FibromyalgiaNCT04220567
Effectiveness of Exercise and Patient-centred Education on Fibromyalgia
A study testing Experimental: Exercise and Patient-centred education and Active Comparator: Exercise in people with Fibromyalgia, run by Instituto Politécnico de Setúbal. Escola Superior de Saúde. at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Experimental: Exercise and Patient-centred education and Active Comparator: Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Jan 2020to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Carmen Caeiro
Setúbal, 2914-503
Carmen Caeiro, PhD, 00351 265 709 382 ext. 5382, carmen.caeiro@ess.ips.pt
Patrícia Falcão, BSc Hons, 00351 265 709 382 ext. 5382, patricia.falcao@ess.ips.pt
About this study
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
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.
- Conditions
- Fibromyalgia
- Being tested
- Experimental: Exercise and Patient-centred education, Active Comparator: Exercise
- Keywords
- Fibromyalgia, Exercise, Patient-centred Education, Randomised Controlled Trial
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Patient-centred education | Experimental | Not described Receives: Other: Experimental: Exercise and Patient-centred education |
| Exercise | Active comparator | Not described Receives: Other: Active Comparator: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Measured: Baseline
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Measured: 4 weeks
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Measured: 8 weeks
Pain intensity
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Measured: Follow-up 3 months
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Measured: Baseline
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Measured: 4 weeks
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Measured: 8 weeks
Disability and Impact of Fibromyalgia
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Measured: Follow-up 3 months
Secondary outcomes (8)
Neuropathic components in pain
Measured using the painDETECT Questionnaire
Measured: Baseline
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Measured: Baseline
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Measured: 4 weeks
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Measured: 8 weeks
Health-related Quality of Life
Measured using the EuroQol 5D 3L, EQ 5D-3L
Measured: Follow-up 3 months
Patients' perception of improvement or decline in clinical status
Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7
Measured: 4 weeks
Patients' perception of improvement or decline in clinical status
Measured using the Patient Global Impression of Change Scale, PGIC, 1-7
Measured: 8 weeks
Patients' perception of improvement or decline in clinical status
Measured using the Patient Global Impression of Change Scale, PGIC, 1-7
Measured: Follow-up 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start7 Jan 2020
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Setúbal. Escola Superior de Saúde.
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220567
- Sponsor's protocol ID
- IPSetubalESS_SHARE
- Status last verified
- Mar 2020
- First submitted
- 5 Jan 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04220567
- Acronym / sponsor ID
- IPSetubalESS_SHARE
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Exercise, Patient-centred Education, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Politécnico de Setúbal. Escola Superior de Saúde.University, hospital or other
- 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
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Exercise and Patient-centred education | Experimental | Other: Experimental: Exercise and Patient-centred education |
| Exercise | Active comparator | Other: Active Comparator: Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Exercise and Patient-centred educationAn 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 | Other | Exercise and Patient-centred education |
| Active Comparator: ExerciseAn 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). | Other | Exercise |
Primary outcome
Pain intensity
Time frame: Baseline
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Pain intensity
Time frame: 4 weeks
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Pain intensity
Time frame: 8 weeks
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Pain intensity
Time frame: Follow-up 3 months
Measured using the Numeric Pain Rating Scale, NPS, 0-10
Disability and Impact of Fibromyalgia
Time frame: Baseline
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Disability and Impact of Fibromyalgia
Time frame: 4 weeks
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Disability and Impact of Fibromyalgia
Time frame: 8 weeks
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
Disability and Impact of Fibromyalgia
Time frame: Follow-up 3 months
Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100
8 secondary outcomes
Neuropathic components in pain
Time frame: Baseline
Health-related Quality of Life
Time frame: Baseline
Health-related Quality of Life
Time frame: 4 weeks
Health-related Quality of Life
Time frame: 8 weeks
Health-related Quality of Life
Time frame: Follow-up 3 months
Patients' perception of improvement or decline in clinical status
Time frame: 4 weeks
Patients' perception of improvement or decline in clinical status
Time frame: 8 weeks
Patients' perception of improvement or decline in clinical status
Time frame: Follow-up 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Exercise and Patient-centred education and Active Comparator: Exercise in people with Fibromyalgia, run by Instituto Politécnico de Setúbal. Escola Superior de Saúde. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.