Fitness to Aid the Brain and Cognitive Skills

Cognitive Impairment Clinical Trial

— Fit ABCS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05367076
• Other study ID #: 1000073462
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: October 6, 2025

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Donald J Mabbott, Ph.D.
• Phone: 416-813-7654
• Email: donald.mabbott[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 = 30 - Age: 6-17 years - Sex: males and females - General health: 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 - Geographic location: Canada

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 6, 2025
• Est. primary completion date: October 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Cognitive Impairment
• Pediatric Brain Tumor

Intervention

Behavioral:
• Web-based Aerobic Exercise Program
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: Warm-up activities Aerobic activities and fitness training in a game-like fashion Organized sports/games Cool down activity Snack/reward time

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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	24 weeks
Primary	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
Primary	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
Primary	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
Primary	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