Neoplasms

Nervous System Diseases

All Conditions

Rare Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Brain Tumor, Childhood

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

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.

Exercise program with stationary bike via the Zoom platform.

HIIT Exercise Program

Control Group

Christina Dieli-Conwright, PhD, MPH

Christina M Dieli-Conwright, PhD, MPH

PhD, MPH

Christina M Dieli-Conwright, PhD

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)

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.

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

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

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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

Defined as participant completion of \>= 70% of the 90 minutes of exercise per week

Defined as obtaining +-5W of target power output for \>= 40 seconds of high intensity minute

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.

Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.

An assortment of tests will be executed through the NIH toolbox to measure overall cognition.

Assessed through the use of a VO2 max (or submaximal if equipment is unavailable) cycle exercise stress test (Parvo Medics TrueOne 2400; Sandy, UT, USA).

10-repetition maximum will be used to assess muscular strength.

Bioelectrical Impedance Analysis (BIA), and blood pressure as measured twice on both arms with a seated position with a minimum of 1-minute interval and the higher pressure will be recorded when there are differences.

BIA: Assessed via bioelectrical impedance using a validated device (Tanita 780, Arlington Heights, IL). Participants will be asked to remove their shoes and socks after which height will be taken using a stadiometer they will then proceed to move to the BIA and stand still on the device while holding the handles with their hands at their sides. The device will estimate body fat using an algorithm based on their age, sex, height, and body weight.

BFI: A questionnaire of scale ratings 0 - 10 that focuses on cancer-related fatigue and tiredness.

Assessed through the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, which is comprised of 27 items with scale ratings validated to measure physical, emotional, social, and functional well-being of cancer patients and survivors

Assessed through the Pittsburg Sleep Quality Index (PSQI), which is used to measure 7 components of the quality and patterns of sleep in participants.

Participants will be provided with a login to enter dietary data measured by an automated, online self-administered 24-hour assessment tool.

Participants will be provided with an accelerometer (ActiGraph, Pensacola, FL) to wear for seven days at baseline and post-intervention testing visits and will be instructed to wear the water-resistant accelerometer at all times except for when swimming or bathing. The device will record activity data and will be electronically transferred to a computer via USB cable at time of completion.

Will be recorded using the Exercise-Induced Feeling Inventory (EIF). Based on a 0-4 scale, it assesses the participant's feeling state change(s) post-exercise and is also used for the assessment of self-motivation to adhere to an exercise regimen. Participants will be asked to complete the inventory before and after each exercise session.

BPI: A 9 item questionnaire to evaluate the severity of pain and the impact of pain on the participant's daily functioning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study	NCT05740839	Pediatric Brain...	HIIT Exercise P... Control Group	18 Years - 39 Years	Dana-Farber Cancer Institute
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study	NCT05740839	Pediatric Brain...	HIIT Exercise P... Control Group	18 Years - 39 Years	Dana-Farber Cancer Institute
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study	NCT05740839	Pediatric Brain...	HIIT Exercise P... Control Group	18 Years - 39 Years	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for hiit program

Every month we try and update this database with for hiit program cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.