Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke

Not Applicable

Completed

• Conditions: Chronic Stroke; Stroke
• Interventions: Behavioral: Exercise training; Behavioral: Complex mental and social activities

• Registration Number: NCT01916486
• Lead Sponsor: University of British Columbia

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

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 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 Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Study Start: 2013-11
• Primary Completion: 2019-08
• Study Completion: 2020-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise training	Exercise training	Twice-weekly for the 6-month duration.
Complex mental and social activities	Complex mental and social activities	Twice-weekly for the 6-month duration.

Primary Outcome Measures

Name	Time	Method
Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months	Baseline and 6 months	ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in category fluency.	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.	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.	Baseline, 3 months, 6 months, and 12 months	Higher scores indicate better performance.
Change from baseline in general balance and mobility as measured the Timed Up-and-Go Test.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in executive functions as measured by the Tower of London Test.	Baseline, 3 months (for subset of cognitive outcomes), 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).	Baseline, 3 months, 6 months, and 12 months	Acquired on a monthly basis. Higher scores indicate greater activity.
Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.	Baseline, 3 months, 6 months, and 12 months	Acquired on a monthly basis. Higher scores indicate greater leisure activity.
Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.	Baseline, 3 months, 6 months, and 12 months	Higher scores indicate greater impairment in mood.
Change from baseline in executive functions as measured by the Stroop Test.	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).	Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months
Change from baseline in community mobility as measured by the Life-space Assessment (LSA).	Baseline, 3 months, 6 months, and 12 months	Higher scores indicate greater community mobility.
Change from baseline in functional capacity as measured by the 6 Minute Walk Test.	Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.	Baseline, 3 months, 6 months, and 12 months
Change from Baseline in sleep quality as measured by the Motion Watch 8.	Baseline, 3 months, 6 months, and 12 months
Change from baseline in grip strength.	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).	Baseline, 3 months, 6 months, and 12 months	Acquired on a monthly basis.
Change from baseline in quality of life as measured by European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS).	Baseline, 3 months, 6 months, and 12 months	Acquired on a monthly basis.
Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Cog Plus) at 12 months	Baseline, 3 months, 6 months, and 12 months	ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog Plus, higher scores indicate greater impairment.
Change from baseline in fatigue as measured by the Fatigue Severity Scale.	Baseline, 3 months, 6 months, and 12 months	Higher scores indicate greater fatigue.
Change from baseline in quadriceps strength.	Baseline, 3 months, 6 months, and 12 months
Change from Baseline in lipid profile.	Baseline and 6 months
Change from Baseline in insulin sensitivity.	Baseline and 6 months
Health care resource usage.	Baseline, 3, and 6 months

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada