Clinical trial NCT05367076: Fitness to Aid the Brain and Cognitive Skills
Official title: Development of a Web-based Exercise Training Program for Brain Repair and Cognitive Recovery for Paediatric Brain Tumour Survivors in the Community: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Brain Tumor
Cognitive Impairment
Keywords: Exercise
Physical functioning
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will assess the feasibility of a pilot clinical trial of community-led aerobic exercise training for paediatric brain tumour survivors (PBTS) and the feasibility of a web-based platform to deliver this exercise training. It is hypothesized that 12 weeks of community-led exercise training will be feasible for PBTS and the web-based platform will be feasible to deliver exercise training by community-based instructors.

Detailed description: PBTS will complete 12 consecutive weeks of exercise training. Exercise training will involve 90-minute group sessions of aerobic activity 3 times/week with a 30-minute snack/reward time. The investigators anticipate participants will complete the exercise training program in cohorts, each comprised of a minimum of 3 and maximum of 10 participants. With a minimum of 3 participants per cohort, in order for us to achieve the investigators' goal of recruiting 30 participants, the investigators anticipate running approximately 7 cohorts. Participants will be assigned to a cohort based on proximity to session location and availability to attend sessions.

Site Description:

This is a single-site trial, as participants will be recruited from SickKids. Community-led exercise training will be delivered at various locations across the Greater Toronto and Hamilton Area (GTHA). Exercise training sessions will be conducted in partnership with Wellspring, a network of community support services across the GTHA for individuals diagnosed and treated for cancer. The investigators have developed a web-based platform for Fitness Trainers/Therapists (FTTs) to i) educate them on working with PBTS, ii) build exercise session plans, and iii) provide feedback on sessions and overall web-based platform functionality and usability. The web-based platform will allow the administration of community-led exercise training in any location. To test the feasibility of the web-based platform, the investigators will be administering exercise training in approximately 5 locations associated with Wellspring centres (and/or surrounding gymnasiums or outdoor space) and Wellspring FTTs.

Study Intervention Description:

Exercise training will consist of group sessions of aerobic exercise. Each session will include five (5) components:

1. Warm-up activities
2. Aerobic training activities
3. Group sports/games
4. Cool-down activities
5. Snack/reward time The goal of the intervention is to increase and maintain participants' heart rate for at least 30 minutes per session at a minimum of 80% of participants' peak heart rate achieved during a baseline fitness assessment. Increased heart rate will mainly take place during the aerobic circuit training and group sport/game components of each session. Heart rate will be measured using heart rate monitors.

Description of study population:

* Sample size: n = 40 (30 PBTS, 10 Healthy Controls)
* Age: 6-17 years
* Sex: males and females
* General health \[PBTS\]: Patients who have completed treatment for hemispheric or posterior fossa tumours and do not have severe neurological/motor dysfunction that would preclude safe participation in an exercise program
* General health \[Healthy Controls\]: Do not have neurological/motor dysfunction that would preclude safe participation in baseline assessment or have a prior history of neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability at time of enrollment
* Geographic location: Canada

Eligibility criteria: Inclusion Criteria:

1. Between 6 years and 17 years and 11 months of age at time of enrollment
2. Diagnosed with a brain tumour
3. 1 to 15 years between diagnosis and time of study enrollment
4. Medically stable (i.e. must be in remission) as determined by a permanent SickKids staff Neuro-Oncologist
5. Either declare English as their native language or have at least two years of schooling in English at the time of their first assessment
6. Have a parent or legal guardian willing to complete the Health and Quality of Life measures
7. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardians

Exclusion Criteria:

1. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate, interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
2. Diagnosed with a neurodevelopmental or neurological disorder, cerebral palsy, developmental delay or learning disability prior to initial brain tumour diagnosis that would preclude safe participation
3. Receiving palliative care
4. Require sedation for neuroimaging
5. Have ferrous metal implants (i.e. cochlear implant, braces, etc.)
6. Have a programmable shunt
7. Pregnant
8. Completed any prior cognitive rehabilitation intervention within three months of enrollment

Primary outcomes:
measure: Feasibility of the exercise program: The probability that 30 eligible patients will be recruited
timeFrame: 24 Months
measure: Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions
timeFrame: 24 weeks
measure: Feasibility of the exercise program: The probability that a recruited participant will complete all study procedures
timeFrame: 24 weeks
measure: Feasibility of the exercise program: The probability that instructors will adhere to the web-based platform to deliver exercise training
timeFrame: 24 weeks
measure: Feasibility of the exercise program: The probability that instructors will develop a therapeutic alliance with the participants
timeFrame: 24 weeks
measure: Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable
timeFrame: 24 weeks
measure: Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant
timeFrame: 24 weeks
measure: Feasibility of the web-based platform: The probability that instructors will rate the platform as efficient
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
measure: Comparison of community-led vs. historical hospital-led exercise training program: Changes in hippocampal volume
timeFrame: Baseline, Week 13, and Week 25
measure: Comparison of community-led vs. historical hospital-led exercise training program: Changes in neural communication
timeFrame: Baseline, Week 13, and Week 25
measure: Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in information processing speed
timeFrame: Baseline, Week 13, and Week 25
measure: Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in controlled attention
timeFrame: Baseline, Week 13, and Week 25
measure: Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in declarative memory
timeFrame: Baseline, Week 13, and Week 25
measure: Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in cardiovascular fitness (heart rate, and sub-maximal and maximal work rates)
timeFrame: Baseline, Week 13, and Week 25
measure: Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in physical functioning (bilateral coordination and balance, and running speed/agility and strength)
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in white matter microstructure
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in hippocampal volume
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in neural communication
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in information processing speed
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in controlled attention
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in declarative memory
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in full scale intelligence
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in MEG behavioural measures
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Health and QOL
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in cardiovascular fitness (heart rate, and sub-maximal and maximal work rates)
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in physical functioning (bilateral coordination and balance, and running speed/agility and strength, and ataxia)
timeFrame: Baseline, Week 13, and Week 25
measure: Impact of this study intervention on PBTS: Changes in physical functioning as reported by parent (PEDI-CAT)
timeFrame: week 25
measure: Comparing brain structure outcomes before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing brain function outcomes before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing cognitive outcomes (information processing speed) before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing cognitive outcomes (controlled attention) before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing cognitive outcomes (declarative memory) before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing cognitive outcomes (full scale intelligence quotient) before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing cognitive outcomes (MEG behavioral measures) before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing health outcomes before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
measure: Comparing quality of life outcomes before and after community-based exercise training to a group of healthy age-matched peers
timeFrame: Baseline
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Donald J Mabbott
role: PRINCIPAL_INVESTIGATOR
References: