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| Post-rehabilitation functional improvements in patients with inflammatory myopathies: the results of a randomized, controlled trial |
| Tiffreau V, Rannou F, Kopciuch F, Hachulla E, Mouthon L, Herson S, Thoumie P, Sibilia J, Drumez E, Thevenon A |
| Archives of Physical Medicine and Rehabilitation 2017 Feb;98(2):227-234 |
| clinical trial |
| 5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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OBJECTIVE: To evaluate the medium-term functional impact and effect on quality of life of a standardized rehabilitation programme in patients with inflammatory myopathies (IM). DESIGN: A multicentre, randomized, controlled trial. SETTING: Four university hospitals in France. PARTICIPANTS: 20 patients suffering from polymyositis. INTERVENTIONS: The intervention group participated in a four-week standardized, hospital-based rehabilitation programme and then a personalized, self-managed, home-based rehabilitation programme. The control group received physiotherapy on an outpatient basis. The study participants were evaluated at inclusion, at the end of the rehabilitation programme (1 month) and then at 6 and 12 months. MAIN OUTCOME MEASURE(S): The primary efficacy criterion was the Health Assessment Questionnaire Disability Index (HAQ-DI), and the secondary criteria were quality of life (according to the SF36 questionnaire), muscle performance (isokinetic strength, the Motor Function Measure, and the Kendall Manual Muscle Test (MMT)), gait, pain, fatigue and biomarkers of tolerance and disease activity. RESULTS: At 12 months, the mean +/- standard deviation HAQ-DI was significantly lower in the intervention group than in the control group (0.64 +/- 0.53 versus 1.36 +/- 1.02, respectively; p = 0.026). The intervention group also had better scores than the control group for some quality of life dimensions (SF36 General Health 53.44 +/- 8.73 versus 36.57 +/- 22.10, respectively; p = 0.038; SF36 Role Physical 63.89 +/- 43.50 versus 17.86 +/- 37.40, respectively; p = 0.023) and pain levels (5.0 +/- 10.61 versus 33.38 +/- 35.68, respectively; p = 0.04) at 12 months. Lastly, the programme was well tolerated by all the participants. CONCLUSION(S): In patients suffering from (IM), the combination of a four-week standardized rehabilitation programme and a personalized, home-based, self-managed rehabilitation programme was well tolerated and had a positive medium-term functional impact.
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