Behavioral Intervention and Guided Stepping Training Early Post-Stroke

Official title

Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.

Overview

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

• Behavioral Behavior 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 beh
• Behavioral DELAYED 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.

Primary outcome measures

• Physical functioning: Step Counts [Time frame: Difference in changes from baseline to 3 months (post intervention/post waiting)]

Secondary outcome measures (6)

• Sedentary time [Time frame: Change from baseline at 3, 6, 9 and 12 months.]
• Global Disability [Time frame: Change from baseline at 3, 6, 9 and 12 months.]
• Functional mobility [Time frame: Change from baseline at 3, 6, 9 and 12 months.]
• Gait Speed [Time frame: Change from baseline at 3, 6, 9 and 12 months.]
• Walking Endurance [Time frame: Change from baseline at 3, 6, 9 and 12 months.]
• Self efficacy [Time frame: Change from baseline at 3, 6, 9 and 12 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 6 centers

• Carewest Dr Vernon Fanning Centre — Calgary
• Foothills Medical Center — Calgary
• Glenrose Rehabilitation Hospital — Edmonton
• Royal Alexandra Hospital — Edmonton
• University of Alberta Hospital — Edmonton
• Grey Nuns Community Hospital — Edmonton

Identifiers

NCT: NCT07702643 · Pro00140017

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