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ISRCTN
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ISRCTN43742447
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ClinicalTrials.gov identifier
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Public title
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Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome
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Scientific title
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Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome: a randomised controlled trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Lay summary
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Ethics approval
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University of Seville Ethics Board approved on the 22nd January 2007
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Fibromyalgia syndrome
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Participants - inclusion criteria
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1. Women aged above 18 years
2. Met the American College of Rheumatology (ACR) criteria for classification of fibromyalgia
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2007
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Anticipated end date
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10/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Sample size calculations indicated that a total of 54 participants (18 per group) were needed
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Interventions
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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).
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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University of Seville (Spain) - Research grant from Facultad de Ciencias de la Educación
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Trial website
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Publications
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Contact name
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Dr
Borja
Sañudo
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Address
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Facultad de Ciencias de la Educación.
Avda. Ciudad Jardín nº 20-22
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City/town
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Seville
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Zip/Postcode
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41005
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Country
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Spain
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Email
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bsancor@us.es
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Sponsor
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University of Seville (Spain)
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Address
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Dpto. Educación Física y Deporte
Facultad de Ciencias de la Educación
Avenida Ciudad Jardin, 20-22
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City/town
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Sevilla
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Zip/Postcode
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E - 41005
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Country
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Spain
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Tel
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+ 34 95 45 56 209
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Email
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bsancor@us.es
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Sponsor website:
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http://www.us.es/
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Date applied
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09/12/2009
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Last edited
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21/12/2009
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Date ISRCTN assigned
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21/12/2009
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