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

NCT05740839 | Recruiting

• 1 other identifier: 22-505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Pediatric Brain Tumor

Keywords

Pediatric Brain Tumor; Exercise Program; HIIT Program; Pediatric Brain Tumor Survivors

Outcome Measures

Primary Outcomes (5)

• Attendance of Exercise Sessions

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

  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

  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

  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.

  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.

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

Secondary Outcomes (12)

• Cognition

  : From baseline to post-intervention, up to 43 weeks

• Cardiorespiratory Fitness

  From baseline to post-intervention, up to 43 weeks

• Muscular Strength

  From baseline to post-intervention, up to 43 weeks

• Body Composition

  From baseline to post-intervention, up to 43 weeks

• Fatigue

  From baseline to post-intervention, up to 43 weeks

Study Arms (2)

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

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.

Behavioral: Control Group

Interventions

Control Group BEHAVIORAL

Usual Activities

Control Group

HIIT Exercise Program BEHAVIORAL

Exercise program with stationary bike via the Zoom platform.

Also known as: High-Intensity Interval Training

HIIT Exercise Program Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Pedals For Pediatrics: collaborator
• Stahl Family Charitable Foundation: collaborator
• The Childhood Brain Tumor Foundation: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Interventions

High-Intensity Interval Training; Control Groups

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Christina Dieli-Conwright, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, PhD, MPH

CONTACT

617-582-8321; ChristinaM_Dieli-Conwright@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 23, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): September 24, 2026
• Study Completion (Estimated): September 24, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)