Fibromyalgia
Conditions
Keywords
Fibromyalgia, Exercise, Patient-centred Education, Randomised Controlled Trial
Brief summary
This study aims to compare the effects of an eight-week exercise and patient-centred education programme with eight-week exercise alone programme on disability, pain intensity, health-related quality of life and patient global impression of change. A prospective, parallel, double-blinded and multi-centre randomised controlled trial will be carried out.
Interventions
OTHERExperimental: Exercise and Patient-centred education
An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations). Patient-centred Education will follow the principles of transformative learning & incorporate patients' narratives. It will precede 9 of the 24 exercise sessions and be delivered by the same physiotherapist
OTHERActive Comparator: Exercise
An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations).
Sponsors
Universidade de Lisboa - Faculdade Letras
Centro Hospitalar de Setúbal E.P.E.
Centro Hospitalar Lisboa Ocidental
Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica
Instituto Politécnico de Setúbal. Escola Superior de Saúde.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)
Exclusion criteria
* Presence of uncontrolled medical disorders (cardiovascular/ metabolic/ neurological/ renal) * Presence of active oncological disease (or until 5 years and undergoing treatment) * Presence of inflammatory rheumatic diseases other than fibromyalgia * Presence of inflammatory osteoarticular disease or severe osteoarthritis (grade IV de Kellgren - Lawrence Classification of Osteoarthritis) * Previous orthopaedic (column or lower limb) or cardiothoracic surgery in the year before; * Disability not compatible with the exercise practice required * Pregnancy * Attendance to a physiotherapy programme including exercise in the previous three months * Difficulty in written communication that prevent the fulfilment of self-reported questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Baseline | Measured using the Numeric Pain Rating Scale, NPS, 0-10 |
| Disability and Impact of Fibromyalgia | Baseline | Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic components in pain | Baseline | Measured using the painDETECT Questionnaire |
| Health-related Quality of Life | Baseline | Measured using the EuroQol 5D 3L, EQ 5D-3L |
| Patients' perception of improvement or decline in clinical status | 4 weeks | Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7 |
Countries
Portugal
Outcome results
None listed