Improving Cardiorespiratory Fitness and Cardiometabolic Health Among Children With Physical Disabilities Through Movement-to-Music Telehealth With Arm-based Sprint-Intensity Interval Training
Phase: PHASE1
Conditions: Cerebral Palsy
Sponsor: University of Alabama at Birmingham

  
Arm-based Sprint-Intensity Interval Training Movement-to-Music (arm-SIT-M2M) for Children 
With Cerebral Palsy: A Pilot Feasibility Randomized Controlled Trial 
 
 
Study Protocol & Statistical Analysis Plan 
 
NCT05619211 
 
 
7 Nov 2025 
 
 
Byron Lai, Assistant Professor, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 
 
 

  
PILOTING MOVEMENT-TO-MUSIC WITH ARM-BASED SPRINT-INTENSITY 
INTERVAL TRAINING AMONG CHILDREN WITH PHYSICAL DISABILITIES 
 
Principal Investigator: Byron Lai, PhD 
Sponsor: University of Alabama at Birmingham 
National Clinical Trial (NCT) Identified Number:  NCT05619211 
 
Version Number:  v1.0 
7 Nov 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................. 1 
1 
PROTOCOL SUMMARY .................................................................................................... 1 
1.1 
Synopsis .................................................................................................................... 1 
1.2 
Schedule of Activities (SoA)....................................................................................... 2 
2 
INTRODUCTION ................................................................................................................ 3 
2.1 
Study Rationale ......................................................................................................... 3 
2.2 
Background ................................................................................................................ 3 
2.3 
Risk/Benefit Assessment ........................................................................................... 3 
2.3.1 
Known Potential Risks ............................................................................... 3 
2.3.2 
Known Potential Benefits ........................................................................... 3 
3 
STUDY DESIGN ................................................................................................................. 4 
3.1 
Overall Design ........................................................................................................... 4 
3.2 
End of Study Definition .............................................................................................. 4 
4 
STUDY POPULATION ....................................................................................................... 4 
4.1 
Inclusion Criteria ........................................................................................................ 4 
4.2 
Exclusion Criteria ....................................................................................................... 4 
4.3 
Screen Failures .......................................................................................................... 5 
4.4 
Strategies for Recruitment and Retention .................................................................. 5 
5 
STUDY INTERVENTION .................................................................................................... 5 
5.1 
Study Intervention(s) Administration .......................................................................... 5 
5.1.1 
Study Intervention Description ................................................................... 5 
5.1.2 
Dosing and Administration ......................................................................... 6 
5.2 
Measures to Minimize Bias: Randomization .............................................................. 6 
5.3 
Study Intervention Compliance .................................................................................. 6 
5.4 
Concomitant Therapy................................................................................................. 6 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL ........................................................................................... 6 
6.1 
Discontinuation of Study Intervention ........................................................................ 6 
6.2 
Subject Discontinuation/Withdrawal from the Study .................................................. 8 
6.3 
Lost to Follow-Up ....................................................................................................... 8 
7 
STUDY ASSESSMENTS AND PROCEDURES ................................................................. 8 
7.1 
STUDY Assessments ................................................................................................ 8 
7.2 
Adverse Events and Serious Adverse Events ........................................................... 8 
7.2.1 
Definition of Adverse Events (AE) ............................................................. 8 
7.2.2 
Definition of Serious Adverse Events (SAE) .............................................. 9 
7.2.3 
Classification of an Adverse Event ............................................................ 9 
7.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ........ 10 
7.2.5 
Adverse and serious adverse Event Reporting ....................................... 10 
7.3 
Unanticipated Problems ........................................................................................... 10 
7.3.1 
Definition of Unanticipated Problems (UP) .............................................. 10 
7.3.2 
Unanticipated Problem Reporting ............................................................ 11 
8 
STATISTICAL CONSIDERATIONS .................................................................................. 11 
8.1 
Statistical Hypotheses ............................................................................................. 11 

