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High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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. The names of the study interventions involved in this study are/is: * High-Intensity Interval Training (HIIT)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
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• 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.

• 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

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Christina Dieli-Conwright, PhD, MPH
ChristinaM_Dieli-Conwright@dfci.harvard.edu
617-582-8321
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2027-09-24
Participants
Target number of participants: 30
Treatments
Experimental: HIIT Exercise Program Group
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
Active_comparator: Control Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Pedals For Pediatrics, The Childhood Brain Tumor Foundation, Stahl Family Charitable Foundation
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov