Effects of a Metronome on Functional Outcomes in Aquatic Therapy
Phase: NA
Conditions: Exercise Therapy
Sponsor: Aultman Health Foundation

 
 
 
EFFECTS OF A 
METRONOME ON 
FUNCTIONAL 
OUTCCOMES IN AQUATIC 
THERAPY 
VERSION NUMBER: 5    VERSION DATE: 11/14/2018 
 
ID# AultmanRA2018.10.AF 
 
NCT number:  NCT03801772 
PRINCIPAL INVESTIGATOR: 
Andrew Daniel Fomich 
Physical Therapy - Aultman Tusc 
330-363-6215 
      Dan.Fomich@aultman.com 
 
 

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PROTOCOL TITLE:   Effects of a Metronome on Functional Outcomes in Aquatic Therapy 
 
PRINCIPAL INVESTIGATOR: 
Andrew Daniel Fomich 
Physical Therapy - Aultman Tusc 
330-363-6215 
      Dan.Fomich@aultman.com 
VERSION NUMBER: 5 
 
VERSION DATE: 11/14/2018 
 
 
1.0 
BACKGROUND INFORMATION AND RATIONALE 
○ Introduction 
           Physical therapy patients experiencing musculoskeletal pain often lack effort and consistency 
when performing aquatic exercises.  Studies have shown that the use of acoustic stimuli, 
such as music and the beeps of a metronome, improve performance and efficiency in 
runners.  However, it has not been determined if the use of a metronome can improve the 
outcomes of patients participating in aquatic physical therapy.  
 
○ Relevant Literature and Data 
      
In 2012, one of two adults in the United States were diagnosed with musculoskeletal  
conditions. In the same year, 25.5 million people lost an average of 11.4 days of work due to 
back and neck pain. (1)  
The benefits of aquatic therapy make it well suited for the treatment of musculoskeletal 
conditions. These benefits include decreased weight bearing, the thermal and compressive 
effects of water on the body, and less cardiovascular stress during exercise. (2) 
 In a 2008 study it was demonstrated that the use of acoustic pacing device can improve 
consistency and performance during and between exercise sessions in an aquatic environment 
among runners(3)  Studies have also shown that an aquatic exercise program can improve 
strength and function among varied age groups.(4,5) However, what isn’t known is if the use of 
an acoustic pacing device, such as a metronome, can improve the outcomes of patients in an 
aquatic therapy program.  
 
 
STUDY OBJECTIVES 
○ Primary Objective 
To determine if the use of a metronome improves measures of functional   
outcome in aquatic therapy. 
 
 
 
2.0 
INVESTIGATION PLAN 
○ General Schema of Study Design  
            Quasi-experimental 

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○ Study Duration, Enrollment and Number of Sites 
2.○.1 Date Range of Study 
(January 3, 2019 - December 1st, 2019) 
 
2.○.2 Total Number of Study Sites 
Aultman Tusc Therapy 
 
2.○.3 Total Number of Subjects Projected   120   
 
 
The statistician projected the study would require 102 
participants. I will recruit up to 120 to allow for unforeseen issues. The 
120 participants will be divided into a control group of approximately 60 
and the metronome group of approximately 60.  
 
 
 
○ Study Population 
2.○.1 Inclusion/Exclusion Criteria 
                    All patients over the age of 18 will be included in the study 
except for those that have identified themselves as being pregnant 
on intake, and those that are unable to hear the metronome or 
unable to hear it when their hearing aide is removed during 
treatment.  
 
 
  
STUDY PROCEDURES 
○ Procedures Involved 
During their initial evaluations and again at re-evaluation or discharge, patients will be 
assessed using a 30 second sit to stand.  The patient will be asked to rate their progress using 
the global rating of change scale at re-evaluation or discharge. The patients will be asked to 
rate their pain using a numerical pain scale. Their reported pain level will be recorded before 
and after each treatment. The number reported on initial evaluation and at discharge will be 
used in the study.   The above numbers will be recorded in the patient’s electronic chart and on 
the de-identified flow sheet.  All patients will be educated on proper performance of aquatic 
exercises following normal physical therapy procedures. The patients will be randomly placed 
into two groups:  a control group and a group exercising with the pacing of a metronome. (The 
metronome does not appear in the FDA’s product classification database as a medical device.)  
The patient’s will be randomized by placing 20 poker chips in a bag. There will be 10 white 
pieces with the letter C and 10 red pieces with the letter M.  When a patient is chosen for the 
study a piece of paper will be drawn out of the bag and they will be assigned to a group by the 
letter chosen. The bag will be refilled and the process repeated until the study groups are filled.  
                     The two groups will follow exercise protocols based on their diagnosis.  Each 
session will last approximately 30 to 45 minutes. The length of each treatment will be recorded 
on the flow sheet. The BORG scale (a valid, subjective measure of perceived exertion) will be 
used as a monitoring device to ensure that a desired level of exercise intensity is reached. The 
desired level is a score between 12 and 16. The patients will be asked to rate their level of 
exertion at the end of each session. Intensity of the exercises will be adjusted the next session 
if the patient’s reported level of exertion does not fall within the desired range.  The pain rating, 
noted above, and the BORG number will be recorded for both groups in the chart and flow 

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sheet as will be the metronome beats per minute for the study group. The beats per minute of 
the metronome will be adjusted to the patient’s pain free exertion level.  Patients in both 
groups will start with 10-20 repetitions of the exercises depending on their physical ability. The 
repetitions will be progressed as the patient’s strength and endurance improve and noted in the 
chart and the flow sheet.  
  The patients in the metronome group will have the metronome synchronized as 
previously noted on their second aquatic therapy treatment.  The beats per minute (BPM) will 
be increased on the metronome during the series of treatments until the patient can no longer 
maintain proper technique with the exercises.  The patient will be cued to keep pace with the 
beat of the metronome during the duration of the exercise.  
 
 
 
○ Visit Schedule 
            Each individual will participate in the study for the duration of their physical therapy 
plan of care, typically 10 to 12 visits. Enrollment will be on going during the study 
period in order to recruit the needed number of participants. Estimated completion 
date will be May 1st, 2019.  
 
○ Recruitment Procedures 
Participants will be recruited during their initial physical therapy evaluations. The 
study will be explained to them and the consent forms will be signed during their 
first aquatic therapy treatment.   
 
○ Data Collection and Management  
2.○.1 Data sources 
                               Participant’s initial evaluation will be used to determine age, gender and  
                               diagnosis.   
                                                                                                        
2.○.2 Data Elements to be Abstracted 
●  Numerical pain scale rating 
● 30 second sit to stand  
● BORG (perceived rating of exertion) 
● Global Rating of Change (GRoC) 
 
3.0 
STUDY ADMINISTRATION 
○ Data Quality.   Data collection in the pool will be limited to two Physical Therapist 
Assistants.  There will be 1- 4 Physical Therapist collecting data during the initial 
evaluation and re-evaluation depending on which PT is referring the patient for 
aquatic therapy.  
 
 
 
Privacy  and Confidentiality 
 
 
 
 
 
 
 
 
 
 
 
○ All laws ensuring privacy and confidentiality governed through HIPPA will continue to 
be practiced. 
○ Data with patient identifiers will be de-identified by me. 
○ All files will be stored in a secured and locked location at Aultman Tusc Therapy. 

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○ Confidentiality 
See above 
 
○ Regulatory and Ethical Considerations 
3.○.1 Risk Assessment   
 The participants in the study will face no additional risk than those not in 
the study. As normal physical therapy procedures will be followed for 
patients receiving aquatic therapy.  
 
 
3.○.2 Potential Benefits of Study Participation   
 
Anticipated benefits of participation in the study will be a decrease 
in the number of visits needed to improve strength and function.  
 
3.○.3 Informed Consent/Assent and HIPAA Authorization   
Informed consent will be obtained by the primary/secondary 
investigators during the patient’s first aquatic therapy treatment. No data 
will be collected until that point.   
 
3.○.3.1 
Waiver or Alteration of Consent (requesting a waiver) 
 
                                                   N/A 
 
 
3.○.3.2 
Waiver of HIPAA Authorization 
                                   N/A 
 
4.0 
SAFETY MANAGEMENT 
○ Adverse Events Collection/Reporting 
           Non-invasive use of a metronome 
 
○ Data Safety Monitoring Plan 
           Physical therapy guidelines are already in place to ensure  
           data safety of the patient participating in physical therapy treatment.  
 
5.0 
STATISTICAL CONSIDERATIONS 
○ Primary and Secondary Endpoints 
To determine if the use of a metronome increases intensity of exercise performance 
as measured by an increase in the BORG scale.  
To determine if the use of a metronome improves self-reported and objective 
measures of functional outcome performance by using the GROC and the 30 second 
sit to stand and noting an improvement in scores.  
 
 
○ Measures to Avoid Bias 

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Study participants will be randomized as previously noted.  
 
Statistical Methods, Sample Size and Power  
 
A minimum of 102 participants will be needed for a medium effect, a power of 0.8 and   
a level of significance of 0.05. The data analysis plan will be an Analysis of Covariance 
(ANCOVA), with the baseline data as the covariate.  
 
6.0 
PUBLICATION 
  Yes 
 
7.0 
REFERENCES 
1.  Bone and Joint Initiative USA 2016.  The Impact of Musculoskeletal Disorders on         
Americans - Opportunities for Action. 
http://www.Boneandjointburden.org/docs/BMUSExecutiveSummary2016.pdf 
2.  Becker BE, Aquatic therapy: Scientific Foundations and Clinical Rehabilitation Applications.   
PM R. 2009 Sept; 1(9): 859-72 
3.  Colado JC, Tella V, Triplett NT, A Method for Monitoring Intensity During Aquatic Exercises. J 
Strength Cond Res. 2008 Nov;22(6):2045-9 
4.  Kieffer HS, Lehman MA, Veacock D, Korkuch L, The Effects of a Short-Term Aquatic Exercise 
Program on Functional Strength and Performance of Older Adults. Int J Exerc Sci 2012, Oct 15; 
5(4): 321-333, Ecollection 2012 
5.  Poyhonen T, Sipila S, Keskinen K, Hautala A, Savolainen J, Malkia E, Effects of Aquatic 
Resistance Training on Neuromuscular Performance in Healthy Women. Med Sci Sport Exerc 
2002 Dec; 34(12) 2103-9