  
8.2 
Sample Size Determination ..................................................................................... 11 
8.3 
Statistical Analyses .................................................................................................. 12 
8.3.1 
General Approach.................................................................................... 12 
8.3.2 
Analysis of the Primary Efficacy Endpoint(s) ........................................... 13 
8.3.3 
Analysis of the Secondary Endpoint(s) .................................................... 13 
8.3.4 
Safety Analyses ....................................................................................... 13 
8.3.5 
Baseline Descriptive Statistics ................................................................. 13 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............. 13 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ....................................... 13 
9.1.1 
Informed Consent Process ...................................................................... 13 
9.1.2 
Study Discontinuation and Closure .......................................................... 14 
9.1.3 
Confidentiality and Privacy ...................................................................... 14 
9.1.4 
Quality Assurance and Quality Control .................................................... 15 
9.1.5 
Data Handling and Record Keeping ........................................................ 15 
9.1.6 
Protocol Deviations .................................................................................. 15 
9.1.7 
Conflict of Interest Policy ......................................................................... 15 
9.2 
Abbreviations ........................................................................................................... 16 
10 
REFERENCES ................................................................................................................. 17 
 

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STATEMENT OF COMPLIANCE 
The trial was conducted in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations 
(CFR). The Principal Investigator was assure that no deviation from, or changes to, the protocol 
was take place without prior documented approval from the Institutional Review Board (IRB), 
except where necessary to eliminate an immediate hazard(s) to the trial subjects. All personnel 
involved in the conduct of this study have completed Human Subjects Protection and ICH GCP 
Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials was 
submitted to the local Institutional Review Board (IRB) for review and approval. Approval of both 
the protocol and the consent form must be obtained before any subject was enrolled. Any 
amendment to the protocol was require review and approval by the IRB before the changes 
were implemented to the study. All changes to the consent form was IRB approved; a 
determination was made regarding whether a new consent needs to be obtained from subjects 
who provided consent, using a previously approved consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 SYNOPSIS  
Title: 
Arm-based Sprint-Intensity Interval Training Movement-to-Music 
(arm-SIT-M2M) for Children With Cerebral Palsy: A Pilot Feasibility 
Randomized Controlled Trial 
Study Description: 
This Phase I pilot randomized controlled trial tested the short-term 
effects of a 12-week home-based arm sprint-intensity interval 
training Movement-to-Music (arm-SIT-M2M) program among 
children with cerebral palsy. Parent–child dyads were randomized to 
either an immediate start intervention group or a 12-week waitlist 
control. Laboratory assessments were completed at baseline (week 
0) and post-intervention or post-wait period (week 13), with exercise 
delivered at home under synchronous telehealth supervision. 
Objectives: 
 
Aim 1: To examine the effects of arm-SIT-M2M on cardiorespiratory 
fitness compared with waitlist control. 
 
Aim 2: To explore effects of arm-SIT-M2M on indicators of 
cardiometabolic health. 
 
Aim 3: To evaluate feasibility, including adherence, enjoyment, 
recruitment, retention, and adverse events. 
Endpoints: 
Primary endpoint: Peak oxygen consumption (pVO₂) measured 
during graded arm-ergometer exercise testing. 
 
Secondary endpoints: Blood pressure; body composition from dual-
energy X-ray absorptiometry (DEXA); dried blood spot biomarkers 
including high-sensitivity C-reactive protein, hemoglobin A1c, fasting 
insulin, triglycerides, and total/LDL/HDL cholesterol. 
 

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Feasibility endpoints: Exercise adherence (YouTube analytics), 
physical activity enjoyment (PACES), technology issues, recruitment 
and attrition rates, and adverse events. 
Study Population: 
Fifty children with cerebral palsy (ages 6–17 years; Gross Motor 
Function Classification System levels I–III; physically inactive) and 
one caregiver per child. 
Phase: 
Phase I (pilot feasibility). 
Description of Study 
Intervention: 
Participants in the immediate start group completed seated, arm-
based sprint-intensity interval training synchronized to themed music 
videos three times per week for 12 weeks. Sessions were 
supervised in real time via a telehealth platform with chest-strap 
heart-rate monitoring and rating of perceived exertion–guided 
progression using resistance bands. Caregivers attended all 
sessions to support safety. Waitlist control participants maintained 
habitual activity for 12 weeks and then received the same 
intervention. 
Study Duration: 
The overall study spanned enrollment through completion of all post-
intervention assessments, with each dyad completing baseline and 
week-13 laboratory visits. 
Subject Duration: 
Approximately 13 weeks per participant, from baseline assessment 
to post-intervention or post-waitlist evaluation. 
 
 
1.2 SCHEDULE OF ACTIVITIES (SOA) 
 
Participants completed screening and baseline laboratory assessments at Week 0, including 
informed consent/assent, eligibility screening, demographics, questionnaires, blood pressure, 
DEXA, dried blood spot biomarkers, and graded arm-ergometer testing for peak oxygen 
consumption. Caregivers received CPR/AED and equipment training at baseline. 
 
During Weeks 1–12, participants randomized to the immediate start group completed 
supervised arm-based sprint-intensity interval training Movement-to-Music sessions three times 
per week via telehealth, with real-time heart rate monitoring and caregiver support. The waitlist 
control group maintained habitual activity during this period. Feasibility outcomes and adverse 
events were monitored continuously. 
 
At Week 13, all participants completed post-intervention or post-wait laboratory assessments 
identical to baseline, including questionnaires, blood pressure, DEXA, dried blood spot 
biomarkers, and graded exercise testing. Study equipment was returned at this visit. 
 
 

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2 
 
INTRODUCTION 
 
2.1 STUDY RATIONALE  
 
There are few evidence-based exercise options that children with cerebral palsy can utilize to 
improve their cardiorespiratory fitness and manage their cardiometabolic health. 
 
2.2 BACKGROUND  
 
Children with cerebral palsy (CwCP) have limited accessible exercise options that empower 
them to independently maintain their cardiorespiratory fitness, and this places them at high risk 
for mortality and numerous cardiometabolic complications across the lifespan. We developed an 
evidence-informed Movement-to-Music (M2M) program to improve cardiorespiratory fitness for 
children with mobility disabilities. The program includes 4 innovative components: 1) 
prerecorded videos with M2M exercises that are based on child-appropriate themes (e.g., 
superheroes, sports, pop music etc.); 2) replicable cloud-based tele-monitoring procedures; 3) 
behavioral tele-physical education supervision during exercise; and 4) sprint-intensity interval 
training (SIT) adapted for varying arm abilities. We aim to first pilot the health benefits and 
safety of the program among a cohort of children with CP, which inform the design of a scale-up 
trial that will include a broader group of children with mobility disabilities. 
 
2.3 RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
• 
Chest pain or discomfort 
• 
Heart palpitations 
• 
Rapid or irregular heartbeats 
• 
Unexplained wheezing 
• 
Shortness of breath 
• 
Fainting or near fainting 
• 
Lightheadedness or dizziness 
• 
Cardiac arrest for those who are severely deconditioned or are medically 
compromised 
 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Participation in regular exercise may have potential benefits towards health, but the benefits are 
not guaranteed. The study findings will help us understand the potential benefits of a telehealth 
arm-based Movement-to-Music program. The study findings will be used to inform a larger study 
that aims to improve cardiorespiratory fitness and cardiometabolic health among children with 
cerebral palsy.  
 
 
 

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3 
STUDY DESIGN  
 
3.1 OVERALL DESIGN 
  
This Completed Phase I pilot randomized controlled trial evaluates the safety, feasibility, and 
preliminary efficacy of a 12‑week home-based arm sprint‑intensity interval training 
Movement‑to‑Music (SIT‑M2M) program among children with cerebral palsy (ages 6–17, 
GMFCS I–III). Participants were randomized 1:1 to immediate intervention or waitlist control. 
Primary outcome was peak oxygen consumption (pVO2). Secondary outcomes included 
cardiometabolic indicators (DXA body composition, dried blood spot biomarkers, and blood 
pressure). Feasibility metrics included adherence, enjoyment, recruitment, and adverse events.  
 
3.2 END OF STUDY DEFINITION 
 
Immediate start participants completed the study in 12 weeks. Waitlist control participants 
completed the study in 24 weeks. 
 
4 
STUDY POPULATION 
 
4.1 INCLUSION CRITERIA 
 
Eligible child participants will (Inclusion Criteria): 
-have a medical diagnosis of cerebral palsy, as determined by ICD-10 codes 
-aged 6-17 years old 
-a Gross Motor Function Classification System Level I-III (as determined via participant 
screening, explained in the protocol section below) 
-medical clearance to participate in high-intensity exercise from a physician (using the attached 
medical screening form and explained in the intervention safety, 
monitoring, and response plan) 
-access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer 
-a caregiver who will support and monitor the participant’s safety during the intervention and 
manage the child’s exercise schedule. 
 
Eligible caregivers will include parents or legal guardians of the child, who can commit sufficient 
time to support the child in their roles for the study and communicate 
in English. Caregivers who have complete blindness or deafness will be excluded from 
participation. 
 
4.2 EXCLUSION CRITERIA 
 
Exclusion Criteria: 
-physically active (defined as >150 minutes per week of self-reported moderate-to-vigorous 
intensity exercise in a typical week) 
-cannot use their arms for exercise 
-a Gross Motor Function Classification Level of IV-V 

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-complete blindness or deafness; 
-contraindications to exercise testing according to American College of Sports Medicine (ACSM) 
guidelines (Liguori and American College of Sports Medicine, 2020): 
recent significant change in the resting electrocardiogram suggesting significant ischemia; 
recent myocardial infarction (within 2 days) or other acute cardiac event 
unstable angina; uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic 
compromise; symptomatic severe aortic stenosis; uncontrolled symptomatic 
heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or 
pericarditis; suspected or known dissecting aneurysm; acute systematic 
infection accompanied by fever, body aches, or swollen lymph glands; low bone-mineral density 
of the spine (a z-score of </= to -3, indicative of high risk for fracture 
that could occur from torsion of spine, determined at baseline data collection via the DXA scan). 
Liguori G, American College of Sports Medicine. ACSM's guidelines for exercise testing and 
prescription. Lippincott Williams & Wilkins; 2020 Dec 3. 
-pregnant (due to radiation from a Dual Energy X-ray Absorptiometry [DEXA] scan) 
-uses a pacemaker (a pacemaker will compromise the readings of the heart rate monitor used in 
this study) 
-has not been seen by a physician within the last year 
-uses a g-tube 
4.3 SCREEN FAILURES 
 
Participants could have been withdrawn by the study team after enrollment, should a criteria not 
be noticed during screening. However, this did not occur. 
 
4.4 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Recruitment occurred through clinics through the Division of Pediatric Rehabilitation Medicine at 
the University of Alabama at Birmingham and Children’s of Alabama. 
 
 
5 
STUDY INTERVENTION 
 
5.1 STUDY INTERVENTION(S) ADMINISTRATION 
 
5.1.1 STUDY INTERVENTION DESCRIPTION 
 
The exercises were guided by videos that included 5 themes: 3 related to superheroes, pop 
music, or football. Each theme included 3 sequential videos that coincided with the rest periods 
(1 video for wk 1; 1 video for wks 2–4; and 1 video for wks 5–12), totaling 15 videos. CwCP 
were able to choose to exercise with any themed video that corresponded to their exercise 
week. Videos included music related to the video themes. Music tempo and volume coincided 
with sprint and recovery periods. During each session, participants watched the video on their 
computer and followed along with the exercises, while the coach supervised them through a 
web camera. Sprint training incorporated repetitive arm movements related to video themes 
(e.g., Spiderman videos included web shooting; football included arm running/passing). Videos 

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included CP-specific adaptations to enhance engagement, including verbal cues, visualized 
movement adaptations for hemiparesis, slow and repetitive instructions, positive reinforcement, 
a judgment-free atmosphere, and imagery. Videos were archived within a private YouTube 
playlist unique to each participant. This allowed watched video minutes to be objectively 
recorded by YouTube cloud-based analytics linked to each participant’s email address. WC 
participants were asked to maintain their habitual activity behavior for 12 weeks and then 
received the same program as those who did not wait before starting the program. All 
participants were asked to maintain their habitual diet and eating patterns for the 12-week 
period (immediate 12-week intervention or 12-week wait period). All sessions were supervised 
and monitored in real time via a custom-designed TeleRehab web platform. 
5.1.2 DOSING AND ADMINISTRATION 
 
The telecoach supported participants in maintaining maximal effort intensity by monitoring RPE 
and providing motivational support. Motivational strategies included positive verbal 
encouragement to bolster exercise confidence (i.e., self-efficacy) and performing the exercises 
with the participant to enhance learning through observation (i.e., vicarious learning). These 
strategies were informed by Social Cognitive Theory. To monitor exercise intensity, the 
telecoach asked participants how hard they were working after every change in song (~5 
minutes) throughout the session. If participants reported <18 RPE, coaches/caregivers provided 
positive verbal encouragement to enhance motivation. Post-session, participants reported an 
overall RPE for the entire bout to determine the need to progress the exercise through the 
addition of resistance bands. Since caregiver knowledge and attitude are determinants of 
participation, caregivers were asked to help manage the child’s exercise schedule. 
 
5.2 MEASURES TO MINIMIZE BIAS: RANDOMIZATION 
 
The randomization order was created by the project statistician and only the project coordinator 
had access to the order. The outcome assessor was blinded to randomization. 
 
5.3 STUDY INTERVENTION COMPLIANCE 
 
Compliance was measured by the percentage of sessions attended divided by those prescribed. 
Fidelity to the exercise intensity was maintained through telecoach encouragement during the 
intervention sessions. 
 
5.4 CONCOMITANT THERAPY 
 
Participants were asked to maintain their habitual daily activities, but were not explicitly 
instructed to refrain from participating in new treatments or therapies. 
 
 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
 
6.1 DISCONTINUATION OF STUDY INTERVENTION 
 

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Participants could withdraw or refrain from participating in an exercise session. Participants 
were allowed to schedule make-up sessions for missed sessions.  
 
 

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6.2 SUBJECT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Subjects were free to withdraw from participation in the study at any time upon request. 
An investigator could discontinue or withdraw a subject from the study for the following reasons: 
 
• 
Significant study intervention non-compliance  
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or 
situation occurred such that continued participation in the study would not be in the best 
interest of the subject 
 
6.3 LOST TO FOLLOW-UP 
• 
Before a participant was deemed lost to follow-up, the investigator or designee had to 
make strong effort to regain contact with the subject (where possible, 3 telephone calls 
or emails).  
• 
If the participant was still unreachable, he or she was considered to have withdrawn from 
the study with a primary reason of lost to follow-up. 
 
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 STUDY ASSESSMENTS  
 
Assessments were conducted at baseline and post-intervention (12 weeks), with select 
measures collected continuously throughout the intervention period. During each exercise 
session, heart rate was monitored in real time using a Bluetooth chest-worn heart rate monitor 
integrated with the TeleRehab platform. Session intensity was assessed using ratings of 
perceived exertion (RPE), collected approximately every 5 minutes (following each song 
change) and again at the end of each session to capture overall effort. These data informed 
individualized progression of exercise intensity, including the addition of resistance bands when 
indicated. 
 
Intervention adherence was objectively tracked via cloud-based video analytics, which recorded 
minutes of exercise video viewing for each participant through individualized private playlists. 
Telecoaches also documented session attendance, technical issues, and participant 
engagement. 
 
Participant safety and tolerance were monitored continuously through live videoconferencing, 
heart rate surveillance, and verbal check-ins. Caregivers assisted with scheduling and 
facilitating participation, and habitual diet and physical activity behaviors were maintained 
throughout the intervention or waitlist period. 
 
7.2 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
   
7.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 

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7.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) was considered “serious” if, in the view of either the investigator or 
sponsor, it results in any of the following outcomes: 
 
• 
Death 
• 
A life-threatening adverse event (of note, the term “life-threatening” refers to an event in 
which the subject was at risk of death at the time of the event, rather than to an event 
which hypothetically might have caused death if it were more severe) 
• 
inpatient hospitalization or prolongation of existing hospitalization 
• 
a persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• 
or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the subject and may require medical or surgical intervention to prevent one 
of the outcomes listed in this definition. Examples of such medical events included allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
 
7.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
7.2.3.1 SEVERITY OF EVENT 
For adverse events (AEs), the following guidelines was used to describe severity:  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the subject’s 
daily activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events were usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious.” 
 
7.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the 
clinician who examines and evaluates the subject based on temporal relationship and his/her 
clinical judgment. The degree of certainty about causality was graded using the categories 
below. In a clinical trial, the study product must always be suspect.  
 
• 
Related – The AE was known to occurred with the study intervention, there was a 
reasonable possibility that the study intervention caused the AE, or there was a temporal 
relationship between the study intervention and event. Reasonable possibility means 
that there was evidence to suggest a causal relationship between the study intervention 
and the AE. 
• 
Not Related – There was not a reasonable possibility that the administration of the study 
intervention caused the event, there was no temporal relationship between the study 
intervention and event onset, or an alternate etiology has been established. 
 

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7.2.3.3 EXPECTEDNESS  
The Principal Investigator was responsible for determining whether an adverse event (AE) was 
expected or unexpected.  An AE was considered unexpected if the nature, severity, or 
frequency of the event was not consistent with the risk information previously described for the 
study intervention. 
7.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND 
FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the 
attention of study personnel during study visits and interviews of a study subject presenting for 
medical care, or upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs was captured on 
the appropriate case report form. Information to be collected included event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those 
with the training and authority to make a diagnosis), and time of resolution/stabilization of the 
event. All AEs occurring while on study must be documented appropriately regardless of 
relationship. All AEs was followed to adequate resolution. 
 
Any medical condition that was present at the time that the subject was screened was 
considered as baseline and not reported as an AE. However, if the study subject’s condition 
deteriorates at any time during the study, it was recorded as an AE.  
 
Changes in the severity of an AE was documented to allow an assessment of the duration of the 
event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
 
 
7.2.5 ADVERSE AND SERIOUS ADVERSE EVENT REPORTING  
All serious adverse events must be reported to the IRB and NIH according to regulatory 
requirements. The Principal Investigator immediately reported any serious adverse event, 
whether or not considered study intervention related. 
 
7.3 UNANTICIPATED PROBLEMS 
 
7.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of 
the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that were described in the protocol-related documents, such as the Institutional Review 
Board (IRB)-approved research protocol and informed consent document; and (b) the 
characteristics of the subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means 
there was a reasonable possibility that the incident, experience, or outcome may have 
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• 
Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
7.3.2  UNANTICIPATED PROBLEM REPORTING  
The investigator reported unanticipated problems (UPs) to the reviewing Institutional Review 
Board (IRB). The UP report included the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or 
outcome represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been 
taken or were proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs was reported using the following timeline:   
 
• 
UPs that were serious adverse events (SAEs) was reported to the IRB within 10 working 
days of the investigator becoming aware of the event.  
• 
Any other UP was reported to the IRB within 10 working days of the investigator 
becoming aware of the problem.  
 
 
8 
STATISTICAL CONSIDERATIONS  
 
8.1 STATISTICAL HYPOTHESES 
 
 
Primary Hypothesis 
Children with cerebral palsy randomized to the immediate telehealth sprint interval training 
Movement-to-Music (SIT-M2M) group demonstrated significantly greater improvements in 
cardiorespiratory fitness (VO₂peak) from baseline to 12 weeks compared with the waitlist control 
group. 
 
Secondary Hypotheses 
Compared with waitlist controls, participants in the SIT-M2M group demonstrated greater 
improvements in cardiometabolic risk indicators (e.g., resting heart rate, body composition, and 
blood pressure) and higher exercise adherence and engagement across the intervention period. 
 
8.2 SAMPLE SIZE DETERMINATION 
 
A target sample size of 50 participants permits at least 20 in each of the two study groups at 12-
week follow-up after allowing for up to 20% dropout (in each arm). Power calculations were 
performed using nQuery, v. 8.7, for Aims 1 and 2, and SAS, v. 9.4, for Aim 3. For Aims 1 and 2, 
we will compare our baseline measurements with those obtained at 6 weeks and 12 weeks. We 
obtained estimates of the standard deviation (SD) for peak oxygen consumption (pVO2) of 7.11 
ml/kg/min (1), percent body fat (% BF) of 8.5% (2), total cholesterol (TC) of 27.3 mg/dL (3), 
systolic blood pressure (SBP) of 14.0 mmHg (3), and diastolic blood pressure (DBP) of 11.7 

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mmHg (3). With these assumptions and those of a two-sided two-group t-test, an alpha of 0.05, 
and 20 participants per group, we will have at least 80% power to detect between-group 
differences of at least 6.47 ml/kg/min in pVO2, 7.7% BF, 24.9 mg/dL in TC, 12.8 mmHg in SBP, 
and 10.7 mmHg in DBP as being statistically significant (at any time point); with the previous 
assumptions and those of a two-sided paired t-test, an alpha of 0.05, and 20 participants, we 
will have at least 80% power to detect within-group changes of at least 4.70 ml/kg/min in pVO2, 
5.6% BF, 18.1 mg/dL in TC, 9.3 mmHg in SBP, and 7.8 mmHg in DBP as being statistically 
significant (between any two time points). These estimates are conservative since we will be 
performing our statistical analyses using statistical methods that are more sophisticated than 
those that are mentioned here. For Aim 3, our pilot data indicate that adherence to the 
intervention will be 75%. For an adherence rate of 75%, and assuming 40 participants in total, 
with 20 per study arm, complete the study, the corresponding exact binomial 95% confidence 
intervals are (0.588, 0.873) and (0.509, 0.913). 
 
