Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

Instituto Politécnico de Setúbal. Escola Superior de Saúde.

Status

Unknown

Conditions

Fibromyalgia

Treatments

Other: Active Comparator: Exercise

Other: Experimental: Exercise and Patient-centred education

Study type

Interventional

Funder types

Other

Identifiers

NCT04220567

IPSetubalESS_SHARE

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.