Back to resultsHigh-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)
Primary Purpose
Pediatric Brain Tumor
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIIT Exercise Program
Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Pediatric Brain Tumor focused on measuring Pediatric Brain Tumor, Exercise Program, HIIT Program, Pediatric Brain Tumor Survivors
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.
Sites / Locations
- Dana Farber Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HIIT Exercise Program Group
Control Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Attendance of Exercise Sessions
Defined as participant attendance of >= 70% of the 48 HIIT exercise sessions.
Completion in Minutes of Exercise Sessions
Defined as participant completion of >= 70% of the 90 minutes of exercise per week
HIIT Compliance
Defined as obtaining +-5W of target power output for >= 40 seconds of high intensity minute
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.
Participant Burden
Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.
Secondary Outcome Measures
Cognition
An assortment of tests will be executed through the NIH toolbox to measure overall cognition.
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).
Muscular Strength
10-repetition maximum will be used to assess muscular strength.
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.
Fatigue
BFI: A questionnaire of scale ratings 0 - 10 that focuses on cancer-related fatigue and tiredness.
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
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.
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.
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.
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.
Pain Index
BPI: A 9 item questionnaire to evaluate the severity of pain and the impact of pain on the participant's daily functioning.
Hip and Waist Circumference
Hip and waist circumference will be assessed and recorded in cm.
Full Information
NCT ID
NCT05740839
First Posted
February 2, 2023
Last Updated
September 13, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Stahl Family Charitable Foundation, The Childhood Brain Tumor Foundation, Pedals For Pediatrics
1. Study Identification
Unique Protocol Identification Number
NCT05740839
Brief Title
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Acronym
HYPE
Official Title
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study (HYPE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Stahl Family Charitable Foundation, The Childhood Brain Tumor Foundation, Pedals For Pediatrics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Brain Tumor
Keywords
Pediatric Brain Tumor, Exercise Program, HIIT Program, Pediatric Brain Tumor Survivors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HIIT Exercise Program Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIIT Exercise Program
Other Intervention Name(s)
High-Intensity Interval Training
Intervention Description
Exercise program with stationary bike via the Zoom platform.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
Usual Activities
Primary Outcome Measure Information:
Title
Attendance of Exercise Sessions
Description
Defined as participant attendance of >= 70% of the 48 HIIT exercise sessions.
Time Frame
From first exercise session to final exercise session, up to 16 weeks
Title
Completion in Minutes of Exercise Sessions
Description
Defined as participant completion of >= 70% of the 90 minutes of exercise per week
Time Frame
From first exercise session to final exercise session, up to 16 weeks
Title
HIIT Compliance
Description
Defined as obtaining +-5W of target power output for >= 40 seconds of high intensity minute
Time Frame
From first exercise session to final exercise session, up to 16 weeks
Title
Barriers to Exercise Adherence
Description
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.
Time Frame
From first exercise session to final exercise session, up to 16 weeks
Title
Participant Burden
Description
Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree.
Time Frame
From first exercise session to final exercise session, up to 16 weeks
Secondary Outcome Measure Information:
Title
Cognition
Description
An assortment of tests will be executed through the NIH toolbox to measure overall cognition.
Time Frame
: From baseline to post-intervention, up to 43 weeks
Title
Cardiorespiratory Fitness
Description
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).
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Muscular Strength
Description
10-repetition maximum will be used to assess muscular strength.
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Body Composition
Description
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.
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Fatigue
Description
BFI: A questionnaire of scale ratings 0 - 10 that focuses on cancer-related fatigue and tiredness.
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Psychosocial Health
Description
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
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Quality of Sleep
Description
Assessed through the Pittsburg Sleep Quality Index (PSQI), which is used to measure 7 components of the quality and patterns of sleep in participants.
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Dietary Assessment, ASA-24
Description
Participants will be provided with a login to enter dietary data measured by an automated, online self-administered 24-hour assessment tool.
Time Frame
Up to 3 days
Title
ActiGraph - Physical Activity Monitoring
Description
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.
Time Frame
From baseline to post-intervention, up to 27 weeks
Title
Exercise Tolerance
Description
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.
Time Frame
From baseline to week 16, up to 32 weeks
Title
Pain Index
Description
BPI: A 9 item questionnaire to evaluate the severity of pain and the impact of pain on the participant's daily functioning.
Time Frame
From baseline to post-intervention, up to 43 weeks
Title
Hip and Waist Circumference
Description
Hip and waist circumference will be assessed and recorded in cm.
Time Frame
From baseline to post-intervention, up to 43 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Dieli-Conwright, PhD, MPH
Phone
617-582-8321
Email
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
We'll reach out to this number within 24 hrs