Behavioral Intervention and Guided Stepping Training Early Post-Stroke

NCT07702643 | Not Yet Recruiting DMC

• 1 other identifier: Pro00140017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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.

Conditions

Stroke

Keywords

stroke; daily steps; sedentary time; self efficacy

Outcome Measures

Primary Outcomes (1)

• Physical functioning: Step Counts

  activPAL derived step counts

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

Secondary Outcomes (6)

• Sedentary time

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

• Global Disability

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

• Functional mobility

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

• Gait Speed

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

• Walking Endurance

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

Other Outcomes (8)

• Stanford Gender-Related Variables for Health Research scale

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

• Cognition

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

• Memory

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

Study Arms (2)

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.

Behavioral: Behavior and guided stepping training intervention (BIG STEPS)

Delayed BIG STEPS

OTHER

The waitlist control group will complete the BIG STEPS intervention after 6 months.

Behavioral: DELAYED Behavior and guided stepping training intervention

Interventions

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.

Early BIG STEPS

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.

Delayed BIG STEPS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (6)

Carewest Dr Vernon Fanning Centre

Calgary, Alberta, T2E 6V7, Canada

Location

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

MeSH Terms

Conditions

Stroke; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Victor Ezeugwu, PhD

CONTACT

780 492 5108; ezeugwu@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Behavioral: Behavior and guided stepping training

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)