Condition category
Musculoskeletal Diseases
Date applied
09/12/2009
Date assigned
21/12/2009
Last edited
21/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.us.es/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes