Pediatric Brain TumorHYPENCT05740839
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
A study testing HIIT Exercise Program in people with Pediatric Brain Tumor, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a 16-week virtual, home-based, high-intensity interval training (HIIT) exercise program will improve physical, cognitive, and emotional health among young adult survivors of pediatric brain tumors. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Brain Tumor
- What is being tested?
- HIIT Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 24 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent prior to any study-related procedures.
- At time of study are a young adult, aged 18-45 years.
- Histologically diagnosed brain tumor during childhood, or currently diagnosed with an IDH-mutant glioma (diagnosed > 18 years).
- Are at least 2 years post tumor-directed therapy for pediatric brain tumor survivors, or at least 1 year since their most recent surgery, radiation or chemotherapy treatment for IDH-mutant glioma patients (or are deemed able to participate in the study based on the assessment of their treating physician). IDH-mutant glioma patients can participate while on maintenance therapy with an IDH inhibitor.
- The effects of exercise on the developing fetus are unknown. For this reason, people of child-bearing potential must verify pregnancy status by providing first day of their last menstrual cycle and agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry. Should a person become pregnant or suspect that they are pregnant while participating on the trial, they should inform their treating physician immediately.
- Medically cleared to participate in exercise by their referring physician or a certified clinical exercise physiologist.
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- If participants have a diagnosis of tumor-related epilepsy, they must have good seizure control, with no generalized seizures in the 6 months preceding enrollment.
- Are without any other medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases.
- Speak English and/or Spanish.
- Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week.
- Does not smoke cigarettes or e-cigarettes (no smoking during the previous 12 months). Those who infrequently smoke in social settings will be included. Those who vape will also be included.
- Willing to travel to DFCI for necessary data collection.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Diagnosis of primary spinal cord tumor.
- Pre-existing medical conditions such as uncontrolled tumor-related epilepsy, cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise.
- Patients with evidence of progressive CNS or systemic cancer in the last 3 months.
- People who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
- Actively on a weight loss diet.
- Participate in more than 60 minutes of moderate or vigorous structured exercise/week.
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- Currently and regularly smokes.
- Unable to travel to DFCI for necessary data collection.
- May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christina M Dieli-Conwright, PhD, MPH, 617-632-3800, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Christina M Dieli-Conwright, PhD
About this study
Official title: High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)
The purpose of this study is to determine whether a 16-week virtual, home-based, high-intensity interval training (HIIT) exercise program will improve physical, cognitive, and emotional health among young adult survivors of pediatric brain tumors.
The names of the study interventions involved in this study are/is:
- High-Intensity Interval Training (HIIT)
Read the detailed description
This is a Pilot/Feasibility, randomized control, research study that will compare an exercise group to a control group on physical, social, and overall quality of life needs of pediatric brain tumor survivors who are now young adults.
Participants will be randomized (selected at random) for two groups: HIIT program group will complete a 16-week intervention period followed by a 16-week period with no intervention and the waitlisted control group will complete a 16-week period and will perform their usual, daily activities followed by an optional 16-week period in which they can complete the HIIT program.
Research procedures include screening for eligibility, study treatment including in-clinic evaluations of fitness and strength, blood collection, at-home zoom exercise sessions, self-administered activity logs, and survey questionnaires.
Participation in this research study is expected to last about 8 months.
It is expected that about 30 people will take part in this research study.
The Stahl Family Charitable Foundation, Pedal 4 Pediatrics, and the Childhood Brain Tumor Foundation are supporting this research study by providing funding for the study.
- Conditions
- Pediatric Brain Tumor
- Being tested
- HIIT Exercise Program, Control Group
- Keywords
- Pediatric Brain Tumor, Exercise Program, HIIT Program, Pediatric Brain Tumor Survivors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT Exercise ProgramBehavioural
Also called High-Intensity Interval Training
Exercise program with stationary bike via the Zoom platform.
Control GroupBehavioural
Usual Activities
| Study group | Role | What they receive |
|---|---|---|
| HIIT Exercise Program Group | Experimental | 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 Receives: Behavioral: HIIT Exercise Program |
| Control Group | Active comparator | 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. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance of Exercise Sessions
Defined as participant attendance of >= 70% of the 48 HIIT exercise sessions.
Measured: From first exercise session to final exercise session, up to 16 weeks
Completion in Minutes of Exercise Sessions
Defined as participant completion of >= 70% of the 90 minutes of exercise per week
Measured: From first exercise session to final exercise session, up to 16 weeks
HIIT Compliance
Defined as obtaining +-5W of target power output for >= 40 seconds of high intensity minute
Measured: From first exercise session to final exercise session, up to 16 weeks
Barriers to Exercise Adherence
Assessed through the 17-item Barriers to Recruitment Participation Questionnaire (BRPQ), 1-5 scale with 1 denoted as strongly agree and 5 as strongly disagree.
Measured: From first exercise session to final exercise session, up to 16 weeks
Participant Burden
Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.
Measured: From first exercise session to final exercise session, up to 16 weeks
Secondary outcomes (12)
Cognition
An assortment of tests will be executed through the NIH toolbox to measure overall cognition.
Measured: : From baseline to post-intervention, up to 43 weeks
Cardiorespiratory Fitness
Assessed through the use of a VO2 max (or submaximal if equipment is unavailable) cycle exercise stress test (Parvo Medics TrueOne 2400; Sandy, UT, USA).
Measured: From baseline to post-intervention, up to 43 weeks
Muscular Strength
10-repetition maximum will be used to assess muscular strength.
Measured: From baseline to post-intervention, up to 43 weeks
Body Composition
Bioelectrical Impedance Analysis (BIA), and blood pressure as measured twice on both arms with a seated position with a minimum of 1-minute interval and the higher pressure will be recorded when there are differences.
BIA: Assessed via bioelectrical impedance using a validated device (Tanita 780, Arlington Heights, IL). Participants will be asked to remove their shoes and socks after which height will be taken using a stadiometer they will then proceed to move to the BIA and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight.
Measured: From baseline to post-intervention, up to 43 weeks
Fatigue
BFI: A questionnaire of scale ratings 0 - 10 that focuses on cancer-related fatigue and tiredness.
Measured: From baseline to post-intervention, up to 43 weeks
Psychosocial Health
Assessed through the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, which is comprised of 27 items with scale ratings validated to measure physical, emotional, social, and functional well-being of cancer patients and survivors
Measured: From baseline to post-intervention, up to 43 weeks
Quality of Sleep
Assessed through the Pittsburg Sleep Quality Index (PSQI), which is used to measure 7 components of the quality and patterns of sleep in participants.
Measured: From baseline to post-intervention, up to 43 weeks
Dietary Assessment, ASA-24
Participants will be provided with a login to enter dietary data measured by an automated, online self-administered 24-hour assessment tool.
Measured: Up to 3 days
ActiGraph - Physical Activity Monitoring
Participants will be provided with an accelerometer (ActiGraph, Pensacola, FL) to wear for seven days at baseline and post-intervention testing visits and will be instructed to wear the water-resistant accelerometer at all times except for when swimming or bathing. The device will record activity data and will be electronically transferred to a computer via USB cable at time of completion.
Measured: From baseline to post-intervention, up to 27 weeks
Exercise Tolerance
Will be recorded using the Exercise-Induced Feeling Inventory (EIF). Based on a 0-4 scale, it assesses the participant's feeling state change(s) post-exercise and is also used for the assessment of self-motivation to adhere to an exercise regimen. Participants will be asked to complete the inventory before and after each exercise session.
Measured: From baseline to week 16, up to 32 weeks
Pain Index
BPI: A 9 item questionnaire to evaluate the severity of pain and the impact of pain on the participant's daily functioning.
Measured: From baseline to post-intervention, up to 43 weeks
Hip and Waist Circumference
Hip and waist circumference will be assessed and recorded in cm.
Measured: From baseline to post-intervention, up to 43 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start4 Dec 2023
- Primary completion24 Sep 2027 (estimated)
- Study completion24 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stahl Family Charitable Foundation, The Childhood Brain Tumor Foundation, Pedals For Pediatrics
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740839
- Sponsor's protocol ID
- 22-505
- Acronym
- HYPE
- Status last verified
- Nov 2026
- First submitted
- 2 Feb 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)
- ClinicalTrials.gov ID
- NCT05740839
- Acronym / sponsor ID
- HYPE / 22-505
- Conditions
- Pediatric Brain Tumor
- Keywords
- Pediatric Brain Tumor, Exercise Program, HIIT Program, Pediatric Brain Tumor Survivors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Stahl Family Charitable Foundation, The Childhood Brain Tumor Foundation, Pedals For Pediatrics
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 24 Sep 2027 (estimated)
- Study completion
- 24 Sep 2028 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a 16-week virtual, home-based, high-intensity interval training (HIIT) exercise program will improve physical, cognitive, and emotional health among young adult survivors of pediatric brain tumors.
The names of the study interventions involved in this study are/is:
- High-Intensity Interval Training (HIIT)
Detailed description
This is a Pilot/Feasibility, randomized control, research study that will compare an exercise group to a control group on physical, social, and overall quality of life needs of pediatric brain tumor survivors who are now young adults.
Participants will be randomized (selected at random) for two groups: HIIT program group will complete a 16-week intervention period followed by a 16-week period with no intervention and the waitlisted control group will complete a 16-week period and will perform their usual, daily activities followed by an optional 16-week period in which they can complete the HIIT program.
Research procedures include screening for eligibility, study treatment including in-clinic evaluations of fitness and strength, blood collection, at-home zoom exercise sessions, self-administered activity logs, and survey questionnaires.
Participation in this research study is expected to last about 8 months.
It is expected that about 30 people will take part in this research study.
The Stahl Family Charitable Foundation, Pedal 4 Pediatrics, and the Childhood Brain Tumor Foundation are supporting this research study by providing funding for the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT Exercise Program Group | Experimental | Behavioral: HIIT Exercise ProgramParticipants 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 |
| Control Group | Active comparator | Behavioral: Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Written informed consent prior to any study-related procedures.
- At time of study are a young adult, aged 18-45 years.
- Histologically diagnosed brain tumor during childhood, or currently diagnosed with an IDH-mutant glioma (diagnosed > 18 years).
- Are at least 2 years post tumor-directed therapy for pediatric brain tumor survivors, or at least 1 year since their most recent surgery, radiation or chemotherapy treatment for IDH-mutant glioma patients (or are deemed able to participate in the study based on the assessment of their treating physician). IDH-mutant glioma patients can participate while on maintenance therapy with an IDH inhibitor.
- The effects of exercise on the developing fetus are unknown. For this reason, people of child-bearing potential must verify pregnancy status by providing first day of their last menstrual cycle and agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry. Should a person become pregnant or suspect that they are pregnant while participating on the trial, they should inform their treating physician immediately.
Key exclusion criteria (9 listed)
- Diagnosis of primary spinal cord tumor.
- Pre-existing medical conditions such as uncontrolled tumor-related epilepsy, cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise.
- Patients with evidence of progressive CNS or systemic cancer in the last 3 months.
- People who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses.
- Actively on a weight loss diet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT Exercise ProgramAlso: High-Intensity Interval TrainingExercise program with stationary bike via the Zoom platform. | Behavioural | HIIT Exercise Program Group |
| Control GroupUsual Activities | Behavioural | Control Group |
Primary outcome
Attendance of Exercise Sessions
Time frame: From first exercise session to final exercise session, up to 16 weeks
Defined as participant attendance of >= 70% of the 48 HIIT exercise sessions.
Completion in Minutes of Exercise Sessions
Time frame: From first exercise session to final exercise session, up to 16 weeks
Defined as participant completion of >= 70% of the 90 minutes of exercise per week
HIIT Compliance
Time frame: From first exercise session to final exercise session, up to 16 weeks
Defined as obtaining +-5W of target power output for >= 40 seconds of high intensity minute
Barriers to Exercise Adherence
Time frame: From first exercise session to final exercise session, up to 16 weeks
Assessed through the 17-item Barriers to Recruitment Participation Questionnaire (BRPQ), 1-5 scale with 1 denoted as strongly agree and 5 as strongly disagree.
Participant Burden
Time frame: From first exercise session to final exercise session, up to 16 weeks
Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.
12 secondary outcomes
Cognition
Time frame: : From baseline to post-intervention, up to 43 weeks
Cardiorespiratory Fitness
Time frame: From baseline to post-intervention, up to 43 weeks
Muscular Strength
Time frame: From baseline to post-intervention, up to 43 weeks
Body Composition
Time frame: From baseline to post-intervention, up to 43 weeks
Fatigue
Time frame: From baseline to post-intervention, up to 43 weeks
Psychosocial Health
Time frame: From baseline to post-intervention, up to 43 weeks
Quality of Sleep
Time frame: From baseline to post-intervention, up to 43 weeks
Dietary Assessment, ASA-24
Time frame: Up to 3 days
ActiGraph - Physical Activity Monitoring
Time frame: From baseline to post-intervention, up to 27 weeks
Exercise Tolerance
Time frame: From baseline to week 16, up to 32 weeks
Pain Index
Time frame: From baseline to post-intervention, up to 43 weeks
Hip and Waist Circumference
Time frame: From baseline to post-intervention, up to 43 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christina Dieli-Conwright, PhD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT Exercise Program in people with Pediatric Brain Tumor, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Dieli-Conwright, PhD, MPH (617-582-8321, ChristinaM_Dieli-Conwright@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance of Exercise Sessions (time frame: From first exercise session to final exercise session, up to 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.