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Recruiting NCT05740839

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

No phase Interventional Pediatric Brain Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIIT Exercise Program, Control Group.
Who it may be relevant to
Registry conditions: Pediatric Brain Tumor. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Detailed 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.

Interventions

  • Behavioral HIIT Exercise Program
    Exercise program with stationary bike via the Zoom platform.
  • Behavioral Control Group
    Usual Activities

Primary outcome measures

  • Attendance of Exercise Sessions [Time frame: From first exercise session to final exercise session, up to 16 weeks]
  • Completion in Minutes of Exercise Sessions [Time frame: From first exercise session to final exercise session, up to 16 weeks]
  • HIIT Compliance [Time frame: From first exercise session to final exercise session, up to 16 weeks]
  • Barriers to Exercise Adherence [Time frame: From first exercise session to final exercise session, up to 16 weeks]
  • Participant Burden [Time frame: From first exercise session to final exercise session, up to 16 weeks]
Secondary outcome measures (12)
  • Cognition [Time frame: : From baseline to post-intervention, up to 43 weeks]
  • Cardiorespiratory Fitness [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Muscular Strength [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Body Composition [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Fatigue [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Psychosocial Health [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Quality of Sleep [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Dietary Assessment, ASA-24 [Time frame: Up to 3 days]
  • ActiGraph - Physical Activity Monitoring [Time frame: From baseline to post-intervention, up to 27 weeks]
  • Exercise Tolerance [Time frame: From baseline to week 16, up to 32 weeks]
  • Pain Index [Time frame: From baseline to post-intervention, up to 43 weeks]
  • Hip and Waist Circumference [Time frame: From baseline to post-intervention, up to 43 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT05740839 · 22-505

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