An interventional study of Behavior and guided stepping training intervention (BIG STEPS) and DELAYED Behavior and guided stepping training intervention in Stroke, sponsored by University of Alberta. Recruiting at 6 sites in Canada. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 150 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Behavior and guided stepping training intervention (BIG STEPS)
The waitlist control group will complete the BIG STEPS intervention after 6 months.
Behavioral: DELAYED Behavior and guided stepping training intervention
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.
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.
Physical functioning: Step Counts
activPAL derived step counts
Time frame: Difference in changes from baseline to 3 months (post intervention/post waiting)
Sedentary time
activPAL-derived sedentary time.
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Global Disability
Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome.
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Functional mobility
Timed Up and Go Test (TUG)
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Gait Speed
10-meter walk test (10MWT)
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Walking Endurance
6-Minute walk test (6MWT)
Time frame: 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.
Time frame: Change from baseline at 3, 6, 9 and 12 months.
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.
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Cognition
5-minute Montreal Cognitive Assessment (5-min MoCA)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline at 3, 6, 9 and 12 months.
Plan to share: No — The datasets that will be generated and/or analysed during the current study will not be publicly available due to the sensitivity of personal health information and privacy requirements. After publication of the primary study results, de-identified data sets may be made available on reasonable request to the corresponding author, subject to approval by regulatory authorities
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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