Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2020-02-29

Brief Summary

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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 cognitive function in older adults with chronic stroke, compared with a stretch and relaxation program.

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Detailed Description

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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 program. After 6 months of intervention, they will be followed for an additional 6 months. There will be four measurement sessions: baseline, 3 months, 6 months (end of intervention period); and 12 months.

Conditions

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Stroke Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise training

Twice-weekly for the 6-month duration.

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

The EX Program will provide objective progression in the guided exercises of each participant.

Complex mental and social activities

Twice-weekly for the 6-month duration.

Group Type EXPERIMENTAL

Complex mental and social activities

Intervention Type BEHAVIORAL

The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.

Control: stretching and relaxation program

Twice-weekly for the 6-month duration.

Group Type ACTIVE_COMPARATOR

Control: stretching and relaxation program

Intervention Type BEHAVIORAL

The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.

Interventions

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Exercise training

The EX Program will provide objective progression in the guided exercises of each participant.

Intervention Type BEHAVIORAL

Complex mental and social activities

The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.

Intervention Type BEHAVIORAL

Control: stretching and relaxation program

The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.

Intervention Type BEHAVIORAL

Other Intervention Names

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EX Program Cog-Plus Program CON Program

Eligibility Criteria

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Inclusion Criteria

1. Aged 55 years or over;
2. Have a history of a single stroke of at least one year prior to study enrolment;
3. 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;
4. Have subjective cognitive complaints;
5. Community-dwelling;
6. Lives in Metro Vancouver;
7. Able to comply with scheduled visits, treatment plan, and other trial procedures;
8. Must be able to read, write, and speak English in which psychometric tests are provided with acceptable visual and auditory acuity;
9. 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;
10. Able to walk for a minimum of six metres with rest intervals with or without assistive devices;
11. Have an activity tolerance of 60 minutes with rest intervals;
12. Not currently participating in any regular therapy or progressive exercise; and
13. 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

1. Diagnosed with dementia of any type;
2. Diagnosed with another type of neurodegenerative or neurological condition (ie. Parkinson's disease) that affects cognitive function and mobility;
3. 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);
4. Have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her family physician;
5. 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
6. Have aphasia as judged by an inability to communicate by phone.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No