Physical therapy could be of interest to reduce disability of systemic sclerosis (SSc) patients.

To develop a physical therapy program for SSc and compare its efficacy with that of usual care.

12-month, parallel-group randomized controlled trial involving a modified Zelen design conducted between September 2005 and October 2011. Randomization was computer-generated with allocation concealment by fax to a central coordinating office. Investigators were not blinded, but participants in the control group were blinded to study hypothesis.

Four tertiary-care hospitals.

Patients were enrolled if they had a SSc diagnosis, a disability rating ≥ 0.5 on the Health Assessment Questionnaire Disability Index (HAQ-DI) or complaints of decreased mouth opening or limited range of motion of at least one joint.

The experimental intervention was a 1-month personalized supervised physical therapy program provided by specifically trained care providers followed by home sessions. The comparator was usual care.

The primary outcome was the HAQ-DI score at 12 months.

In the intention-to-treat analysis, as compared with the usual care group (n=108), patients in the physical therapy group (n=110) showed reduced disability at 1 month (HAQ-DI between-group difference (0.14; 95% confidence interval [CI] –0.24 to –0.03; P=0.01), at 6 months the HAQDI scores between-group difference was –0.12; 95% CI, –0.23 to 0.01; P=0.054. There was no statistically significant difference at 12 months (between-group difference at 12 months, –0.01; 95% CI –0.15 to 0.13; P=0.86). There was a statistically significant difference for hand mobility and function, and pain, at 1 month but no difference at 12 months. Microstomia was lower in the physical therapy group at 1, 6 and 12 months (between-group difference at 12 months, 1.62; 95% CI 0.32 to 2.93; P=0.01). No differences in adverse effects were observed between the two treatment groups.

A 1-month personalized supervised physical therapy program followed by home exercise sessions had short-term benefits for patients with SSc but did not reduce disability at 12 months. The program had long-term benefits for microstomia.

NCT00318188.