8.3 STATISTICAL ANALYSES 
 
8.3.1 GENERAL APPROACH 
 
For all aims, data analyses will follow intent-to-treat principles. Descriptive statistics will be 
obtained for study variables. The normality of data distribution of the continuous outcomes will 
first be confirmed using graphical techniques and tests of normality; continuous outcomes that 
deviate greatly from a normal distribution will adjusted (e.g., transformed) so that the data 
distribution approximates a normal distribution. All statistical tests will be two-sided. Differences 
will be considered significant at p<0.05. Statistical analysis will be performed using SAS 
software (version 9.4). Missing data that are not rectified through ongoing review of source 
documents may be managed with multiple imputation, and the influence of the missing data will 
be assessed with sensitivity analyses. For Aims 1 and 2, our primary method of analysis will be 
general linear mixed models techniques, such as mixed models repeated measures analyses, 
as there will be two study groups (SIT-M2M and WC) and three time points (baseline, 6 weeks, 
and 12 weeks). An appropriate structure for the covariance matrix (e.g., unstructured) will be 
selected for these models using the final data. Post hoc analyses will be performed using the 
Tukey-Kramer multiple comparisons test. These models will allow us to assess the between-
group effect, the within-group effect, and the group by time interaction. Covariates to be 
included in some models include age, sex, and GMFCS level. Analysis of categorical variables 
between groups will be performed using the chi-square test (or Fisher’s exact test if needed). 
Pairwise correlations between study parameters will be assessed using Pearson (or Spearman, 
if needed) correlation analysis. For Aim 3, we will calculate adherence rates, adverse events 
rates, and other rates of interest, and corresponding exact binomial 95% confidence intervals. 
These rates will be calculated overall and stratified by study group. Exploratory comparisons of 
rates between groups will be performed using the chi-square test (or Fisher’s exact test if 
needed). 
 
1. 
Balemans AC, Van Wely L, De Heer SJ, Van den Brink J, De Koning JJ, Becher JG, et 
al. Maximal aerobic and anaerobic exercise responses in children with cerebral palsy. Med Sci 
Sports Exerc. 2013;45(3):561-8. 
2. 
Finbråten AK, Martins C, Andersen GL, Skranes J, Brannsether B, Júlíusson PB, et al. 
Assessment of body composition in children with cerebral palsy: a cross‐sectional study in N 
orway. Dev Med Child Neurol. 2015;57(9):858-64. 

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3. 
Barja S, Le Roy C, Sepúlveda C, Guzmán ML, Olivarez M, Figueroa MJ. Obesity and 
cardio-metabolic risk factors among children and adolescents with cerebral palsy. Nutrición 
hospitalaria. 2020;37(4):685-91. 
 
 
8.3.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
Post-intervention at week 12. 
 
8.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
N/A 
 
8.3.4 SAFETY ANALYSES 
 
Safety was monitored throughout the 12-week period and was evaluated by the data safety 
monitoring board. 
 
8.3.5 BASELINE DESCRIPTIVE STATISTICS 
 
Comparisons of rates between groups will be performed using the chi-square test (or Fisher’s 
exact test if needed). 
 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
Digital consent was allowed for the first year of the study and was obtained through a secure-
online database (RedCap). In-person written consent was obtained for most participants and 
required signature of two copies, one for the participant to keep and one for the research team. 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS 
PROVIDED TO SUBJECTS 
Consent forms describing in detail the study intervention, study procedures, and risks were 
given to the subject and written documentation of informed consent was required prior to 
conducting study screening procedures. Assent forms were provided for children under the age 
of 13 years. 
 
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Written informed consent was obtained from each caregiver (parent or legal guardian), and 
written assent was obtained from each child participant prior to completion of any study-specific 
procedures. The informed consent and assent process was conducted by trained research staff 
during the baseline laboratory visit. 
 

