Effectiveness of Exercise and Patient-centred Education on Fibromyalgia
NCT ID: NCT04220567
Last Updated: 2020-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-01-07
2020-10-31
Brief Summary
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A prospective, parallel, double-blinded and multi-centre randomised controlled trial will be carried out.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Exercise and Patient-centred education
Experimental: 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
Exercise
Active 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).
Interventions
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Experimental: 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
Active 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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Universidade de Lisboa - Faculdade Letras
UNKNOWN
Centro Hospitalar de Setúbal E.P.E.
UNKNOWN
Centro Hospitalar Lisboa Ocidental
OTHER_GOV
Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica
UNKNOWN
Instituto Politécnico de Setúbal. Escola Superior de Saúde.
OTHER
Responsible Party
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Locations
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Carmen Caeiro
Setúbal, , Portugal
Countries
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Facility Contacts
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Other Identifiers
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IPSetubalESS_SHARE
Identifier Type: -
Identifier Source: org_study_id
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