Pediatric Brain Tumor
Conditions
Keywords
Pediatric Brain Tumor, Exercise Program, HIIT Program, Pediatric Brain Tumor Survivors
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.
Interventions
BEHAVIORALHIIT Exercise Program
Exercise program with stationary bike via the Zoom platform.
BEHAVIORALControl Group
Usual Activities
Sponsors
Dana-Farber Cancer Institute
Stahl Family Charitable Foundation
The Childhood Brain Tumor Foundation
Pedals For Pediatrics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent prior to any study-related procedures. * At time of study are a young adult, aged 18-45 years. * Histologically diagnosed brain tumor during childhood, or currently diagnosed with an IDH-mutant glioma (diagnosed \> 18 years). * Are at least 2 years post tumor-directed therapy for pediatric brain tumor survivors, or at least 1 year since their most recent surgery, radiation or chemotherapy treatment for IDH-mutant glioma patients (or are deemed able to participate in the study based on the assessment of their treating physician). IDH-mutant glioma patients can participate while on maintenance therapy with an IDH inhibitor. * The effects of exercise on the developing fetus are unknown. For this reason, people of child-bearing potential must verify pregnancy status by providing first day of their last menstrual cycle and agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry. Should a person become pregnant or suspect that they are pregnant while participating on the trial, they should inform their treating physician immediately. * Medically cleared to participate in exercise by their referring physician or a certified clinical exercise physiologist. * If participants have a diagnosis of tumor-related epilepsy, they must have good seizure control, with no generalized seizures in the 6 months preceding enrollment. * Are without any other 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 cigarettes or e-cigarettes (no smoking during the previous 12 months). Those who infrequently smoke in social settings will be included. Those who vape will also be included. * 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 tumor-related epilepsy, cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise. * Patients with evidence of progressive CNS or systemic cancer in the last 3 months. * People who are pregnant, or plan to become pregnant during study duration will be excluded due to the unknown nature of exercise on developing fetuses. * Actively on a weight loss diet. * Participate in more than 60 minutes of moderate or vigorous structured exercise/week. * Currently and regularly smokes. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attendance of Exercise Sessions | From first exercise session to final exercise session, up to 16 weeks | Defined as participant attendance of \>= 70% of the 48 HIIT exercise sessions. |
| Completion in Minutes of Exercise Sessions | From first exercise session to final exercise session, up to 16 weeks | Defined as participant completion of \>= 70% of the 90 minutes of exercise per week |
| HIIT Compliance | From first exercise session to final exercise session, up to 16 weeks | Defined as obtaining +-5W of target power output for \>= 40 seconds of high intensity minute |
| Barriers to Exercise Adherence | From first exercise session to final exercise session, up to 16 weeks | 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 | From first exercise session to final exercise session, up to 16 weeks | Assessed through the Perceived Research Burden Assessment (PRBA), 1-5 scale with 1 denoted as strongly disagree and 5 as strongly agree. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognition | : From baseline to post-intervention, up to 43 weeks | An assortment of tests will be executed through the NIH toolbox to measure overall cognition. |
| Cardiorespiratory Fitness | From baseline to post-intervention, up to 43 weeks | 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 | From baseline to post-intervention, up to 43 weeks | 10-repetition maximum will be used to assess muscular strength. |
| Body Composition | From baseline to post-intervention, up to 43 weeks | 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 | From baseline to post-intervention, up to 43 weeks | BFI: A questionnaire of scale ratings 0 - 10 that focuses on cancer-related fatigue and tiredness. |
| Psychosocial Health | From baseline to post-intervention, up to 43 weeks | 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 | From baseline to post-intervention, up to 43 weeks | 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 | Up to 3 days | 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 | From baseline to post-intervention, up to 27 weeks | 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 | From baseline to week 16, up to 32 weeks | 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 | From baseline to post-intervention, up to 43 weeks | 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 | From baseline to post-intervention, up to 43 weeks | Hip and waist circumference will be assessed and recorded in cm. |
Countries
United States
Contacts
CONTACTChristina Dieli-Conwright, PhD, MPH
PRINCIPAL_INVESTIGATORChristina Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Outcome results
None listed