Postrehabilitation Functional Improvements in Patients With Inflammatory Myopathies: The Results of a Randomized Controlled Trial

Abstract

Objective: To evaluate the medium-term functional effect and the effect on quality of life of a standardized rehabilitation program in patients with inflammatory myopathies (IMs).

Design: A multicenter, randomized controlled trial.

Setting: Four university hospitals.

Participants: Patients (N=21) with polymyositis.

Interventions: The intervention group participated in a 4-week standardized, hospital-based rehabilitation program followed by a personalized, self-managed, home-based rehabilitation program. The control group received physiotherapy on an outpatient basis. Study participants were evaluated at inclusion, at the end of the rehabilitation program (1mo), and then at 6 and 12 months.

Main outcome measures: The primary efficacy criterion was the Health Assessment Questionnaire Disability Index (HAQ-DI), and the secondary criteria were quality of life (according to the Medical Outcomes Study 36-Item Short-Form Health Survey [SF-36] questionnaire), muscle performance (isokinetic strength, Motor Function Measure, and Kendall Manual Muscle Test), gait, pain, fatigue, and biomarkers of tolerance and disease activity.

Results: At 12 months, the mean ± SD HAQ-DI was significantly lower in the intervention group than in the control group (.64±.53 vs 1.36±1.02; P=.026). The intervention group also had better scores than the control group for some quality-of-life dimensions (SF-36 General Health: 53.44±8.73 vs 36.57±22.10, respectively; P=.038; SF-36 Role Physical: 63.89±43.50 vs 17.86±37.40, respectively; P=.023) and pain levels (5.0±10.61 vs 33.38±35.68, respectively; P=.04) at 12 months. The program was well tolerated by all the participants.

Conclusions: In patients with IMs, the combination of a 4-week standardized rehabilitation program and a personalized, home-based, self-managed rehabilitation program was well tolerated and had a positive medium-term functional effect.

Trial registration: ClinicalTrials.gov NCT01415219.

Keywords: Myositis; Quality of life; Rehabilitation.