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Fitness to Aid the Brain and Cognitive Skills (Fit ABCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05367076
Recruitment Status : Recruiting
First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
Donald Mabbott, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Pediatric Brain Tumor Cognitive Impairment Behavioral: Web-based Aerobic Exercise Program Not Applicable

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 4 and maximum of 10 participants. With a minimum of 4 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : October 6, 2023
Estimated Study Completion Date : October 6, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: FitABCS exercise
Web-based community-led, 12-week exercise program
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




Primary Outcome Measures :
  1. Feasibility of the exercise program: The probability that 30 eligible patients will be recruited [ Time Frame: 24 Months ]

    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


  2. Feasibility of the exercise program: The probability that a recruited participant will attend ≥60% of exercise training sessions [ Time Frame: 24 weeks ]

    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 a recruited participant will attend ≥60% of exercise training sessions


  3. Feasibility of the exercise program: The probability that a recruited participant will complete all study procedures [ Time Frame: 24 weeks ]

    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


  4. Feasibility of the exercise program: The probability that instructors will adhere to the web-based platform to deliver exercise training [ Time Frame: 24 weeks ]

    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


  5. Feasibility of the web-based platform: The probability that instructors will rate the platform as acceptable [ Time Frame: 24 weeks ]

    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


  6. Feasibility of the web-based platform: The probability that instructors will rate the platform as relevant [ Time Frame: 24 weeks ]

    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


  7. Feasibility of the web-based platform: The probability that instructors will rate the platform as efficient [ Time Frame: 24 weeks ]

    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



Other Outcome Measures:
  1. Comparison of community-led vs. historical hospital-led exercise training program: Changes in hippocampal volume [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  2. Comparison of community-led vs. historical hospital-led exercise training program: Changes in neural communication [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  3. Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in information processing speed [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  4. Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in controlled attention [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  5. Comparison of community-led exercise training to historical data from a hospital-led exercise training program: Changes in declarative memory [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  6. 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) [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  7. 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) [ Time Frame: Baseline, Week 13, and Week 25 ]

    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)


  8. Impact of this study intervention on PBTS: Changes in white matter microstructure [ Time Frame: Baseline, Week 13, and Week 25 ]

    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)


  9. Impact of this study intervention on PBTS: Changes in hippocampal volume [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  10. Impact of this study intervention on PBTS: Changes in neural communication [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  11. Impact of this study intervention on PBTS: Changes in information processing speed [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  12. Impact of this study intervention on PBTS: Changes in controlled attention [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  13. Impact of this study intervention on PBTS: Changes in declarative memory [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  14. Impact of this study intervention on PBTS: Changes in full scale intelligence [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  15. Impact of this study intervention on PBTS: Changes in MEG behavioural measures [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  16. Impact of this study intervention on PBTS: Health and QOL [ Time Frame: Baseline, Week 13, and Week 25 ]

    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.


  17. Impact of this study intervention on PBTS: Changes in cardiovascular fitness (heart rate, and sub-maximal and maximal work rates) [ Time Frame: Baseline, Week 13, and Week 25 ]

    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


  18. Impact of this study intervention on PBTS: Changes in physical functioning (bilateral coordination and balance, and running speed/agility and strength, and ataxia) [ Time Frame: Baseline, Week 13, and Week 25 ]

    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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05367076


Contacts
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Contact: Donald J Mabbott, Ph.D. 416-813-7654 ext 308875 donald.mabbott@sickkids.ca
Contact: Cynthia de Medeiros, M.Sc. 416-813-7396 ext 307396 cynthia.demederios@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Donald J Mabbott, Ph.D.    416-813-7654 ext 308875    donald.mabbot@sickkids.ca   
Contact: Cynthia de Medeiros, M. Sc.    416-813-7396 ext 307396    cynthia.demederios@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Donald J Mabbott The Hospital for Sick Children
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Responsible Party: Donald Mabbott, Senior Scientist and Program Head, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT05367076    
Other Study ID Numbers: 1000073462
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Donald Mabbott, The Hospital for Sick Children:
Exercise
Physical functioning
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases