NCT04220567

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

January 5, 2020

Last Update Submit

March 6, 2020

Conditions

Fibromyalgia

Keywords

FibromyalgiaExercisePatient-centred EducationRandomised Controlled Trial

Outcome Measures

Primary Outcomes (8)

  • Pain intensity

    Measured using the Numeric Pain Rating Scale, NPS, 0-10

    Baseline

  • Pain intensity

    Measured using the Numeric Pain Rating Scale, NPS, 0-10

    4 weeks

  • Pain intensity

    Measured using the Numeric Pain Rating Scale, NPS, 0-10

    8 weeks

  • Pain intensity

    Measured using the Numeric Pain Rating Scale, NPS, 0-10

    Follow-up 3 months

  • Disability and Impact of Fibromyalgia

    Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

    Baseline

  • Disability and Impact of Fibromyalgia

    Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

    4 weeks

  • Disability and Impact of Fibromyalgia

    Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

    8 weeks

  • Disability and Impact of Fibromyalgia

    Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

    Follow-up 3 months

Secondary Outcomes (8)

  • Neuropathic components in pain

    Baseline

  • Health-related Quality of Life

    Baseline

  • Health-related Quality of Life

    4 weeks

  • Health-related Quality of Life

    8 weeks

  • Health-related Quality of Life

    Follow-up 3 months

  • +3 more secondary outcomes

Study Arms (2)

Exercise and Patient-centred education

EXPERIMENTAL
Other: Experimental: Exercise and Patient-centred education

Exercise

ACTIVE COMPARATOR
Other: Active Comparator: Exercise

Interventions

Experimental: Exercise and Patient-centred educationOTHER

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 and Patient-centred education
Active Comparator: ExerciseOTHER

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).

Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmen Caeiro

Setúbal, 2914-503, Portugal

RECRUITING

MeSH Terms

Conditions

FibromyalgiaMotor Activity

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

January 7, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

PT(1)