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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.
The investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.
Following randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.
The primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.
The BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early BIG STEPS | Experimental | Using baseline accelerometry data, personalized goals of replacing sedentary time with stepping time will be developed. Participants will start the BIG STEP intervention within 3 months of stroke onset. |
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| Delayed BIG STEPS | Other | The waitlist control group will complete the BIG STEPS intervention after 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavior and guided stepping training intervention (BIG STEPS) | Behavioral | The BIG STEPS intervention comprises a home-based behavioral intervention aimed at reducing and frequently interrupting prolonged sedentary periods, along with guided stepping training to gradually increase daily steps. Participants will wear an accelerometer throughout the whole day for four consecutive days during each assessment. Using baseline accelerometer data, prolonged periods of sedentary time or minimal activity levels will be identified and used to inform personalized activity and behavior-change recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functioning: Step Counts | activPAL derived step counts | Difference in changes from baseline to 3 months (post intervention/post waiting) |
| Measure | Description | Time Frame |
|---|---|---|
| Sedentary time | activPAL-derived sedentary time. | Change from baseline at 3, 6, 9 and 12 months. |
| Global Disability | Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Stanford Gender-Related Variables for Health Research scale | The Stanford Gender-Related Variables for Health Research scale is a 25-item self-report survey that measures how specific gender-related behaviors and roles impact physical and mental well-being. | Change from baseline at 3, 6, 9 and 12 months. |
| Cognition |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor Ezeugwu, PhD | Contact | 780 492 5108 | ezeugwu@ualberta.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carewest Dr Vernon Fanning Centre | Calgary | Alberta | T2E 6V7 | Canada |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Behavioral: Behavior and guided stepping training
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| DELAYED Behavior and guided stepping training intervention | Behavioral | The waitlist control group will complete the BIG STEPS intervention after 6 months. During the waiting period they will receive usual care and educational materials. |
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| Change from baseline at 3, 6, 9 and 12 months. |
| Functional mobility | Timed Up and Go Test (TUG) | Change from baseline at 3, 6, 9 and 12 months. |
| Gait Speed | 10-meter walk test (10MWT) | Change from baseline at 3, 6, 9 and 12 months. |
| Walking Endurance | 6-Minute walk test (6MWT) | Change from baseline at 3, 6, 9 and 12 months. |
| Self efficacy | Stroke Self Efficacy Questionnaire is a 13-item questionnaire. Higher scores in each subscale indicate higher confidence levels and better self-efficacy. | Change from baseline at 3, 6, 9 and 12 months. |
5-minute Montreal Cognitive Assessment (5-min MoCA) |
| Change from baseline at 3, 6, 9 and 12 months. |
| Memory | Multifactorial Memory Questionnaire 9 (MMQ-9). T scores will be derived. T scores between 40 and 60 are generally interpreted as average. | Change from baseline at 3, 6, 9 and 12 months. |
| EuroQol-5 Dimension 5-Level (EQ-5D-5L) | The 5-level EQ-5D version (EQ-5D-5L) is a patient-reported quality of life measure. Country-specific valuation set will be used. The EQ-5D VAS score rates perceived health on a scale of 0-100, where higher scores are better. | Change from baseline at 3, 6, 9 and 12 months. |
| Depression | Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire where higher scores represent worse outcome. | Change from baseline at 3, 6, 9 and 12 months. |
| Fatigue Severity Scale (FSS) | Fatigue Severity Scale (FSS) is a 9-item questionnaire with higher scores indicating worse outcome | Change from baseline at 3, 6, 9 and 12 months. |
| Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index (PSQI) scores range from 0 to 21 where higher scores are worse. | Change from baseline at 3, 6, 9 and 12 months. |
| Modified Caregiver Stress Index | Modified Caregiver Stress Index is a 13-item questionnaire with higher scores indicating greater caregiver burden. | Change from baseline at 3, 6, 9 and 12 months. |
| Foothills Medical Center | Calgary | Alberta | T2N 2T9 | Canada |
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| Glenrose Rehabilitation Hospital | Edmonton | Alberta | T5G 0B7 | Canada |
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| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
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| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
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| Grey Nuns Community Hospital | Edmonton | Alberta | T6L 5X8 | Canada |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |