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Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Experimental: Exercise and Patient-centred education
Active Comparator: Exercise
Sponsored by
Instituto Politécnico de Setúbal. Escola Superior de Saúde.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Exercise, Patient-centred Education, Randomised Controlled Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Carmen CaeiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and Patient-centred education

Exercise

Arm Description

Outcomes

Primary Outcome Measures

Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

Secondary Outcome Measures

Neuropathic components in pain
Measured using the painDETECT Questionnaire
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Patients' perception of improvement or decline in clinical status
Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7
Patients' perception of improvement or decline in clinical status
Measured using the Patient Global Impression of Change Scale, PGIC, 1-7
Patients' perception of improvement or decline in clinical status
Measured using the Patient Global Impression of Change Scale, PGIC, 1-7

Full Information

First Posted
January 5, 2020
Last Updated
March 6, 2020
Sponsor
Instituto Politécnico de Setúbal. Escola Superior de Saúde.
Collaborators
Universidade de Lisboa - Faculdade Letras, Centro Hospitalar de Setúbal E.P.E., Centro Hospitalar Lisboa Ocidental, Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica
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1. Study Identification

Unique Protocol Identification Number
NCT04220567
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Politécnico de Setúbal. Escola Superior de Saúde.
Collaborators
Universidade de Lisboa - Faculdade Letras, Centro Hospitalar de Setúbal E.P.E., Centro Hospitalar Lisboa Ocidental, Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Exercise, Patient-centred Education, Randomised Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and Patient-centred education
Arm Type
Experimental
Arm Title
Exercise
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Experimental: Exercise and Patient-centred education
Intervention Description
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
Intervention Name(s)
Active Comparator: Exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain intensity
Description
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Time Frame
Baseline
Title
Pain intensity
Description
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Time Frame
4 weeks
Title
Pain intensity
Description
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Time Frame
8 weeks
Title
Pain intensity
Description
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Time Frame
Follow-up 3 months
Title
Disability and Impact of Fibromyalgia
Description
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Time Frame
Baseline
Title
Disability and Impact of Fibromyalgia
Description
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Time Frame
4 weeks
Title
Disability and Impact of Fibromyalgia
Description
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Time Frame
8 weeks
Title
Disability and Impact of Fibromyalgia
Description
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Time Frame
Follow-up 3 months
Secondary Outcome Measure Information:
Title
Neuropathic components in pain
Description
Measured using the painDETECT Questionnaire
Time Frame
Baseline
Title
Health-related Quality of Life
Description
Measured using the EuroQol 5D 3L, EQ 5D-3L
Time Frame
Baseline
Title
Health-related Quality of Life
Description
Measured using the EuroQol 5D 3L, EQ 5D-3L
Time Frame
4 weeks
Title
Health-related Quality of Life
Description
Measured using the EuroQol 5D 3L, EQ 5D-3L
Time Frame
8 weeks
Title
Health-related Quality of Life
Description
Measured using the EuroQol 5D 3L, EQ 5D-3L
Time Frame
Follow-up 3 months
Title
Patients' perception of improvement or decline in clinical status
Description
Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7
Time Frame
4 weeks
Title
Patients' perception of improvement or decline in clinical status
Description
Measured using the Patient Global Impression of Change Scale, PGIC, 1-7
Time Frame
8 weeks
Title
Patients' perception of improvement or decline in clinical status
Description
Measured using the Patient Global Impression of Change Scale, PGIC, 1-7
Time Frame
Follow-up 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Carmen Caeiro
City
Setúbal
ZIP/Postal Code
2914-503
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Caeiro, PhD
Phone
00351 265 709 382
Ext
5382
Email
carmen.caeiro@ess.ips.pt
First Name & Middle Initial & Last Name & Degree
Patrícia Falcão, BSc Hons
Phone
00351 265 709 382
Ext
5382
Email
patricia.falcao@ess.ips.pt

12. IPD Sharing Statement

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Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

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