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HIIT Exercise for Brain Cancer Survivors (HYPE Trial)
N/A
Recruiting
Led By Christina Dieli-Conwright, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 16, up to 32 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether an exercise program can improve physical, mental and emotional health for young adult survivors of pediatric brain tumors.
Who is the study for?
This trial is for young adults aged 18-39 who survived pediatric brain tumors, are at least two years post-treatment, and currently do little structured exercise. They must be medically cleared for exercise, not smoke or vape, agree to use contraception if applicable, and be willing to travel for data collection. Those with uncontrolled diseases or active malignancies cannot join.
What is being tested?
The study tests a virtual 16-week high-intensity interval training (HIIT) program against a control group to see if it improves physical, cognitive, and emotional health in survivors of pediatric brain tumors.
What are the potential side effects?
While the trial does not involve medication with side effects typical of drugs, HIIT can cause muscle soreness, fatigue or injury especially if participants are not accustomed to intense physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 16, up to 32 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 16, up to 32 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Attendance of Exercise Sessions
Barriers to Exercise Adherence
Completion in Minutes of Exercise Sessions
+2 moreSecondary study objectives
ActiGraph - Physical Activity Monitoring
Body Composition
Cardiorespiratory Fitness
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HIIT Exercise Program GroupExperimental Treatment1 Intervention
Participants will be randomly assigned to the HIIT exercise group and receive:
* 3x weekly for 16 week home-based virtually supervised High-Intensity Interval Training.
* 16-week self-directed exercise follow up period.
* 3 On-site visits at Week 1, 18 and 34 for assement testing and completion of questionnaires
Group II: Control GroupActive Control1 Intervention
Participants will be randomly assigned to the HIIT waitlist control group and receive:
* Daily usual activities
* 2 On-site visits at Week 1, and 18 for assement testing and completion of questionnaires
* Option to complete 16 week, 3x weekly HIIT exercise program after initial 16 week period.
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Who is running the clinical trial?
Pedals For PediatricsUNKNOWN
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,207 Total Patients Enrolled
Stahl Family Charitable FoundationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor or a certified exercise expert has approved me for exercise.I have heart, lung, or metabolic conditions that worsen with exercise.It has been over 2 years since my last cancer treatment.I have been diagnosed with a primary tumor in my spinal cord.I can communicate in English or Spanish.I currently have an active cancer.I don't have health issues worsened by exercise, like severe bone disease or uncontrolled heart/lung problems.I agree to take a pregnancy test and use birth control during and 6 months after the study.I was diagnosed with a brain tumor as a child.I am between 18 and 39 years old.
Research Study Groups:
This trial has the following groups:- Group 1: HIIT Exercise Program Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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