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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.
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:
Description of study population:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FitABCS exercise | Experimental | Web-based community-led, 12-week exercise program |
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| FitABCS control | No Intervention | Healthy control |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web-based Aerobic Exercise Program | Behavioral | Community based FTTs will use a web-based platform to deliver a 12-week exercise training program (120-minute group sessions of aerobic activity 3 times/week). Each session will include:
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the exercise program: The probability that 30 eligible patients will be recruited | In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory patient recruitment. The goal is to recruit n=30 participants (≥25% probability) Measure: The Bayesian probability statistic that 30 eligible patients will be recruited | 24 Months |
| Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions | In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory participant attendance. The goal is for a participant to attend ≥60% of exercise training sessions (≥80% probability of participants). Measure: The Bayesian probability statistic that participants will rate the therapeutic alliance between participant/instructor as cooperative and collaborative. | 24 weeks |
| Feasibility of the exercise program: The probability that a recruited participant will complete all study procedures | In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory participant adherence to study procedures (neuroimaging, cognitive, health and quality of life (QOL), cardiovascular fitness and physical functioning assessments). The goal is for a recruited participant to complete all study procedures (≥80% probability). Measure: The Bayesian probability statistic that a recruited participant will complete all study procedures | 24 weeks |
| Feasibility of the exercise program: The probability that instructors will adhere to the web-based platform to deliver exercise training | In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory instructor adherence to deliver the program. The goal is for instructors to adhere to the web-based platform to deliver exercise training (≥80% probability). Measure: The Bayesian probability statistic that instructors will adhere to the web-based platform to deliver exercise training |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of community-led vs. historical hospital-led exercise training program: Changes in hippocampal volume | To compare community-led exercise training to historical data from a hospital-led exercise training for PBTS in terms of changes in hippocampal volume using MRI (magnetic resonance imaging). Measures: Anatomical T1 weighted MRI will acquire estimates of hippocampal volume | Baseline, Week 13, and Week 25 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donald J Mabbott | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| 24 weeks |
| Feasibility of the exercise program: The probability that instructors will develop a therapeutic alliance with the participants | In order to determine the feasibility of a 12 weeks of community-led exercise training for PBTS, there will be satisfactory rating by the participant of the therapeutic alliance between participants and instructors. The goal is for participants to have a cooperative and collaborative relationship with the instructors, as rated by the Therapeutic Alliance Scales for Children-Revised questionnaire. Measure: The Bayesian probability statistic that the therapeutic alliance between participant/instructor will be comparable across cohorts. | 24 weeks |
| Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable | In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as acceptable (e.g. would recommend to others, would continue to use). The goal is for instructors to rate the the platform as acceptable, indicating ease of use and satisfaction (≥80% probability). Measure: The Bayesian probability statistic that instructors will rate the platform as acceptable | 24 weeks |
| Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant | In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as relevant (e.g. includes all necessary components to administer an exercise program, would choose to use such a tool to deliver an exercise program).The goal is for the instructors to rate the platform as relevant, indicating the presence of necessary information (≥80% probability). Measure: The Bayesian probability statistic that instructors will rate the platform as relevant | 24 weeks |
| Feasibility of the web-based platform: The probability that instructors will rate the platform as efficient | In order to determine the feasibility of a web-based platform to be used by community-based FTTs to deliver exercise training to PBTS, instructors will rate the platform as efficient (e.g. is useful). The goal is for the instructors to rate the platform as efficient, indicating its usefulness (≥80% probability). Measure: The Bayesian probability statistic that instructors will rate the platform as efficient | 24 weeks |
| Comparison of community-led vs. historical hospital-led exercise training program: Changes in neural communication | To compare community-led exercise training to historical data from a hospital-led exercise training for PBTS in terms of changes in neural communication, as estimated by functional connectivity during magnetoencephalography (MEG) recording. Measures: The weighted phase lag index (wPLI) will be used to measure functional connectivity during MEG recording as an estimate of neural communication | Baseline, Week 13, and Week 25 |
| Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in information processing speed | To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in information processing speed. Measure: Scores on the Rapid Visual Information Processing subtest of the Cambridge Neuropsychological Test Automated Battery | Baseline, Week 13, and Week 25 |
| Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in controlled attention | To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in controlled attention. Measure: Scores on the Match to Sample Visual Search Task subtest of the Cambridge Neuropsychological Test Automated Battery | Baseline, Week 13, and Week 25 |
| Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in declarative memory | To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in declarative memory. Measures: Scores on the Delayed Matching to Sample Task subtest of the Cambridge Neuropsychological Test Automated Battery | Baseline, Week 13, and Week 25 |
| 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) | To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in cardiovascular fitness, including heart rate, sub-maximal and and maximal work rates. Measures: 6-Minute Walk Test and electrically braked cycle ergometer to measure heart rate, and sub-maximal and maximal pro-rated work rates | Baseline, Week 13, and Week 25 |
| 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) | To compare community-led exercise training to historical data from a hospital-led exercise training program for PBTS in terms of changes in physical functioning, including bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility). Measure: Bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility) using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Minimum points scored: 0, maximum points scored: 80; higher scores account for greater motor proficiency (better outcomes) | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in white matter microstructure | To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in white matter microstructure using diffusion kurtosis imaging (DKI) Measures: DKI will acquire kurtosis measures of water diffusion in the brain (mean, axial, radial kurtosis) | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in hippocampal volume | To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes hippocampal volume using Anatomical T1 MRI Measures: Hippocampal volume estimated using Anatomical T1 MRI | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in neural communication | To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in neural communication as estimated by functional connectivity during MEG recording. Measures: The wPLI will be used to measure functional connectivity during MEG recording as an estimate of neural communication | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in information processing speed | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in information processing speed. Measures: Scores on the Pattern Comparison Processing Speed Test subtest of the National Institutes of Health Toolbox and Reaction Time Task subtest RTI subtest of the Cambridge Neuropsychological Test Automated Battery | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in controlled attention | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in controlled attention Measures: Scores on the Flanker Inhibitory Control & Attention Task subtest of the National Institutes of Health Toolbox, and the Stop Signal Task, Rapid Visual Information Processing, and Match to Sample Visual Search subtests of the of the Cambridge Neuropsychological Test Automated Battery | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in declarative memory | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in declarative memory Measures: Scores on the Children's Auditory Verbal and Learning Test-2 or Rey Auditory Verbal Learning Test (for participants who will be 18 years of age at the time of study completion) and Delayed Matching to Sample subtest of the Cambridge Neuropsychological Test Automated Battery | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in full scale intelligence | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in full scale intelligence. Measures: Scores on the Vocabulary and Matrix Reasoning subtests of the Wechsler Abbreviated Scale of Intelligence-Second Edition | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in MEG behavioural measures | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in MEG behavioural measures. Measures: Reaction time and accuracy scores on the Simple and Choice Visual-Motor Reaction Time Task, and Multi-Source Interference Task during MEG recording | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Health and QOL | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in health and QOL Measure: Scores on the Patient-Reported Outcomes Measurement Information System - Global health 7+2, Pediatric Quality of Life Scale generic core scale, physical activity preference questionnaire and Habitual Physical Activity Scale. All health and QOL measures are parent-proxy reports. | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in cardiovascular fitness (heart rate, and sub-maximal and maximal work rates) | To investigate the impact of community-led exercise training on the following outcomes in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in cardiovascular fitness, including heart rate, sub-maximal and and maximal work rates. Measures: 6-Minute Walk Test and electrically braked cycle ergometer to measure heart rate, and sub-maximal and maximal pro-rated work rates | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in physical functioning (bilateral coordination and balance, and running speed/agility and strength, and ataxia) | To investigate the impact of community-led exercise training in PBTS to provide preliminary data for a subsequent adequately powered randomized controlled trial in terms of changes in physical functioning, including bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility), and ataxia. Measure: Bilateral coordination and balance (body coordination), and running speed/agility and strength (strength and agility) using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition. Minimum points scored: 0, maximum points scored: 80; higher scores account for greater motor proficiency (better outcomes), strength assessment conducted by a registered Physiotherapist and the Scale for the Assessment and Rating of Ataxia. Minimum points scored: 0, maximum points scored: 40; higher scores indicate increased severity of ataxia (worse outcome) | Baseline, Week 13, and Week 25 |
| Impact of this study intervention on PBTS: Changes in physical functioning as reported by parent (PEDI-CAT) | To investigate the impact of community-let exercise training in PBTS to improve physical functioning in the participant's daily life, as reported by their parent. Measure: Parent report the ease of physical (and cognitive) activities in their child's daily life. | week 25 |
| Comparing brain structure outcomes before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in brain structure following exercise training and at 3-month follow up compared to before exercise training. Measures: brain structure (MRI) as assessed through white matter microstructure as estimated by kurtosis (mean, axial, and radial). | Baseline |
| Comparing brain function outcomes before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in brain function following exercise training and at 3-month follow up compared to before exercise training. Measures: Hippocampal volume and functional connectivity (MEG) as estimated by the weighted Phase Lag Index (wPLI) | Baseline |
| Comparing cognitive outcomes (information processing speed) before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in cognition following exercise training and at 3-month follow up compared to before exercise training Measures: Pattern Comparison Processing Speed Test, Reaction Time (RTI) (reaction time for simple and 5-choice conditions= measured in milliseconds, shorter reaction time is better) | Baseline |
| Comparing cognitive outcomes (controlled attention) before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in cognition following exercise training and at 3-month follow up compared to before exercise training Measures: Flanker Inhibitory Control & attention Task, SST, RVP, and MTS) SST: Stop Signal Task (stop signal reaction time = milliseconds, lower is better) RVP: Rapid Visual information Processing (A prime = range 0-1, higher is better) MTS: Match To Sample visual search (correct trials (all trials) = %, higher is better) | Baseline |
| Comparing cognitive outcomes (declarative memory) before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in cognition following exercise training and at 3-month follow up compared to before exercise training Measures: CAVLT-2 or RAVLT, DMS CAVLT-2: Children's Auditory Verbal Learning Test 2 (standard scores range from <60 to >140, higher is better) RAVLT: Rey Auditory Verbal Learning Test (T scores range from < 20 to >80, higher is better) DMS: Delayed Matching to Sample (correct trials (all trials) = %, higher is better) | Baseline |
| Comparing cognitive outcomes (full scale intelligence quotient) before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in cognition following exercise training and at 3-month follow up compared to before exercise training Measures: 2 subtests (Vocabulary, Matrix Reasoning) where T-scores are computed (20-80 range) with a higher value denoting a better score. | Baseline |
| Comparing cognitive outcomes (MEG behavioral measures) before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in cognition following exercise training and at 3-month follow up compared to before exercise training Measures: Go/No-Go task, MSIT MSIT: Multi Source Interference Task (reaction time= milliseconds, lower is better; accuracy = /1, higher is better; this also applies to Go/No-Go) | Baseline |
| Comparing health outcomes before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in health and quality of life following exercise training and at 3-month follow- up compared to before exercise training. Measure: PROMIS parent proxy scale- Global health 7+2, PedsQL generic core parent-proxy report PROMIS: Patient-Reported Outcomes Measurement Information System (T-scores range 14.7-68.78, higher is better) PedsQL: Pediatric Quality of Life scale (range 0-100, higher score is better QoL) | Baseline |
| Comparing quality of life outcomes before and after community-based exercise training to a group of healthy age-matched peers | To investigate whether PBTS participants more closely resemble their healthy peers in health and quality of life following exercise training and at 3-month follow- up compared to before exercise training. Measure: HAES parent-proxy report, and PEDI-CAT HAES: Habitual Activity Estimation Scale (active hours = higher is better, inactive hours= lower is better) PEDI-CAT: pediatric evaluation of disability inventory computer adaptive test (scaled scores range 20-80, higher is better) | Baseline |