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Completed

NCT Number: NCT01916486

Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke

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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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise Training

Behavioral

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

Other names: EX Program

Complex mental and social activities

Behavioral

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

Other names: Cog-Plus Program

Control: stretching and relaxation program

Behavioral

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

Other names: CON Program

Primary outcomes

  1. Change from baseline in cognitive function as measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Plus) at 6 months

    Time frame: Baseline and 6 months

    ADAS-Cog 13 + additional measures of executive functions. For ADAS-Cog 13, higher scores indicate greater impairment.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Change from baseline in category fluency.

    Time frame: Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months

  5. 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

  6. Change from baseline in instrumental activities of daily living as measured by the Instrumental Activities of Daily Living Scale.

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Higher scores indicate better performance.

  7. Change from baseline in fatigue as measured by the Fatigue Severity Scale.

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Higher scores indicate greater fatigue.

  8. Change from baseline in physical activity level as measured by the Community Healthy Activities Model Program for Seniors Questionnaire (CHAMPS).

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Acquired on a monthly basis. Higher scores indicate greater activity.

  9. Change from baseline in community mobility as measured by the Life-space Assessment (LSA).

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Higher scores indicate greater community mobility.

  10. Change from baseline in leisure activity as measured by the Shortened Nottingham Leisure Scale.

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Acquired on a monthly basis. Higher scores indicate greater leisure activity.

  11. 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

  12. Change from baseline in functional capacity as measured by the 6 Minute Walk Test.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  13. 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

  14. Change from baseline in quadriceps strength.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  15. Change from baseline in grip strength.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  16. Change from baseline in mood as measured by the Center for Epidemiologic Studies Depression Scale.

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Higher scores indicate greater impairment in mood.

  17. Change from baseline in quality of life as measured by the European Quality of Life-5 Dimensions (EQ-5D).

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Acquired on a monthly basis.

  18. Change from baseline in quality of life as measured by European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS).

    Time frame: Baseline, 3 months, 6 months, and 12 months

    Acquired on a monthly basis.

  19. Change from Baseline in Cognitive Function as Measured by the Alzheimer's Disease Assessment Scale Cognitive Subscale Plus (ADAS-Cog Plus) at 12 months

    Time frame: 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.

  20. Change from Baseline in sleep quality as measured by the Pittsburgh Sleep Index.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  21. Change from Baseline in sleep quality as measured by the Motion Watch 8.

    Time frame: Baseline, 3 months, 6 months, and 12 months

  22. Change from Baseline in lipid profile.

    Time frame: Baseline and 6 months

  23. Change from Baseline in insulin sensitivity.

    Time frame: Baseline and 6 months

  24. Health care resource usage.

    Time frame: Baseline, 3, and 6 months

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial

Acronym: Vitality

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Aug 5, 2013
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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