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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Pediatric Brain Tumor
• Intervention / Treatment: Behavioral: HIIT Exercise Program; Behavioral: Control Group

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Dieli-Conwright, PhD, MPH; Phone Number: 617-582-8321; Email: ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Christina M Dieli-Conwright, PhD, MPH; Phone Number: 617-632-3800; Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
      • Contact: PhD, MPH
      • Principal Investigator: Christina M Dieli-Conwright, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: HIIT Exercise Program; Exercise program with stationary bike via the Zoom platform.; Other Names: High-Intensity Interval Training
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.	Behavioral: Control Group; Usual Activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance of Exercise Sessions	Defined as participant attendance of >= 70% of the 48 HIIT exercise sessions.	From first exercise session to final exercise session, up to 16 weeks
Completion in Minutes of Exercise Sessions	Defined as participant completion of >= 70% of the 90 minutes of exercise per week	From first exercise session to final exercise session, up to 16 weeks
HIIT Compliance	Defined as obtaining +-5W of target power output for >= 40 seconds of high intensity minute	From first exercise session to final exercise session, up to 16 weeks
Barriers to Exercise Adherence	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.	From first exercise session to final exercise session, up to 16 weeks
Participant Burden	Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.	From first exercise session to final exercise session, up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition	An assortment of tests will be executed through the NIH toolbox to measure overall cognition.	: From baseline to post-intervention, up to 43 weeks
Cardiorespiratory Fitness	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).	From baseline to post-intervention, up to 43 weeks
Muscular Strength	10-repetition maximum will be used to assess muscular strength.	From baseline to post-intervention, up to 43 weeks
Body Composition	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.	From baseline to post-intervention, up to 43 weeks
Fatigue	BFI: A questionnaire of scale ratings 0 - 10 that focuses on cancer-related fatigue and tiredness.	From baseline to post-intervention, up to 43 weeks
Psychosocial Health	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	From baseline to post-intervention, up to 43 weeks
Quality of Sleep	Assessed through the Pittsburg Sleep Quality Index (PSQI), which is used to measure 7 components of the quality and patterns of sleep in participants.	From baseline to post-intervention, up to 43 weeks
Dietary Assessment, ASA-24	Participants will be provided with a login to enter dietary data measured by an automated, online self-administered 24-hour assessment tool.	Up to 3 days
ActiGraph - Physical Activity Monitoring	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.	From baseline to post-intervention, up to 27 weeks
Exercise Tolerance	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.	From baseline to week 16, up to 32 weeks
Pain Index	BPI: A 9 item questionnaire to evaluate the severity of pain and the impact of pain on the participant's daily functioning.	From baseline to post-intervention, up to 43 weeks
Hip and Waist Circumference	Hip and waist circumference will be assessed and recorded in cm.	From baseline to post-intervention, up to 43 weeks

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Stahl Family Charitable Foundation; The Childhood Brain Tumor Foundation; Pedals For Pediatrics
• Investigators: Principal Investigator: Christina Dieli-Conwright, PhD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric Brain Tumor; Exercise Program; HIIT Program; Pediatric Brain Tumor Survivors
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 22-505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No