Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome
ISRCTN | ISRCTN43742447 |
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DOI | https://doi.org/10.1186/ISRCTN43742447 |
Secondary identifying numbers | N/A |
- Submission date
- 09/12/2009
- Registration date
- 21/12/2009
- Last edited
- 21/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Borja Sañudo
Scientific
Scientific
Facultad de Ciencias de la Educación.
Avda. Ciudad Jardín nº 20-22
Seville
41005
Spain
bsancor@us.es |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome: a randomised controlled trial |
Study objectives | 1. A 24-week exercise programme based on a combination of aerobic exercise, muscle strengthening and flexibility, has a more positive impact on fibromyalgia syndrome (FS) specific symptomatology than one based exclusively on aerobic exercise, regardless of their initial level of impairment 2. A 24-week exercise programme based on a combination of aerobic exercise, muscle strengthening and flexibility has a more positive impact on physical fitness in women with FS than one based exclusively on aerobic exercise |
Ethics approval(s) | University of Seville Ethics Board approved on the 22nd January 2007 |
Health condition(s) or problem(s) studied | Fibromyalgia syndrome |
Intervention | Group A: Patients performed two aerobic exercise sessions per week, which included a 10 minute warm up, 25 - 30 minutes at 60 - 65% HRmax and interval training at 75 - 80% HRmax and finally 5 - 10 minutes cool-down. Group B: Patients performed twice-weekly sessions of combined aerobic and muscle strength training exercises, including 10 minutes warm up, 10 - 15 minutes of aerobic exercise at 65 - 70% HRmax, 15 - 20 minutes of muscle training on 8 exercises (1 set of 8 - 10 reps with 1 - 3 kg) and finally 10 minutes of flexibility training on 8 - 9 exercises (1 set of 3 reps keeping the stretched position for 30 seconds). Group C: Patients continued their normal daily activities during the period of the intervention. Patients were assessed at 24 weeks (end of intervention period). |
Intervention type | Other |
Primary outcome measure | 1. Health status: the Fibromyalgia Impact Questionnaire (FIQ) and The Medical Outcomes Study Short Form (SF-36) health survey 2. Physical fitness: the six-minute walk test was used to estimate aerobic capacity, hand-grip strength and range of motion (flexion/extension) in the shoulders and hips Assessment of all outcomes was undertaken at baseline and immediately after the 24-week intervention and at the same time points in the usual care control group. |
Secondary outcome measures | Depression was assessed using the Beck Depression Inventory (BDI). Assessment of all outcomes was undertaken at baseline and immediately after the 24-week intervention and at the same time points in the usual care control group. |
Overall study start date | 01/09/2007 |
Completion date | 10/12/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | Sample size calculations indicated that a total of 54 participants (18 per group) were needed |
Key inclusion criteria | 1. Women aged above 18 years 2. Met the American College of Rheumatology (ACR) criteria for classification of fibromyalgia |
Key exclusion criteria | 1. Presence of inflammatory rheumatic diseases 2. Severe psychiatric illness 3. Respiratory or cardiovascular diseases that prevent physical loading 4. Women with FM who attended another psychological or physical therapy |
Date of first enrolment | 01/09/2007 |
Date of final enrolment | 10/12/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Facultad de Ciencias de la Educación.
Seville
41005
Spain
41005
Spain
Sponsor information
University of Seville (Spain)
University/education
University/education
Dpto. Educación Física y Deporte
Facultad de Ciencias de la Educación
Avenida Ciudad Jardin, 20-22
Sevilla
E - 41005
Spain
Phone | + 34 95 45 56 209 |
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bsancor@us.es | |
Website | http://www.us.es/ |
https://ror.org/03yxnpp24 |
Funders
Funder type
University/education
University of Seville (Spain) - Research grant from Facultad de Ciencias de la Educación
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |