Comparative effect of two supervised exercise programs on key health outcomes in women with fibromyalgia syndrome

ISRCTN	ISRCTN43742447
DOI	https://doi.org/10.1186/ISRCTN43742447
Protocol serial number	N/A
Sponsor	University of Seville (Spain)
Funder	University of Seville (Spain) - Research grant from Facultad de Ciencias de la Educación

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

Facultad de Ciencias de la Educación.
Avda. Ciudad Jardín nº 20-22
Seville
41005
Spain

Email	bsancor@us.es

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	10/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	54
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes