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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training | Experimental | Twice-weekly for the 6-month duration. |
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| Complex mental and social activities | Experimental | Twice-weekly for the 6-month duration. |
|
| Control: stretching and relaxation program | Active Comparator | Twice-weekly for the 6-month duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training | Behavioral | The EX Program will provide objective progression in the guided exercises of each participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 executive functions as measured by the Tower of London Test. | Baseline, 3 months (for subset of cognitive outcomes), 6 months, and 12 months |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Vancouver | British Columbia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36227593 | Derived | Liu-Ambrose T, Falck RS, Dao E, Best JR, Davis JC, Bennett K, Hall PA, Hsiung GR, Middleton LE, Goldsmith CH, Graf P, Eng JJ. Effect of Exercise Training or Complex Mental and Social Activities on Cognitive Function in Adults With Chronic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236510. doi: 10.1001/jamanetworkopen.2022.36510. | |
| 30805652 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Complex mental and social activities | Behavioral | The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization. |
|
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| 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. |
|
|
| 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 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. | Higher scores indicate better performance. | Baseline, 3 months, 6 months, and 12 months |
| Change from baseline in fatigue as measured by the Fatigue Severity Scale. | Higher scores indicate greater fatigue. | 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. | 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. | 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. | Baseline, 3 months, 6 months, and 12 months |
| 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 functional capacity as measured by the 6 Minute Walk Test. | Baseline, 3 months, 6 months, and 12 months |
| 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 quadriceps strength. | 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 mood as measured by the Center for Epidemiologic Studies Depression Scale. | Higher scores indicate greater impairment in mood. | 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. | 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. | 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. | 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 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 |
| Falck RS, Best JR, Davis JC, Eng JJ, Middleton LE, Hall PA, Liu-Ambrose T. Sleep and cognitive function in chronic stroke: a comparative cross-sectional study. Sleep. 2019 May 1;42(5):zsz040. doi: 10.1093/sleep/zsz040. |
| 29550783 | Derived | Best JR, Eng JJ, Davis JC, Hsiung R, Hall PA, Middleton LE, Graf P, Goldsmith CH, Liu-Ambrose T. Study protocol for Vitality: a proof-of-concept randomised controlled trial of exercise training or complex mental and social activities to promote cognition in adults with chronic stroke. BMJ Open. 2018 Mar 17;8(3):e021490. doi: 10.1136/bmjopen-2018-021490. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |