Centre- Versus Home-based Exercise for MCI and Early Dementia

Study Overview
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Brief Summary
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The study is a 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. The primary outcome is achievement of physical activity recommendations. Secondary outcomes include cost-effectiveness and improvements in health and function.

Detailed Description
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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.

Official Title
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How do we Get People With MCI and Dementia to be Physically Active?

Conditions
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Mild Cognitive Impairment, Dementia

Intervention / Treatment
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* Behavioral: Centre-based exercise
* Behavioral: Home-based exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Centre-based physical activity<br>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. | Behavioral: Centre-based exercise<br>* 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).<br>|
| Experimental: Home-based exercise<br>People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls. | Behavioral: Home-based exercise<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of Physical Activity | Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor. | 3 months | 
| Change in physical activity | Change in physical activity as objectively measured using an activity monitor. | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | Cost of resource utilization per minute change in physical activity. | 3 months |