Centre- Versus Home-based Exercise for MCI and Early Dementia
- Conditions
- Mild Cognitive ImpairmentDementia
- Interventions
- Behavioral: Home-based exerciseBehavioral: Centre-based exercise
- Registration Number
- NCT02774720
- Lead Sponsor
- University of Waterloo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home-based exercise 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. Centre-based physical activity Centre-based exercise 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cost-effectiveness 3 months Cost of resource utilization per minute change in physical activity.
Trial Locations
- Locations (2)
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada
University of Waterloo
🇨🇦Waterloo, Ontario, Canada