Effects of an eight-month aquatic exercise programme in women with fibromyalgia
ISRCTN | ISRCTN53367487 |
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DOI | https://doi.org/10.1186/ISRCTN53367487 |
Secondary identifying numbers | 18/02 |
- Submission date
- 18/06/2006
- Registration date
- 14/07/2006
- Last edited
- 20/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Narcis Gusi
Scientific
Scientific
Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain
Phone | +34 (0)92 725 74 60 |
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ngusi@unex.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) | Not specified |
Study type | Treatment |
Scientific title | |
Study acronym | AF8PF/18/02 |
Study objectives | 1. Aquatic exercise improves the health-related quality of life and physical fitness 2. Aquatic training is a cost-effective strategy in persons with fibromyalgia |
Ethics approval(s) | Bioethical Committee of the University of Extremadura on 11/07/2002, reference number 18/02 |
Health condition(s) or problem(s) studied | Fibromyalgia |
Intervention | Aquatic training, three sessions per week for eight months In the eight-month fibromyalgia trial, there were two groups: 1. Control group: usual care (primary care based on antidepressants) without adding any physical or psychological therapy 2. Intervention group: we added three one-hour aquatic training sessions including: a. 4x12 knee flexo extension using body weight as charge b. 4x12 upper limb movements against the water drag using a pull-boy |
Intervention type | Other |
Primary outcome measure | 1. Pain as measured by the visual analogue scale (VAS) 2. EuroQol 5-D 3. Short-form-36 questionnaire (SF-36) scores 4. Utility and costs Isokinetic strength and electromyographic parameters Fibromyalgia Impact Questionnaire Fitness |
Secondary outcome measures | Phychological aspects: state trait anxiety inventory |
Overall study start date | 01/10/2004 |
Completion date | 01/06/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 33 distributed in two groups |
Key inclusion criteria | Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatism |
Key exclusion criteria | 1. Contraindications to physical exercise 2. Other physical or psychological therapies 3. Cognitive disease 4. Drugs affecting the measures |
Date of first enrolment | 01/10/2004 |
Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Faculty of Sports Sciences
Caceres
10071
Spain
10071
Spain
Sponsor information
University of Extremadura (Spain)
University/education
University/education
Avda Elvas s/n
Badajoz
Caceres
06071
Spain
Phone | +34 (0)92 428 93 05 |
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vicein@unex.es | |
Website | http://www.unex.es |
https://ror.org/0174shg90 |
Funders
Funder type
Government
Health Department of Junta de Extremadura (Spain)
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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/12/2008 | Yes | No | |
Results article | results | 01/09/2009 | Yes | No |