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NCT Number: NCT07702643

Behavioral Intervention and Guided Stepping Training Early Post-Stroke

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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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Sedentary Behavior Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carewest Dr Vernon Fanning Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Physical functioning: Step Counts

    Time frame: Difference in changes from baseline to 3 months (post intervention/post waiting)

    activPAL derived step counts

Secondary outcomes

  1. Sedentary time

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    activPAL-derived sedentary time.

  2. Global Disability

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Modified Rankin Scale (mRS) 0-5, higher scores mean worse outcome.

  3. Functional mobility

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Timed Up and Go Test (TUG)

  4. Gait Speed

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    10-meter walk test (10MWT)

  5. Walking Endurance

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    6-Minute walk test (6MWT)

  6. Self efficacy

    Time frame: 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.

Other outcomes

  1. Stanford Gender-Related Variables for Health Research scale

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    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.

  2. Cognition

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    5-minute Montreal Cognitive Assessment (5-min MoCA)

  3. Memory

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Multifactorial Memory Questionnaire 9 (MMQ-9). T scores will be derived. T scores between 40 and 60 are generally interpreted as average.

  4. EuroQol-5 Dimension 5-Level (EQ-5D-5L)

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    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.

  5. Depression

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire where higher scores represent worse outcome.

  6. Fatigue Severity Scale (FSS)

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Fatigue Severity Scale (FSS) is a 9-item questionnaire with higher scores indicating worse outcome

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Pittsburgh Sleep Quality Index (PSQI) scores range from 0 to 21 where higher scores are worse.

  8. Modified Caregiver Stress Index

    Time frame: Change from baseline at 3, 6, 9 and 12 months.

    Modified Caregiver Stress Index is a 13-item questionnaire with higher scores indicating greater caregiver burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Victor Ezeugwu, PhD

CONTACT

[email protected]

780 492 5108

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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.

Acronym: BIG STEPS

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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