Condition category
Musculoskeletal Diseases
Date applied
18/06/2006
Date assigned
14/07/2006
Last edited
20/07/2009
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

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

http://www.unex.es

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

  1. 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.

  2. 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.

Additional files

Editorial Notes