Stroke
Conditions
Keywords
stroke, daily steps, sedentary time, self efficacy
Brief summary
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.
Interventions
BEHAVIORALBehavior and guided stepping training intervention (BIG STEPS)
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.
BEHAVIORALDELAYED Behavior and guided stepping training intervention
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.
Sponsors
University of Alberta
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Behavioral: Behavior and guided stepping training
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 50 - or older * Had an ischemic or hemorrhagic stroke within the last 3 months * Have recently returned or are returning home from hospital * Able to walk 5 meters with or without a gait aid
Exclusion criteria
* Previously diagnosed with a mobility limiting musculoskeletal condition * Previously diagnosed with a mobility limiting neurological condition * Have cardiac conditions (e.g. blood pressure ≥180/100 mmHg) * Are without access to an internet-enabled computer or mobile device * Are enrolled in another interventional trial such as exercise or neuroprotection trials * Have aphasia or are unable to provide consent in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical functioning: Step Counts | Difference in changes from baseline to 3 months (post intervention/post waiting) | activPAL derived step counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary time | Change from baseline at 3, 6, 9 and 12 months. | activPAL-derived sedentary time. |
| Global Disability | Change from baseline at 3, 6, 9 and 12 months. | Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome. |
| Functional mobility | Change from baseline at 3, 6, 9 and 12 months. | Timed Up and Go Test (TUG) |
| Gait Speed | Change from baseline at 3, 6, 9 and 12 months. | 10-meter walk test (10MWT) |
| Walking Endurance | Change from baseline at 3, 6, 9 and 12 months. | 6-Minute walk test (6MWT) |
| Self efficacy | Change from baseline at 3, 6, 9 and 12 months. | Stroke Self Efficacy Questionnaire is a 13-item questionnaire. Higher scores in each subscale indicate higher confidence levels and better self-efficacy. |
Countries
Canada
Contacts
CONTACTVictor Ezeugwu, PhD
Outcome results
None listed