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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • HIIT Exercise Program

    Behavioral

    Exercise program with stationary bike via the Zoom platform.

  • Control Group

    Behavioral

    Usual Activities

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: HIIT Exercise Program GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Attendance of Exercise Sessions

Defined as participant attendance of \>= 70% of the 48 HIIT exercise sessions.

Time frame
From first exercise session to final exercise session, up to 16 weeks
2

Completion in Minutes of Exercise Sessions

Defined as participant completion of \>= 70% of the 90 minutes of exercise per week

Time frame
From first exercise session to final exercise session, up to 16 weeks
3

HIIT Compliance

Defined as obtaining +-5W of target power output for \>= 40 seconds of high intensity minute

Time frame
From first exercise session to final exercise session, up to 16 weeks
4

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.

Time frame
From first exercise session to final exercise session, up to 16 weeks

Secondary outcomes

1

Cognition

An assortment of tests will be executed through the NIH toolbox to measure overall cognition.

Time frame
: From baseline to post-intervention, up to 43 weeks
2

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).

Time frame
From baseline to post-intervention, up to 43 weeks
3

Muscular Strength

10-repetition maximum will be used to assess muscular strength.

Time frame
From baseline to post-intervention, up to 43 weeks
4

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.

Time frame
From baseline to post-intervention, up to 43 weeks

Other outcomes

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