Abstract
BACKGROUND: Women with fibromyalgia (FM) have 2.5 falls per year compared to the 0.5 falls in people without FM. This fact poses a significant health expense. Square Stepping Exercise (SSE) is a balance training system that has been shown to be effective in preventing falls in the elderly. However, there are neither studies in people with FM nor studies that apply SSE through video-conferencing (Tele-SSE). The objectives of this project are 1) to investigate the applicability, safety, decrease in the number of falls, and incremental cost-effectiveness ratio of prevention of falls program through Tele-SSE in women with FM, and 2) to study the transfer of obtained results to the public and private socio-health economy of Extremadura. Methods/Design: A randomized controlled trial with experimental (Tele-SSE) and control (usual treatment) groups will be carried out. The application of Tele-SSE will be performed for 12 months (three times per week) and one additional follow-up month after the intervention. A focus group including agents to identify key points to transfer the findings to the public and private sectors in Extremadura. One-hundred and eighteen women with FM will be recruited and randomly distributed into the two groups: Experimental (Tele-SSE; n = 59) and control group (Usual care; n = 59). Primary outcome measures will be: 1) Applicability; 2) safety; 3) annual number of falls; and 4) incremental cost-effectiveness ratio. Secondary outcomes will be: 1) Balance; 2) fear of falling; 3) socio-demographic and clinical information; 4) body composition; 5) physical fitness; 6) physical activity and sedentary behavior; 7) quality of life-related to health, mental health, and positive health; 8) pain; 9) disability level; 10) cognitive aspects; and 11) depressive symptoms. Regarding the focus group, the acceptability of the Tele-SSE will be evaluated in social-sanitary agents and will include Tele-SSE in their services offer. A statistical analysis will be carried out by treatment intention and protocol. In addition, a cost-effectiveness analysis from the perspective of the health system will be performed. DISCUSSION: This project aims to improve the efficiency and equity of physical therapy services based on tele-exercise in preventing falls in people with FM. Furthermore, orientations will be given in order to transfer the obtained findings into the social-sanitary system and market.