Dementia, Mild Cognitive Impairment
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALCentre-based exercise
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).
BEHAVIORALHome-based exercise
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.
Sponsors
Alzheimer's Association
University of Waterloo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of Physical Activity | 3 months | Percent achievement of physical activity recommendations (150min/wk of moderate or high intensity physical activity) as objectively measured using an activity monitor. |
| Change in physical activity | baseline to 3 months | Change in physical activity as objectively measured using an activity monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 3 months | Cost of resource utilization per minute change in physical activity. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | baseline to 3 months | Change in number with high blood pressure (\>140 systolic blood pressure (SBP), \>90 diastolic blood pressure (DBP)) |
| Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) | baseline to 3 months | Change in continuous scores |
| Change in cognitive function as characterized by the Stroop task | baseline to 3 months | Change in continuous scores |
| Change in cognitive function as characterized by the Trail making task | baseline to 3 months | Change in continuous scores |
| Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6) | baseline to 3 months | Change in score |
| Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores | baseline to 3 months | Change in continuous scores |
| Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D) | baseline to 3 months | Change in continuous scores |
| Change in mood as measured with the Neuropsychiatric Inventory Questionnaire (NPI-Q) (depression/dysphoria, anxiety, apathy/indifference scales) | baseline to 3 months | Change in scores, number meeting screening criteria for depression |
| Change in cognitive function as characterized by the semantic fluency | baseline to 3 months | Change in continuous scores |
| Change in body mass index (BMI) | baseline to 3 months | Change in score |
| Change in waist circumference | baseline to 3 months | Change in score |
Countries
Canada
Outcome results
None listed