact-invitation to the baseline questionnaire the same days as providing written consent to 
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participate in the study. On the day of the final HIFT session (week 16), the participants will receive 
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a similar SurveyXact-invitation with the end-point questionnaire. The three and 12-month follow up 
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assessments will be administered in identical ways to the end-point assessment.  
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Patient characteristics 
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Demographic variables will be included in the baseline questionnaire. These will include self-
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reported information about: sex, body mass index, educational level, employment, smoking status 
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and physical activity level, and will be collected together with information on cancer type, time 
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since cancer diagnosis, time since active treatment and cancer treatment type. 
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Registration of adverse events, plans to promote participant retention and complete follow 
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up: 
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Adverse events and reasons for drop out from discontinued participant will be collected by 
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practising physiotherapists at CCHC.   
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To minimize non-response and loss to follow-up participants will receive a reminder by email 4 and 
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14 days after receiving the email with end-point and follow-up questionnaire if they haven’t 
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provided their responses.  
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Data management  
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All outcomes will be handled and stored electronically on a secure server for personal data, located 
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at the University of Copenhagen.   
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No personal data will be exported from SurveyXact without pseudonymization. Complete 
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anonymization of all data will be done after the last follow up period. Data protection agency 
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approval Reference number: 514-0306/19-3000  
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Statistical methods  
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Descriptive statistics will be used to summarize patient characteristics including age, sex, cancer 
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diagnosis and type of treatment. Furthermore, leisure-time HIFT exercise and HRQoL at baseline 
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will be summarized using the GSLTPAQ LSI score and the EORTC QLQ-C30 GH score 
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respectively. Quantile Quantile plots and histograms will be used to evaluate distribution of 
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standardized residuals. Continous data with normally distributed standardized residuals will be 
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summarized using parametric statistics. Continous data with without normally distributed 
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standardized residuals will be summarized as ordinal data, using non-parametric statistics. 
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Categorical data will be summarized using frequencies and % of total.  
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The EORTC QLQ outcomes will be conducted according to the EORTC QLQ-C30 scoring manual 
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(ref fayes 2001). Numerical data for each outcome with normal distributed standardized residuals, 
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will be analysed from baseline to end-point with parametric statistics (paired t-test with equal 
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variance). Single-Factor Repeated Measures Design will be conducted with a repeated measures 
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one-way analysis of variance with four within subject time levels: baseline, end-point, three month 
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follow up, and 12-month follow up. Summary statistics will include mean and confidence intervals 
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for each outcome. 
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Numerical data for each outcome, without normal distributed standardized residuals, or ordinal data 
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will be analyzed from baseline to end-point with non-parametric statistics (Wilcoxon signed-ranks 
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test). Single-Factor Repeated Measures Design will be conducted with a Friedman two-way 
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analysis of variance by ranks with four within subject time levels: baseline, end-point, three months 
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follow up, and 12-month follow up. Summary statistics will include medians and interquartile 
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ranges for each outcome, and visualizations will include bar charts with confidence intervals.  
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The association between leisure-time HIFT exercise and HRQoL will be analyzed on each time 
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point with a linear regression model. To test whether the associations varies, the coefficients from 
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the linear regression analyses will be compared.  
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Stata 15.1 (StataCorp, College Station, TX, USA) will be used for all statistical analyses and 
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illustrations and an alpha level of 0.05 or less will be considered statistically significant.  
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Ethics and dissemination  
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The study will be performed according to the Declaration of Helsinki.  
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The Regional Scientific Ethics Committee of Capitol Region in Denmark has reviewed the outline 
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of this study. The committee waived the need for ethical approval as the intervention in the study is 
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a part of the regular practice at the CCHC. Thus, the committee proclaimed that the study included 
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“no or minimal health intervention”. Such studies can be implemented without permission from the 
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Ethics Committee according to Danish legislation (Committee Act § 2). 
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All included participants will provide written informed consent to participate in this study. 
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The study findings will be disseminated in peer reviewed journals and will be presented at national 
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conferences.  
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Locations 
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Center for Kræft og Sundhed København, Capital Region, Denmark, 2200 Copenhagen N. 
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Collaborators 
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Section of Social Medicine, Dept. of Public Health, Faculty of Health.University of Copenhagen.	 
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Gothersgade 160, 3. sal 
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1123 København K 
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Principal investigator 
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Andreas Lund Hessner 
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Authors contributions 
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ALH (principle investigator. ALH is the study coordinator and is responsible for, data collection, developing the 
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exercise intervention program and drafting of the manuscript. ALH and RT are responsible for data analysis. All 
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authors contributed to the design of the study. All authors will edit and approve the final manuscript. 
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Acknowledgements 
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No funds are present at current stage. 
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Abbreviations (In chronological order) 
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CS – Cancer Survivors 
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HRQoL – Health-related Quality of Life  
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CRF – Cancer-Related Fatigue 
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HIFT - High Intensity Functional Training 
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CKSK – Center for Kræft og Sundhed København (Center for Cancer and Health Copenhagen) 
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WOD – Workout of the Day 
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EORTC QLQ-C30 – European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 
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GLTEQ – Godin Leisure-time Exercise Questionnaire 
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Declarations of interests  
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ALH and RTL are both part time employees at the CrossFit affiliate CrossFit Copenhagen Aps. CrossFit Copenhagen 
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has supplied some additional exercise equipment for the intervention and offered the five supervising physiotherapists 
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from CCHC spots on their Trainers Course in order to develop and improve the physiotherapists HIFT-specific 
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instruction skills. ALH and RTL have not received any funds neither CrossFit Copenhagen or CCHC, nor will they 
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during the conduction of this study. The study is not a part of ALH and RTL’s occupation at CrossFit Copenhagen.  
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References  
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1.  
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Stefanelli F, Meoli I, Cobuccio R, Curcio C, Amore D, Casazza D, et al. High-
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pulmonary disease and non-small-cell lung cancer undergoing lobectomy. Eur J Cardiothorac Surg. 
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Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training 
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Appendices 
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Appendix 1 
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Information concerning participation in a scientific research study 
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Trial title:   
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High Intensity Functional Training in the rehabilitation of cancer survivors – A pragmatic 
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Intervention Study 
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We would like to ask you, if you would like to participate in a trial carried out at the Centre 
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for Cancer and Health Copenhagen. The research trial is conducted by the University of 
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Copenhagen and physiotherapist Andreas Lund Hessner. 
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Before you decide, whether you want to participate, you have to fully understand what the purpose 
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of the study and why it is being conducted. Therefore, we would like to ask you to read this 
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participant information thoroughly. 
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If you decide to participate in this study, we would like to ask you to sign a written consent 
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statement. We would like to remind you that you are allowed time to consider before you decide 
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whether you want to sign the written consent statement. 
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Participation in this study is voluntary. At any time, and without reason you have the right to 
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withdraw you consent. Withdrawing from participation in this study will not have any 
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consequences for your further treatment and rehabilitation. 
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Purpose 
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The purpose of this study is to investigate, whether 16 weeks of High intensity functional training 
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improves the health-related quality of health in cancer survivors. 
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There is only one intervention group in this study and no control-group. There is therefore no 
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randomization, and thus, all participants will complete 16 weeks of CrossFit-based exercise 
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supervised by physiotherapists. CrossFit is a strength and conditioning program, that incorporates 
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different exercise with both free weights and bodyweight movements. 
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Plan for study period 
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With your consent you agree to participate in 16-week weeks of group-based exercise including two 
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weekly exercise sessions.  
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Prior to starting the intervention, we are going to ask you to complete a questionnaire with 
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questions concerning cancer treatment, symptoms and physical activity level. 
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Immediately following 16-week intervention period you will receive another questionnaire. Three 
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and 12 months following completion of the intervention period we will ask you to complete two 
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identical questionnaires.   
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Following completion, the results of this trial will be published in scientific journals and will be 
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presented at national medical conferences. All your personal information in this study is 
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anonymised.  
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Your health information 
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All outcome in this study is going to be collected through questionnaires. This means that we will 
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only collect information about you through these electronic questionnaires. Thus, there will not be 
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collected information about you or your health from medical records of any kind. 
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If you consent to participate in this study, we will ask you for your e-mail address and as previously 
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stated you will be asked to complete a total of four questionnaires. If you consent to participate we 
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will in within the next two days send you the baseline questionnaire electronically.  
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We ask you to complete this questionnaire before your first High intensity functional training 
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session in the intervention.  
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Relevance and benefits of the study 
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You will contribute to new knowledge and insights concerning the physical rehabilitation of people 
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living with cancer, including the types of exercise, that might be beneficial for cancer survivors. 
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Potential side-effects, risks and complications 
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Non serious potential side-effects 
Serious  
Long term risks 
Side-effects 
Muscle and joint pain 
Potential passing discomfort during the 
exercise sessions such as shortness of breath 
or dizzyness  
None 
None 
 
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There may occur risks associated with this study, that we do not yet know about. We ask you to 
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notify us, if you are to experience any health problems or concerns, during your participation in the 
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study.  
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Exclusion or interruption of study 
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If the health personnel at Centre for Cancer and Health Copenhagen assess that there may be health 
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circumstances, which may imply that your continuation in this study may be associated with any 
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type of risk, your participation in this study will be terminated. In this case the health personal will 
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assist you in finding the best course of action.  
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Information about economic/financial conditions 
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No financial benefits are associated with your participation in this study. 
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Access to study results 
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One peer reviewed article will be published in a scientific journal, during the fall of 2020. 
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The results of this study will upon publication be communicated to various media and through the 
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website of Centre for Cancer and health Copenhagen.  
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We hope that you through this information have received adequate insights into what it entails to 
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participate in this study, and that you feel appropriately informed to make the decision whether to 
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participate. We ask you to read the attached amendment concerning ”subjects rights in health 
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scientific research projects”.  
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If you would like more information about the study, we recommend you to contact project leader  
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Andreas Lund Hessner  
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E-Mail: hessnerfysioterapi@gmail.com   
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Telephone: 51964161 
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Best regards, 
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Andreas Lund Hessner, PT, MSc.  
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