To hear about similar clinical trials, please enter your email below
Trial Title:
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
NCT ID:
NCT05740839
Condition:
Pediatric Brain Tumor
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
Pediatric Brain Tumor
Exercise Program
HIIT Program
Pediatric Brain Tumor Survivors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
HIIT Exercise Program
Description:
Exercise program with stationary bike via the Zoom platform.
Arm group label:
HIIT Exercise Program Group
Other name:
High-Intensity Interval Training
Intervention type:
Behavioral
Intervention name:
Control Group
Description:
Usual Activities
Arm group label:
Control Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
39 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina M Dieli-Conwright, PhD, MPH
Phone:
617-632-3800
Email:
ChristinaM_Dieli-Conwright@dfci.harvard.edu
Contact backup:
Last name:
PhD, MPH
Investigator:
Last name:
Christina M Dieli-Conwright, PhD
Email:
Principal Investigator
Start date:
December 4, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Stahl Family Charitable Foundation
Agency class:
Other
Collaborator:
Agency:
The Childhood Brain Tumor Foundation
Agency class:
Other
Collaborator:
Agency:
Pedals For Pediatrics
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05740839
