Dementia Clinical Trial
— CHIMEOfficial title:
How do we Get People With MCI and Dementia to be Physically Active?
NCT number | NCT02774720 |
Other study ID # | 20687 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | March 2019 |
Verified date | September 2018 |
Source | University of Waterloo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | March 2019 |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Research Institute | Toronto | Ontario |
Canada | University of Waterloo | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Waterloo | Alzheimer's Association |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) | Change in continuous scores | baseline to 3 months | |
Other | Change in cognitive function as characterized by the Stroop task | Change in continuous scores | baseline to 3 months | |
Other | Change in cognitive function as characterized by the Trail making task | Change in continuous scores | baseline to 3 months | |
Other | Change in cognitive function as characterized by the semantic fluency | Change in continuous scores | baseline to 3 months | |
Other | Change in physical function as characterized by the Short Physical Performance Battery (SPPB) scores | Change in continuous scores | baseline to 3 months | |
Other | Change in quality of life as measured with the EuroQol five dimensions questionnaire (EQ-5D) | Change in continuous scores | baseline to 3 months | |
Other | 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 | |
Other | Change in daily function as characterized using the 6-item Disability Assessment for Dementia (DAD-6) | Change in score | baseline to 3 months | |
Other | Change in body mass index (BMI) | Change in score | baseline to 3 months | |
Other | Change in waist circumference | Change in score | baseline to 3 months | |
Other | 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 | |
Primary | 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 | |
Primary | Change in physical activity | Change in physical activity as objectively measured using an activity monitor. | baseline to 3 months | |
Secondary | Cost-effectiveness | Cost of resource utilization per minute change in physical activity. | 3 months |
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