The Efficacy of a Home-Based, Self-Administered Hand Exercise Program for Patients With Systemic Sclerosis: A Randomized Controlled, Evaluator-Blind, Clinical Trial.

BACKGROUND: For patients with systemic sclerosis (SSc), hand involvement is an underrated clinical manifestation. Therefore, the aim of this study was to investigate the efficacy of a hand exercise program and to demonstrate its effect on hand function, quality of life, anxiety, and depression in patients with SSc. METHODS: This study was designed as a single blind, randomized controlled comparative study. Sixty-two female patients with SSc were randomized into an exercise group (n = 32) or a control group (n = 30). After some were lost to follow-up, 25 patients were analyzed in each group. In the exercise group, the 8-week intervention consisted of isometric hand exercises and self-administered stretching repeated 10 times/2 sets per day. All patients were assessed using the Hand Mobility in Scleroderma (HAMIS) test, the Duruoz Hand Index (DHI), grip strength, the 36-item short form, Health Assessment Questionnaire-Disability Index (HAQ-DI), Beck Anxiety Inventory (BAI), and the Beck Depression Inventory (BDI) at baseline and then again 4 and 8 weeks later. Within-group comparisons over time were analyzed using the Friedman test. Post hoc analysis was performed using the Wilcoxon signed rank test. A multiple linear regression analysis was used to define the impact of exercise on clinical status. RESULTS: Of the 50 total patients, the median age and the median body mass index were 55.5 years and 25.9 kg/m2. The median disease duration was 10.0 years. Thirty-four patients (68.0%) were diffuse cutaneous systemic sclerosis (dcSSC), whereas 16 (32.0%) were limited cutaneous systemic sclerosis (lcSSc). The primary outcome of handgrip strength, as well as the HAMIS, DHI, HAQ-DI, and BDI, significantly improved over time (p < 0.001, p < 0.001, p < 0.001, p < 0.001, and p = 0.005, respectively). The between-group comparison indicated significant improvement in DHI, handgrip strength, HAQ-DI, BAI, and BDI in the exercise group (p = 0.02, p = 0.013, p < 0.001, p = 0.015, and p = 0.036, respectively). In the multiple linear regression analysis, exercise was found to be the most efficient factor affecting the improvement in HAMIS, DHI, HAQ-DI, and grip strength. CONCLUSIONS: The 8-week intervention composed of isometric hand exercises and self-administered stretching provided a significant improvement in handgrip strength, general health, quality of life, and psychological status for patients with SSc.