Centre- Versus Home-based Exercise for MCI and Early Dementia
CHIME
How do we Get People With MCI and Dementia to be Physically Active?
1 other identifier
interventional
44
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2016
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMay 29, 2019
September 1, 2018
2.5 years
April 7, 2016
May 27, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Cost-effectiveness
3 months
Other Outcomes (11)
Change in cognitive function as characterized by Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog)
baseline to 3 months
Change in cognitive function as characterized by the Stroop task
baseline to 3 months
Change in cognitive function as characterized by the Trail making task
baseline to 3 months
- +8 more other outcomes
Study Arms (2)
Centre-based physical activity
EXPERIMENTALPeople 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
EXPERIMENTALPeople with Mild Cognitive Impairment (MCI) and early dementia be prescribed at-home prescribed exercise and will received monthly support phone calls.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of MCI or mild dementia
- Mini-Mental State Examination (MMSE)\>=23 or Montreal Cognitive Assessment (MoCA)\>=18
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Waterloolead
- Alzheimer's Associationcollaborator
Study Sites (2)
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
University of Waterloo
Waterloo, Ontario, N2L3G1, Canada
Related Publications (1)
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.
PMID: 29370756DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2016
First Posted
May 17, 2016
Study Start
September 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
May 29, 2019
Record last verified: 2018-09