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Vitality: Promoting Cognitive Function in Older Adults With Chronic Stroke (Vitality)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01916486
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : August 28, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Teresa Liu-Ambrose, 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.

Condition or disease Intervention/treatment Phase
Stroke Chronic Stroke Behavioral: Exercise training Behavioral: Complex mental and social activities Behavioral: Control: stretching and relaxation program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Complex Mental and Social Activities to Promote Cognitive Function in Older Adults With Chronic Stroke: A Randomized Controlled Trial
Study Start Date : November 2013
Actual Primary Completion Date : August 2019
Actual Study Completion Date : February 2020

Arm Intervention/treatment
Experimental: Exercise training
Twice-weekly for the 6-month duration.
Behavioral: Exercise training
The EX Program will provide objective progression in the guided exercises of each participant.
Other Name: EX Program

Experimental: Complex mental and social activities
Twice-weekly for the 6-month duration.
Behavioral: Complex mental and social activities
The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
Other Name: Cog-Plus Program

Active Comparator: Control: stretching and relaxation program
Twice-weekly for the 6-month duration.
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.
Other Name: CON Program




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916486


Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Janice J Eng, PhD, PT University of British Columbia
Principal Investigator: Teresa Liu-Ambrose, PhD, PT University of British Columbia
Principal Investigator: Peter Hall, PhD University of Waterloo
Principal Investigator: Charlie Goldsmith, PhD Simon Fraser University
Principal Investigator: Jennifer Davis, PhD University of British Columbia
Principal Investigator: Laura Middleton, PhD University of Waterloo
Principal Investigator: Ging-Yuek Robin Hsiung, MD University of British Columbia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Teresa Liu-Ambrose, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01916486    
Other Study ID Numbers: H13-00715
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases