Vincent Tiffreau1, François Rannou2, François Kopciuch3, Eric Hachulla4, Luc Mouthon5, Philippe Thoumie6, Jean Sibilia7, Elodie Drumez8, André Thevenon9. 1. Rehabilitation Unit, Lille University Hospital, Lille, France; Research Unit 7369, Physical Activity, Muscle Health, University of Lille, Lille, France. Electronic address: vincent.tiffreau@chru-lille.fr. 2. Rehabilitation Unit, Rheumatology Department, Hôpital Cochin, Assistance Publique, Hopitaux de Paris, National Institute for Health and Medical Research UMR-S 1124, Paris, France. 3. Rehabilitation Unit, Lille University Hospital, Lille, France. 4. U995 Lille Inflammation Research International Center, Lille, France; Internal Medicine and Clinical Immunology Department, Systemic Sclerosis and Rare Autoimmune Diseases Reference Center, Lille, France; Immune-Mediated Inflammatory Diseases and Targeted Therapies (IMMINeNT), Lille, France. 5. National Institute for Health and Medical Research, U1016, Institut Cochin, CNRS, UMR8104, University Paris-Descartes, Sorbonne-Paris-Cité, Paris, France. 6. Assistance Publique, Hopitaux de Paris, Neurorehabilitation Centre for Neuromuscular Disorders, Rothschild Hospital, Université Pierre et Marie Curie Paris 6, Paris, France. 7. Faculty of Medicine, National Institute for Health and Medical Research UMR_S1109, LabEx Transplantex, Immunology and Hematology Research Center, University of Strasbourg, Strasbourg, France. 8. Research Unit 2694, Public Health, Epidemiology and Quality of Care, Centre Hospitalier Régional, University of Lille, Lille, France. 9. Rehabilitation Unit, Lille University Hospital, Lille, France; Research Unit 7369, Physical Activity, Muscle Health, University of Lille, Lille, France.
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.
RCT Entities:
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.
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