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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 39 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05740839
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Dana-Farber Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Christina Dieli-Conwright, PhD, MPH
Principal Investigator Affiliation Dana-Farber Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pediatric Brain Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: HIIT Exercise Program Group

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

Active Comparator: Control Group

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.

Interventions

Behavioral: - HIIT Exercise Program

Exercise program with stationary bike via the Zoom platform.

Behavioral: - Control Group

Usual Activities

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Christina M Dieli-Conwright, PhD, MPH

[email protected]

617-632-3800

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