Clinical trial NCT05740839: High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Official title: High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Brain Tumor
Keywords: Pediatric Brain Tumor
Exercise Program
HIIT Program
Pediatric Brain Tumor Survivors
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Stahl Family Charitable Foundation
name: The Childhood Brain Tumor Foundation
name: Pedals For Pediatrics
First posted: 2023-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

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.

Eligibility 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.

Primary outcomes:
measure: Attendance of Exercise Sessions
timeFrame: From first exercise session to final exercise session, up to 16 weeks
measure: Completion in Minutes of Exercise Sessions
timeFrame: From first exercise session to final exercise session, up to 16 weeks
measure: HIIT Compliance
timeFrame: From first exercise session to final exercise session, up to 16 weeks
measure: Barriers to Exercise Adherence
timeFrame: From first exercise session to final exercise session, up to 16 weeks
measure: Participant Burden
timeFrame: From first exercise session to final exercise session, up to 16 weeks
Secondary outcomes:
measure: Cognition
timeFrame: : From baseline to post-intervention, up to 43 weeks
measure: Cardiorespiratory Fitness
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Muscular Strength
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Body Composition
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Fatigue
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Psychosocial Health
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Quality of Sleep
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Dietary Assessment, ASA-24
timeFrame: Up to 3 days
measure: ActiGraph - Physical Activity Monitoring
timeFrame: From baseline to post-intervention, up to 27 weeks
measure: Exercise Tolerance
timeFrame: From baseline to week 16, up to 32 weeks
measure: Pain Index
timeFrame: From baseline to post-intervention, up to 43 weeks
measure: Hip and Waist Circumference
timeFrame: From baseline to post-intervention, up to 43 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christina Dieli-Conwright, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: