Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

NCT ID: NCT04220567

Last Updated: 2020-03-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double blind

Study Groups

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Exercise and Patient-centred education

Group Type EXPERIMENTAL

Experimental: Exercise and Patient-centred education

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Active Comparator: Exercise

Intervention Type OTHER

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

Intervention Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade de Lisboa - Faculdade Letras

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar de Setúbal E.P.E.

UNKNOWN

Sponsor Role collaborator

Centro Hospitalar Lisboa Ocidental

OTHER_GOV

Sponsor Role collaborator

Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica

UNKNOWN

Sponsor Role collaborator

Instituto Politécnico de Setúbal. Escola Superior de Saúde.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Carmen Caeiro

Setúbal, , Portugal

Site Status RECRUITING

Countries

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Portugal

Facility Contacts

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Carmen Caeiro, PhD

Role: primary

00351 265 709 382 ext. 5382

Patrícia Falcão, BSc Hons

Role: backup

00351 265 709 382 ext. 5382

Other Identifiers

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IPSetubalESS_SHARE

Identifier Type: -

Identifier Source: org_study_id

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