Contact information
Type
Scientific
Primary contact
Dr Borja Sañudo
ORCID ID
Contact details
Facultad de Ciencias de la Educación.
Avda. Ciudad Jardín nº 20-22
Seville
41005
Spain
bsancor@us.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome: a randomised controlled trial
Acronym
Study hypothesis
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
University of Seville Ethics Board approved on the 22nd January 2007
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2007
Overall trial end date
10/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged above 18 years
2. Met the American College of Rheumatology (ACR) criteria for classification of fibromyalgia
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Sample size calculations indicated that a total of 54 participants (18 per group) were needed
Participant 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
Recruitment start date
01/09/2007
Recruitment end date
10/12/2009
Locations
Countries of recruitment
Spain
Trial participating centre
Facultad de Ciencias de la Educación.
Seville
41005
Spain
Sponsor information
Organisation
University of Seville (Spain)
Sponsor details
Dpto. Educación Física y Deporte
Facultad de Ciencias de la Educación
Avenida Ciudad Jardin
20-22
Sevilla
E - 41005
Spain
+ 34 95 45 56 209
bsancor@us.es
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Seville (Spain) - Research grant from Facultad de Ciencias de la Educación
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list