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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Pediatric Brain Tumor

Treatments: Behavioral: Control Group; Behavioral: HIIT Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05740839

22-505

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent prior to any study-related procedures.
• At time of study are a young adult, aged 18-39 years.
• Histologically diagnosed brain tumor during childhood (diagnosed ≤18 years).
• Are at least 2 years post tumor-directed therapy.
• The effects of exercise on the developing fetus are unknown. For this reason, women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
• Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist.
• Are without 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 or vape (no smoking/vaping during previous 12 months).
• Willing to travel to DFCI for necessary data collection.
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Diagnosis of primary spinal cord tumor.
• Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise.
• Patients with active malignancies.
• Patients who are pregnant.
• Actively on a weight loss diet.
• Participate in more than 60 minutes of moderate or vigorous structured exercise/week.
• Currently smokes or vapes.
• 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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

HIIT Exercise Program Group

Experimental group

Description:

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

Treatment:

Behavioral: HIIT Exercise Program

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control Group