None listed
Conditions
Brief summary
The aims of this project are to investigate the applicability, safety, falls incidence, and incremental cost-effectiveness ratio of a prevention of falls program through Tele-SSE in women with fibromyalgia. A randomized controlled trial with experimental (Tele-SSE) and control (usual treatment) groups will be carried out. A focus group will include agents to identify key points to transfer the findings to the public and private sectors in Extremadura. The hypothesis is that this project will improve the efficiency and equity of physical therapy services based on tele-exercise in preventing falls in people with fibromyalgia and will reduce the expenses in the health system by an increase in the cost-effectiveness of the treatment used.
Interventions
Experimental group will receive Tele-Square Step Exercise training (Tele-SSE), three times per week and during 14 weeks. Each training session will have a duration close to 50 minutes. They will be given training guidelines through a booklet designed specifically for this study and the session will be tracked through video-conferencing on a mobile phone. The intervention will be administered by a graduate in Physical Activity and Sports Sciences. Two to six patients will simultaneously perform t
Experimental group will receive Tele-Square Step Exercise training (Tele-SSE), three times per week and during 14 weeks. Each training session will have a duration close to 50 minutes. They will be given training guidelines through a booklet designed specifically for this study and the session will be tracked through video-conferencing on a mobile phone. The intervention will be administered by a graduate in Physical Activity and Sports Sciences. Two to six patients will simultaneously perform the exercise protocol in the same place, which will be normally a room or dependency yielded by each participating association, including Internet connection via WIFI. The SSE intensity will be given by the movement patterns difficulty, distinguishing three different levels: beginner, intermediate and advanced. There will be a progression in the levels in the proposed intervention. People should not step on the dividing lines of squares. The number of steps patterns and difficulty will increase monthly until achieving the maximum level, which will be maintained until the end of the intervention. A checklist will be used by the study personnel in order to control the participants' adherence to the intervention. Once the randomized controlled trial has been carried out, and considering its preliminary results, a focus group will be set up around questions previously drawn up by the research group, in order to determine the acceptability of Tele-SSE in the social-sanitary system agents. Key factors will also be identified for its transfer to the public and private social-sanitary system.
Sponsors
Health, Economy, Motricity and Education (HEME), Faculty of Sport Sciences, University of Extremadura
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
A woman diagnosed with fibromyalgia by a rheumatologist, meet the diagnostic criteria of the American College of Rheumatology, not be physically active as defined by WHO during the previous 3 months, have the ability to walk and communicate on her own, and have access to a telephone in which video-conferencing can be conducted.
Exclusion criteria
Present any pathology that contraindicates the exercise program or requires special attention (coronary pathologies, thrombosis, bone, renal, moderate or severe pulmonary, etc.) or the use of psychotropics or that affects the vestibular system (Parkinson's, etc.).
Outcome results
None listed