About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
HIIT Exercise Program
BehavioralExercise program with stationary bike via the Zoom platform.
Control Group
BehavioralUsual Activities
Treatment groups
Trial outcomes
Primary outcomes
Attendance of Exercise Sessions
Defined as participant attendance of \>= 70% of the 48 HIIT exercise sessions.
Completion in Minutes of Exercise Sessions
Defined as participant completion of \>= 70% of the 90 minutes of exercise per week
HIIT Compliance
Defined as obtaining +-5W of target power output for \>= 40 seconds of high intensity minute
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.
Secondary outcomes
Cognition
An assortment of tests will be executed through the NIH toolbox to measure overall cognition.
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).
Muscular Strength
10-repetition maximum will be used to assess muscular strength.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Stahl Family Charitable Foundation
Collaborator
The Childhood Brain Tumor Foundation
Collaborator
Pedals For Pediatrics
Collaborator