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Caregivers and children were provided with IRB-approved consent and assent documents 
describing the study purpose, procedures, potential risks and benefits, alternatives to 
participation, confidentiality protections, and the voluntary nature of participation. Research staff 
reviewed all documents with participants in language appropriate to their level of understanding 
and answered all questions prior to enrollment. 
 
Participants were informed that participation was voluntary and that they could withdraw from 
the study at any time without penalty or loss of benefits. Caregivers were given adequate time to 
review the consent materials and were encouraged to discuss participation with family members 
before signing. Copies of signed consent and assent forms were provided to families for their 
records. 
 
Documentation of informed consent and assent was maintained in study records in accordance 
with Institutional Review Board requirements. No study procedures were initiated prior to 
completion of the consent and assent process. 
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study could have been temporarily suspended or prematurely terminated if there was 
sufficient reasonable cause.  Written notification, documenting the reason for study suspension 
or termination, was provided by the suspending or terminating party to regulatory authorities.  If 
the study was prematurely terminated or suspended, the Principal Investigator (PI) would 
promptly inform study subjects and the Institutional Review Board (IRB) and provide the 
reason(s) for the termination or suspension.   
  
Circumstances that may warrant termination or suspension include, but were not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Insufficient compliance to protocol requirements 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
9.1.3 CONFIDENTIALITY AND PRIVACY  
 
Subject confidentiality and privacy was strictly held in trust by the participating investigators and 
their staff. Therefore, the study protocol, documentation, data, and all other information 
generated was held in strict confidence. No information concerning the study or the data was 
released to any unauthorized third party without prior written approval of the Principal 
Investigator.  
 
All research activities was conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB) may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the subjects in this study.  
 
The study subject’s contact information was securely stored at each clinical site for internal use 
during the study. At the end of the study, all records must continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB and/or Institutional policies. 
 
 

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9.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 
 
The research team held monthly meetings for intervention fidelity checks. 
 
9.1.5 DATA HANDLING AND RECORD KEEPING  
 
All data analyses were conducted by the project statistician. Data were double checked by study 
staff for accuracy. 
 
9.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection was the responsibility of the clinical trial staff at the site under the supervision of 
the Principal Investigator. The Principal Investigator was responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
 
 
9.1.5.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 3 years after the completion of the study. 
These documents should be retained for a longer period, however, if required by local 
regulations.  
 
9.1.6 PROTOCOL DEVIATIONS  
A protocol deviation was any noncompliance with the clinical trial protocol requirements. The 
noncompliance may be either on the part of the subject, the investigator, or the study site staff. 
As a result of deviations, corrective actions were to be developed by the site and implemented 
promptly.  
 
These practices were consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It was the responsibility of the Principal Investigator to use continuous vigilance to identify and 
report deviations within 10 working days of identification of the protocol deviation.  Protocol 
deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The 
Principal Investigator was responsible for knowing and adhering to the reviewing IRB 
requirements.  
 
9.1.7 CONFLICT OF INTEREST POLICY 
 
Any actual or perceived conflict of interest of persons who have a role in the design, conduct, 
analysis, publication, or any aspect of this trial was disclosed.   
 
 

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9.2 ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LSMEANS 
Least-squares Means 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10 REFERENCES  
Alvarez‑Pitti J, et al. Blood pressure response to exercise in children and adolescents. Front 
Cardiovasc Med. 2022;9:1004508. 
Araujo‑Moura K, et al. Blood pressure measurement in pediatric populations: systematic review 
and meta‑analysis. Eur J Pediatr. 2021. 
Lai B, Rimmer J, Barstow B, Jovanov E, Bickel CS. Teleexercise for Persons With Spinal Cord 
Injury: A Mixed‑Methods Feasibility Case Series. JMIR Rehabil Assist Technol. 2016;3(2):e8. 
Liguori G; American College of Sports Medicine. ACSM’s Guidelines for Exercise Testing and 
Prescription. Philadelphia: Lippincott Williams & Wilkins; 2020. 
Thompson WP, Gordon N; American College of Sports Medicine. Guidelines for Exercise 
Testing and Prescription. Philadelphia: Wolters Kluwer Health/Lippincott Williams & Wilkins; 
2010. 
Flynn JT, Kaelber DC, Baker‑Smith CM, et al. Clinical Practice Guideline for Screening and 
Management of High Blood Pressure in Children and Adolescents. Pediatrics. 
2017;140(3):e20171904.