Effects of a "test in-train out" walking program versus supervised standard rehabilitation in chronic stroke patients: a feasibility and pilot randomized study

BACKGROUND: The loss of normal ambulatory function after stroke, besides causing disability, leads to progressive deconditioning and exposes patients to increased risk of cardiovascular diseases and recurrent stroke. Conventional rehabilitation is mainly limited to the subacute period after stroke. Effective, safe and sustainable interventions for patients and healthcare system, including the long-term, should be identified. AIM: To verify the feasibility, safety and preliminary efficacy of an original home-based rehabilitation model compared to a standard supervised program in chronic hemiplegic stroke survivors. DESIGN: Pilot, two-arm, parallel group, randomized, controlled clinical trial. SETTING: Community-dwelling poststroke patient/Hospital. POPULATION: Twelve chronic hemiplegic stroke patients (age=66.5 +/- 11.9 years, males, N.=9). METHODS: Participants were randomly assigned for a 10-week period to a structured home-based exercise program (N.=6) and a standard supervised group-setting program (N.=6). The feasibility outcomes included adherence to interventions, retention rate and safety. Satisfaction was also evaluated by the Client Satisfaction Questionnaire. Efficacy was assessed by the 6-minute walk test, Timed Up and Go and Stair Climb tests. The impact on Quality-of-life was estimated using the physical activity domain of the Short Form-36 questionnaire. Operators' time consuming was also calculated. RESULTS: Adherence was 91% in the home-based exercise group and 92% in the standard supervised group. The retention rate was 100%, with no adverse events reported and high satisfaction scores for both interventions. 6-minute walk test and physical activity domain significantly increased in both groups (P=0.03). Timed Up and Go improved in both groups, significantly for the home-based exercise group (P=0.03) while Stair Climb remained stable. Time required to operators to implement the home-based exercise program was 15 hours vs. 30 hours for the standard supervised one. CONCLUSIONS: In a sample of hemiplegic chronic stroke patients, a structured home-based exercise program was feasible, safe and capable of inducing improvements in functional capacity and Quality-of-life comparable to a conventional supervised rehabilitation program A future larger randomized controlled trial will be needed to confirm such results. CLINICAL REHABILITATION IMPACT: With the limitation of a small sample size, the study suggested that a home-based program for chronic stroke might be an effective alternative to traditional supervised programs with the peculiarity of being sustainable for patients and healthcare system.