Clinical trial NCT04220567: Effectiveness of Exercise and Patient-centred Education on Fibromyalgia
Official title: Is a Combined Programme of Exercise and Patient-centred Education More Effective Than Exercise Alone in Individuals With Fibromyalgia? A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Exercise
Patient-centred Education
Randomised Controlled Trial
Lead sponsor: Instituto Politécnico de Setúbal. Escola Superior de Saúde.
Sponsor class: OTHER
Collaborators: name: Universidade de Lisboa - Faculdade Letras
name: Centro Hospitalar de Setúbal E.P.E.
name: Centro Hospitalar Lisboa Ocidental
name: Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica
First posted: 2020-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity
timeFrame: Baseline
measure: Pain intensity
timeFrame: 4 weeks
measure: Pain intensity
timeFrame: 8 weeks
measure: Pain intensity
timeFrame: Follow-up 3 months
measure: Disability and Impact of Fibromyalgia
timeFrame: Baseline
measure: Disability and Impact of Fibromyalgia
timeFrame: 4 weeks
measure: Disability and Impact of Fibromyalgia
timeFrame: 8 weeks
measure: Disability and Impact of Fibromyalgia
timeFrame: Follow-up 3 months
Secondary outcomes:
measure: Neuropathic components in pain
timeFrame: Baseline
measure: Health-related Quality of Life
timeFrame: Baseline
measure: Health-related Quality of Life
timeFrame: 4 weeks
measure: Health-related Quality of Life
timeFrame: 8 weeks
measure: Health-related Quality of Life
timeFrame: Follow-up 3 months
measure: Patients' perception of improvement or decline in clinical status
timeFrame: 4 weeks
measure: Patients' perception of improvement or decline in clinical status
timeFrame: 8 weeks
measure: Patients' perception of improvement or decline in clinical status
timeFrame: Follow-up 3 months
Other outcomes:
Locations:
city: Setúbal
country: Portugal
facility: Carmen Caeiro
Study officials:
References: