Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke "Vitality"

Recruiting

Phase N/A Results N/A

Trial Description

The investigators will conduct a proof-of-concept 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 three measurement sessions: baseline, 6 months (end of intervention period); and 12 months.

Conditions

Interventions

  • Exercise training Behavioral
    Other Names: EX Program
    Intervention Desc: The EX Program will provide objective progression in the guided exercises of each participant.
    ARM 1: Kind: Experimental
    Label: Exercise training
    Description: Twice-weekly for the 6-month duration.
  • Complex mental and social activities Behavioral
    Other Names: Cog-Plus Program
    Intervention Desc: The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
    ARM 1: Kind: Experimental
    Label: Complex mental and social activities
    Description: Twice-weekly for the 6-month duration.
  • Control: stretching and relaxation program Behavioral
    Other Names: CON Program
    Intervention Desc: The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.
    ARM 1: Kind: Experimental
    Label: Control: stretching and relaxation program
    Description: Twice-weekly for the 6-month duration.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale at 6 months baseline and 6 months No
Secondary Change from baseline in executive functions as measured by the Stroop Test, the Trail Making Test (Parts A & B), and the verbal digits forward and backward tests at 6 and 12 months baseline, 6 months, and 12 months No
Secondary Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale and the Timed Instrumental Activities of Daily Living at 6 and 12 months baseline, 6 months, and 12 months No
Secondary Change from baseline in physical activity level as measured by the Physical Activity Scale for Individuals with Physical Disabilities at 6 and 12 months baseline, 6 months, and 12 months No
Secondary Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery at 6 and 12 months baseline, 6 months, and 12 months No
Secondary Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale at 6 and 12 months baseline, 6 months, and 12 months No
Secondary Change from baseline in quality of life as measured by the Medical Outcomes Study Short Form-12 at 6 and 12 months baseline, 6 months, and 12 months No
Secondary Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale at 12 months baseline and 12 months No
Primary 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 No
Secondary Change from baseline in executive functions as measured by the Stroop Test, Tower of London Test, the Trail Making Test (Parts A & B), category fluency, and the verbal digits forward and backward tests at 6 and 12 months baseline, 3 months (for subset of outcomes), 6 months, and 12 months No
Secondary Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale at 6 and 12 months baseline, 3 months, 6 months, and 12 months No
Secondary Change from baseline in physical activity level as measured by the Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS) and Shortened Nottingham Leisure Scale at 6 and 12 months baseline, 3 months, 6 months, and 12 months No
Secondary Change from baseline in general balance and mobility as measured by the Short Physical Performance Battery, 6 Minute Walk Test, Timed Up-and-Go Test, and quadriceps and grip strength at 6 and 12 months baseline, 3 months, 6 months, and 12 months No
Secondary Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D) and European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) at 6 and 12 months Baseline, 3 months, 6 months, and 12 months No
Secondary Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus at 12 months baseline and 12 months No

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