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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
The EX Program will provide objective progression in the guided exercises of each participant.
The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.
University of British Columbia
Vancouver, British Columbia, Canada
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.
Time frame: Baseline and 6 months
Change from baseline in executive functions as measured by the Stroop Test.
Time frame: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in executive functions as measured by the Tower of London Test.
Time frame: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in processing speed and executive functions as measured by the Trail Making Tests (Parts A & B).
Time frame: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in category fluency.
Time frame: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in memory and executive functions as measured by the verbal digits forward and backward tests.
Time frame: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale.
Higher scores indicate better performance.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in fatigue as measured by the Fatigue Severity Scale.
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Higher scores indicate greater fatigue.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in physical activity level as measured by the Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS).
Acquired on a monthly basis. Higher scores indicate greater activity.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in community mobility as measured by the Life-space Assessment (LSA).
Higher scores indicate greater community mobility.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.
Acquired on a monthly basis. Higher scores indicate greater leisure activity.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in quadriceps strength.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in grip strength.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.
Higher scores indicate greater impairment in mood.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D).
Acquired on a monthly basis.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from baseline in quality of life as measured by European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS).
Acquired on a monthly basis.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Cog Plus) at 12 months
ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog Plus, higher scores indicate greater impairment.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Motion Watch 8.
Time frame: Baseline, 3 months, 6 months, and 12 months
Change from Baseline in lipid profile.
Time frame: Baseline and 6 months
Change from Baseline in insulin sensitivity.
Time frame: Baseline and 6 months
Health care resource usage.
Time frame: Baseline, 3, and 6 months