Status:
COMPLETED
Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Stroke
Chronic Stroke
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
The investigators will conduct a randomized controlled trial study to provide preliminary evidence of efficacy of exercise training or a complex mental and social activities program for improving cogn...
Detailed Description
A total of 119 adults diagnosed with chronic stroke will be randomized to either a 6-month twice-weekly exercise program, complex mental and social activities program, or stretch and relaxation progra...
Eligibility Criteria
Inclusion
- The study will specifically recruit individuals who had an ischemic or hemorrhagic stroke and have probable mild cognitive impairment.
- In addition, individuals must meet the following inclusion criteria:
- Aged 55 years or over;
- Have a history of a single stroke of at least one year prior to study enrolment;
- Mini-Mental State Examination (MMSE) (5) score of ≥ 20 at screening, including a perfect score on the 3-step command to ensure intact comprehension and ability to follow instructions;
- Have subjective cognitive complaints;
- Community-dwelling;
- Lives in Metro Vancouver;
- Able to comply with scheduled visits, treatment plan, and other trial procedures;
- Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
- Stable on a fixed dose of cognitive medications (e.g., donepezil, galantamine, rivastigmine, memantine, etc.) that is not expected to change during the 12-month study period, or, if they are not on any of these medications, they are not expected to start them during the 12-month study period;
- Able to walk for a minimum of six metres with rest intervals with or without assistive devices;
- Have an activity tolerance of 60 minutes with rest intervals;
- Not currently participating in any regular therapy or progressive exercise; and
- Provide a personally signed and dated informed consent document indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. In addition, an assent form will be provided at baseline and again at regular intervals.
- Exclusion Criteria:
- Diagnosed with dementia of any type;
- Diagnosed with another type of neurodegenerative or neurological condition (ie. Parkinson's disease) that affects cognitive function and mobility;
- At high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level (i.e., Class C of the American Heart Risk Stratification Criteria);
- Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician;
- Taking medications that may negatively affect cognitive function, such as anticholinergics, including agents with pronounced anticholinergic properties (e.g., amitriptyline), major tranquilizers (typical and atypical antipsychotics), and anticonvulsants (e.g., gabapentin, valproic acid, etc.); or
- Have aphasia as judged by an inability to communicate by phone.
Exclusion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01916486
Start Date
November 1 2013
End Date
February 1 2020
Last Update
August 28 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of British Columbia
Vancouver, British Columbia, Canada