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| Name | Class |
|---|---|
| Universidade de Lisboa - Faculdade Letras | UNKNOWN |
| Centro Hospitalar de Setúbal E.P.E. | UNKNOWN |
| Centro Hospitalar Lisboa Ocidental | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and Patient-centred education | Experimental |
| |
| Exercise | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Exercise and Patient-centred education | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropathic components in pain | Measured using the painDETECT Questionnaire | Baseline |
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carmen Caeiro | Recruiting | Setúbal | 2914-503 | Portugal |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica |
| UNKNOWN |
Parallel assignment
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Double blind
|
| Active Comparator: Exercise | Other | 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). |
|
| Baseline |
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | 4 weeks |
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | 8 weeks |
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | 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 | 4 weeks |
| Patients' perception of improvement or decline in clinical status | Measured using the Patient Global Impression of Change Scale, PGIC, 1-7 | 8 weeks |
| Patients' perception of improvement or decline in clinical status | Measured using the Patient Global Impression of Change Scale, PGIC, 1-7 | Follow-up 3 months |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |