- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774720
Centre- Versus Home-based Exercise for MCI and Early Dementia (CHIME)
How do we Get People With MCI and Dementia to be Physically Active?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this trial is to compare the effectiveness of center-based versus home-based physical activity delivery among people with MCI and early dementia and to understand the influence of person and setting characteristics.
OBJECTIVES:
Primary: To compare the effectiveness of centre-based versus home-based physical activity delivery among people with MCI or early dementia, as measured by percent achievement of physical activity guidelines.
Secondary:
(i) To determine the influence of person- and setting-specific factors. (ii) To estimate the cost-effectiveness of centre-based and home-based physical activity.
Exploratory:
i) To compare the effect of centre- and home-based physical activity on other outcomes.
ii) To explore whether participants consider certain aspects of the program to be important to program effectiveness.
METHODS:
The investigators will conduct a 3-month proof-of-concept, double-blinded randomized, parallel group trial to compare the effectiveness of centre-based and home-based physical activity in helping people with MCI and early dementia meet physical activity recommendations.
Participants will be randomized to one of two physical activity delivery options.The goal of both arms will be to have participants reach physical activity guidelines by the end of the 3-month intervention.
Participants who are randomized to centre-based physical activity will attend physical activity programming at a centre (University of Waterloo or Toronto Rehabilitation Institute) once per week for one hour. Additional physical activity will be prescribed at home.
Participants who are randomized to the home-based physical activity will received a physical activity prescription to be completed at home. They will also receive monthly support calls to assess achievements and barriers and to adjust the prescription.
All assessors will be blinded to group allocation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Research Institute
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Waterloo, Ontario, Canada, N2L3G1
- University of Waterloo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of MCI or mild dementia
- Mini-Mental State Examination (MMSE)>=23 or Montreal Cognitive Assessment (MoCA)>=18
- 50 years or older
- Stable pharmaceutical regimen >=2 months
- Be able to travel to centre
- Have a care partner or significant other to support home-based exercise
- Ability to walk >=2 minutes
- Adequate English to understand exercise training
- Adequate hearing and vision for cognitive tests
- Able to comply with assessment and training schedule
- Be screened safe for exercise by a physician or certified exercise physiologist
Exclusion Criteria:
- Current moderate or high intensity exercise >=3 times per week
- Unstable cardiovascular disease that precludes exercise
- Musculoskeletal impairments that limit ability to walk
- Pain or other co-morbidities that would limit exercise
- Behavioural issues that would limit exercise training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Centre-based physical activity
People with Mild Cognitive Impairment (MCI) and early dementia will receive centre-based physical activity for one hour each week for three months, plus at-home prescribed exercise.
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Participants will come to a centre (University of Waterloo or Toronto Rehabilitation Institute) for a one-hour, small group exercise class each week.
The classes will include progressive aerobic and resistance exercise.
They will be prescribed additional exercise to be performed independently (either at home or in the community).
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Experimental: Home-based exercise
People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls.
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Participants will be prescribed aerobic and resistance exercise to be performed independently (either at home or in the community).
They will receive monthly phone calls to discuss achievements and barriers and to tje adjust exercise prescription.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achievement of Physical Activity
Time Frame: 3 months
|
Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor.
|
3 months
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Change in physical activity
Time Frame: baseline to 3 months
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Change in physical activity as objectively measured using an activity monitor.
|
baseline to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness
Time Frame: 3 months
|
Cost of resource utilization per minute change in physical activity.
|
3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)
Time Frame: baseline to 3 months
|
Change in continuous scores
|
baseline to 3 months
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Change in cognitive function as characterized by the Stroop task
Time Frame: baseline to 3 months
|
Change in continuous scores
|
baseline to 3 months
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Change in cognitive function as characterized by the Trail making task
Time Frame: baseline to 3 months
|
Change in continuous scores
|
baseline to 3 months
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Change in cognitive function as characterized by the semantic fluency
Time Frame: baseline to 3 months
|
Change in continuous scores
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baseline to 3 months
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Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores
Time Frame: baseline to 3 months
|
Change in continuous scores
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baseline to 3 months
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Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D)
Time Frame: baseline to 3 months
|
Change in continuous scores
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baseline to 3 months
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Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales)
Time Frame: baseline to 3 months
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Change in scores, number meeting screening criteria for depression
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baseline to 3 months
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Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6)
Time Frame: baseline to 3 months
|
Change in score
|
baseline to 3 months
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Change in body mass index (BMI)
Time Frame: baseline to 3 months
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Change in score
|
baseline to 3 months
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Change in waist circumference
Time Frame: baseline to 3 months
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Change in score
|
baseline to 3 months
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Change in blood pressure
Time Frame: baseline to 3 months
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Change in number with high blood pressure (>140 systolic blood pressure (SBP), >90 diastolic blood pressure (DBP))
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baseline to 3 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20687
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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