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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Centre-based physical activity | Experimental | 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. |
|
| Home-based exercise | Experimental | People with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centre-based exercise | Behavioral | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Cost of resource utilization per minute change in physical activity. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) | Change in continuous scores | baseline to 3 months |
| Change in cognitive function as characterized by the Stroop task |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada | ||
| University of Waterloo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29370756 | Derived | Middleton LE, Black SE, Herrmann N, Oh PI, Regan K, Lanctot KL. Centre- versus home-based exercise among people with mci and mild dementia: study protocol for a randomized parallel-group trial. BMC Geriatr. 2018 Jan 25;18(1):27. doi: 10.1186/s12877-017-0684-0. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| Home-based exercise | Behavioral | 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. |
|
Change in continuous scores
| baseline to 3 months |
| Change in cognitive function as characterized by the Trail making task | Change in continuous scores | baseline to 3 months |
| Change in cognitive function as characterized by the semantic fluency | Change in continuous scores | baseline to 3 months |
| Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores | Change in continuous scores | baseline to 3 months |
| Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D) | Change in continuous scores | baseline to 3 months |
| Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales) | Change in scores, number meeting screening criteria for depression | baseline to 3 months |
| Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6) | Change in score | baseline to 3 months |
| Change in body mass index (BMI) | Change in score | baseline to 3 months |
| Change in waist circumference | Change in score | baseline to 3 months |
| Change in blood pressure | Change in number with high blood pressure (>140 systolic blood pressure (SBP), >90 diastolic blood pressure (DBP)) | baseline to 3 months |
| Waterloo |
| Ontario |
| N2L3G1 |
| Canada |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |