Safety and Effectiveness of the Walk ‘n Watch Exercise Protocol in Inpatient Stroke Rehabilitation: Insights from a Canadian Phase 3 Stepped-Wedge Trial

Highlights

• The Walk ‘n Watch protocol, a structured, progressive walking exercise program, was implemented across 12 Canadian inpatient stroke rehabilitation units.
• In a pragmatic phase 3 stepped-wedge cluster-randomised trial, Walk ‘n Watch improved 6-minute walk test (6MWT) distance by an average of 43.6 meters over usual care after 4 weeks.
• The intervention was safe, with no serious adverse events occurring during sessions and similar rates of acute care admissions compared to usual care.
• The protocol is feasible to implement with minimal additional resources and demonstrates real-world clinical benefit in subacute stroke rehabilitation.

Clinical Background and Disease Burden

Stroke is a leading cause of long-term disability worldwide, often resulting in impaired walking ability that significantly diminishes patient independence and quality of life. Clinical guidelines advocate for high repetitions of walking practice during inpatient stroke rehabilitation to enhance recovery of walking endurance and function. However, widespread adoption of intensive, progressive walking protocols remains limited in clinical practice, partly due to resource constraints and uncertainty about real-world effectiveness and safety. Improving walking endurance post-stroke is crucial, as it correlates with better community reintegration and reduced caregiver burden. The Walk ‘n Watch protocol was developed to address this gap by providing a structured, progressive exercise approach delivered by frontline physical therapists using objective measures such as heart rate and step count to tailor intensity.

Research Methodology

This study was a pragmatic phase 3, stepped-wedge, cluster-randomised controlled trial conducted across 12 inpatient stroke rehabilitation sites in seven Canadian provinces. Sites were randomly assigned to one of four transition sequences, each including three sites, which switched from usual care to the Walk ‘n Watch protocol at staggered time points. All physical therapists at participating sites received training to deliver the protocol.

The Walk ‘n Watch intervention required patients to complete at least 30 minutes of walking-related activities per therapy session, with progressive increases in intensity guided by heart rate and step counts monitored via wearable devices. A screening 6-minute walk test (6MWT) at baseline informed individualized exercise progression.

The primary endpoint was walking endurance measured by the 6MWT at 4 weeks post-randomization. Evaluations were conducted by assessors blinded to group allocation at baseline and 4-week follow-up. The primary analysis employed a linear mixed-effects model adjusting for unit size, stratum, calendar time, age, sex, and baseline 6MWT.

Key Findings

Between June 2021 and March 2024, 314 participants were enrolled; after exclusions, 306 were analyzed (162 usual care, 144 Walk ‘n Watch). Participants had a mean age of 68 years and were on average 29 days post-stroke at enrollment. Baseline 6MWT distances averaged 152 meters.

At 4 weeks, the Walk ‘n Watch group improved their 6MWT distance from 163.6 m to 297.2 m, whereas the usual care group improved from 137.1 m to 223.6 m. The adjusted between-group difference in 6MWT improvement was 43.6 meters (95% CI 12.7–76.1), favoring Walk ‘n Watch. This magnitude of improvement is clinically meaningful and exceeds commonly accepted minimal clinically important differences for the 6MWT in stroke populations.

Safety outcomes were reassuring: no serious adverse events occurred during Walk ‘n Watch sessions. Nine serious adverse events necessitating acute care admission were reported overall (4 in usual care, 5 in Walk ‘n Watch), suggesting comparable safety profiles.

Interpretation and Clinical Implications

This large, multisite pragmatic trial demonstrates that the Walk ‘n Watch structured, progressive walking protocol implemented by frontline physical therapists significantly enhances walking endurance in subacute stroke patients during inpatient rehabilitation. Importantly, these benefits were achieved without additional serious safety concerns and required minimal additional resources, underscoring the feasibility of integrating this protocol into routine clinical practice.

The use of objective physiological monitoring (heart rate, step count) to tailor exercise intensity represents an advance over traditional subjective approaches, potentially optimizing rehabilitation dosing and outcomes. The stepped-wedge design allowed for real-world implementation and evaluation across diverse clinical settings, enhancing generalizability.

Limitations and Future Directions

Limitations include the relatively short 4-week follow-up period, limiting assessment of long-term functional outcomes and community reintegration. The study did not stratify results by stroke severity or patient characteristics, and further research is needed to identify subgroups most likely to benefit. Additionally, while no increase in serious adverse events was observed, ongoing surveillance is warranted to confirm safety in broader populations.

Future studies could explore integration with other rehabilitation modalities, cost-effectiveness analyses, and patient-reported outcomes to further inform clinical decision-making.

Conclusion

The Walk ‘n Watch structured, progressive exercise protocol is a safe, effective, and feasible intervention to improve walking endurance in patients undergoing inpatient stroke rehabilitation. Its implementation across Canadian stroke units resulted in clinically meaningful gains in mobility, supporting wider adoption. Tailoring exercise intensity using objective monitoring may represent a practical strategy to enhance post-stroke recovery. Further research should focus on identifying patient-specific predictors of response and long-term benefits.

References

Peters S, Hung SH, Bayley MT, Best KL, Connell LA, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Sakakibara BM, Sheehy L, Wong H, Yang Y, Yao J, Eng JJ. Safety and effectiveness of the Walk ‘n Watch structured, progressive exercise protocol delivered by physical therapists for inpatient stroke rehabilitation in Canada: a phase 3, multisite, pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2025 Aug;24(8):643-655. doi: 10.1016/S1474-4422(25)00201-7. PMID: 40683274.