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Home-based telerehabilitation is not inferior to a centre-based program in patients with chronic heart failure: a randomised trial [with consumer summary] |
Hwang R, Bruning J, Morris NR, Mandrusiak A, Russell T |
Journal of Physiotherapy 2017 Apr;63(2):101-107 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
QUESTION: Is a 12-week, home-based telerehabilitation program conducted in small groups non-inferior to a traditional centre-based program in terms of the change in 6-minute walk distance? Is the telerehabilitation program also non-inferior to a centre-based program in terms of functional capacity, muscle strength, quality of life, urinary incontinence, patient satisfaction, attendance rates, and adverse events? DESIGN: Randomised, parallel, non-inferiority trial with concealed allocation, intention-to-treat analysis and assessor blinding. PARTICIPANTS: Patients with stable chronic heart failure (including heart failure with reduced or preserved ejection fraction) were recruited from two tertiary hospitals in Brisbane, Australia. INTERVENTION: The experimental group received a 12-week, real-time exercise and education intervention delivered into the participant's home twice weekly, using online videoconferencing software. The control group received a traditional hospital outpatient-based program of the same duration and frequency. Both groups received similar exercise prescription. OUTCOME MEASURES: Participants were assessed by independent assessors at baseline (week 0), at the end of the intervention (week 12) and at follow-up (week 24). The primary outcome was a between-group comparison of the change in 6-minute walk distance, with a non-inferiority margin of 28m. Secondary outcomes included other functional measures, quality of life, patient satisfaction, program attendance rates and adverse events. RESULTS: In 53 participants (mean age 67 years, 75% males), there were no significant between-group differences on 6-minute walk distance gains, with a mean difference of 15 m (95% CI -28 to 59) at week 12. The confidence intervals were within the predetermined non-inferiority range. The secondary outcomes indicated that the experimental intervention was at least as effective as traditional rehabilitation. Significantly higher attendance rates were observed in the telerehabilitation group. CONCLUSION: Telerehabilitation was not inferior to a hospital outpatient-based rehabilitation program in patients with chronic heart failure. Telerehabilitation appears to be an appropriate alternative because it promotes greater attendance at the rehabilitation sessions. TRIAL REGISTRATION: ACTRN12613000390785.
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