Contact information
Type
Scientific
Primary contact
Prof Narcis Gusi
ORCID ID
Contact details
Faculty of Sports Sciences
Avda Universidad s/n
Caceres
10071
Spain
+34 (0)92 725 74 60
ngusi@unex.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18/02
Study information
Scientific title
Acronym
AF8PF/18/02
Study hypothesis
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
Bioethical Committee of the University of Extremadura on 11/07/2002, reference number 18/02
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2004
Overall trial end date
01/06/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatism
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
33 distributed in two groups
Participant exclusion criteria
1. Contraindications to physical exercise
2. Other physical or psychological therapies
3. Cognitive disease
4. Drugs affecting the measures
Recruitment start date
01/10/2004
Recruitment end date
01/06/2005
Locations
Countries of recruitment
Spain
Trial participating centre
Faculty of Sports Sciences
Caceres
10071
Spain
Sponsor information
Organisation
University of Extremadura (Spain)
Sponsor details
Avda Elvas s/n
Badajoz
Caceres
06071
Spain
+34 (0)92 428 93 05
vicein@unex.es
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Department of Junta de Extremadura (Spain)
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
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18294367
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19605373
Publication citations
-
Results
Gusi N, Tomas-Carus P, Cost-utility of an 8-month aquatic training for women with fibromyalgia: a randomized controlled trial., Arthritis Res. Ther., 2008, 10, 1, R24, doi: 10.1186/ar2377.
-
Results
Tomas-Carus P, Gusi N, Häkkinen A, Häkkinen K, Raimundo A, Ortega-Alonso A, Improvements of muscle strength predicted benefits in HRQOL and postural balance in women with fibromyalgia: an 8-month randomized controlled trial., Rheumatology (Oxford), 2009, 48, 9, 1147-1151, doi: 10.1093/rheumatology/kep208.