Effects of an eight-month aquatic exercise programme in women with fibromyalgia

ISRCTN ISRCTN53367487
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

Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain

Phone +34 (0)92 725 74 60
Email ngusi@unex.es

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymAF8PF/18/02
Study objectives1. 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) studiedFibromyalgia
InterventionAquatic 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 typeOther
Primary outcome measure1. 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 measuresPhychological aspects: state trait anxiety inventory
Overall study start date01/10/2004
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants33 distributed in two groups
Key inclusion criteriaWomen who suffer fibromyalgia according to diagnosis by the American College of Rheumatism
Key exclusion criteria1. Contraindications to physical exercise
2. Other physical or psychological therapies
3. Cognitive disease
4. Drugs affecting the measures
Date of first enrolment01/10/2004
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • Spain

Study participating centre

Faculty of Sports Sciences
Caceres
10071
Spain

Sponsor information

University of Extremadura (Spain)
University/education

Avda Elvas s/n
Badajoz
Caceres
06071
Spain

Phone +34 (0)92 428 93 05
Email vicein@unex.es
Website http://www.unex.es
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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