Fibromyalgia Musculoskeletal Diseases Fibromyalgia
Conditions
Interventions
Participants are randomly allocated to one of two groups.
Those in the first group are the control group.
Those in the second group perform physical activity within t
Sponsors
University of Extremadura
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women 2. Aged between 30 and 75 years 3. Diagnosed with fibromyalgia by a rheumatologist 4. Able to communicate effectively with the study staff 5. Read and signed the written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Changes in usual care therapies during the 8 weeks of treatment 3. Contraindications for physical exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Health related quality of life is measured using EQ-5D-5L and Whoqol – Brief questionnaires at baseline and 24 weeks 2. Impact of fibromyalgia is measured using Fibromyalgia Impact Questionnaire (FIQ) and its revised version, the FIQ-R at baseline and 24 weeks 3. Cost-effectiveness is measured using EQ-5D-5L and Whoqol – Brief questionnaires at baseline and 24 weeks 4. Activities of daily living and physical fitness (with and without dual-task) are measured at baseline and 24 weeks by: 4.1. Lower limb strength using 30s chair stand test and the 10-step stair climbing test with and without carrying a load 4.2. Hand-grip strength using a grip-strength dynamometer (TKK 5401 Model) 4.3. Aerobic endurance using the Canadian Aerobic Fitness Test and 6 min walking 4.4. Upper body strength using the “Arm Curl Test” 4.5. Balance using Biodex Balance System. This device measures, in degrees, the tilt about each axis during static and dynamic conditions and calculates a mediolateral stability index, an anteroposterior stability index, and an overall stability index 4.6. Chair sit-and-reach and Back scratch to evaluate upper and lower body flexibility 4.7. Cognitive tasks tested using a wireless motion capture device "Functional Assessment of Biomechanics (FAB)" and a wireless electroencephalography (EEG) system (Enobio, Neuroelectrics) in order to assess the motor and brain pattern of the activities of daily living 5. Electrical activity and volumes of important structures of the brain measured at baseline and 24 weeks by: 5.1. Electrical activity at rest using Enobio (Neuroelectrics, Cambridge, MA, USA) 5.2. Volumes of structures such as hippocampus or pineal gland using Magnetic Resonance Imaging (MRI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive impairment is measured using the Mini-Mental State Examination (MMSE) and executive function with the Stroop test at baseline and 24 weeks 2. Psychophysiological response to daily life activities is measured using EEG register while they are watching a video where people are doing different daily activities with and without pain at baseline and 24 weeks 3. Pain-related fear measured using the Tampa Scale for Kinesiophobia (TSK- 11SV) at baseline and 24 weeks 4. Cortisol and melatonin levels are measured using saliva samples at baseline and 24 weeks 5. Pain is measured using the Visual Analog Scale (VAS) and with an algometer on the fibromyalgia-specific tender points at baseline and 24 weeks 6. Depression is assessed using the Geriatric Depression Scale (GDS) at baseline and 24 weeks 7. Body composition is measured using a bioelectrical impedance analysis (Tanita BC-415) and waist to hip ratio at baseline and 24 weeks 8. Perceived effort using a Borg Scale is measured at each session (after finishing each session) 9. Drug treatment is measured using questionnaires at baseline and 24 weeks 10. Cost-effectiveness analysis is measured using the number of visits to the health care system in the last six months at baseline and 24 weeks 11. Self-reported work absence is assessed by a single question asking the number of days that participants had to miss work in the last 6 months at baseline and 24 weeks 12. Fear of falling will be assessed with a VAS from 0 (no fear) to 100 (extreme fear) and using the FES-I questionnaire at baseline and 24 weeks 13. Number of falls are recorded as the self-reported number of falls in the last year and in the last six months at baseline and 24 weeks 14. Volume of physical activity in their free time is measured using th | — |
Countries
Spain
Outcome results
None listed