Condition category
Musculoskeletal Diseases
Date applied
04/03/2006
Date assigned
20/04/2006
Last edited
05/11/2009
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
Caceres
10071
Spain
+34 (0)92 725 74 60
ngusi@unex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/02

Study information

Scientific title

Acronym

AFPFO/05/02

Study hypothesis

1. Physical activity enhances the
health related to quality of life and physical fitness
2. Aquatic training is a cost-effective strategy in persons with fibromyalgia

Ethics approval

Approved by the Bioethical Committee of University of Extremadura on 10/02/2002 ( ref: 05/02)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Fibromyalgia

Intervention

Patients are randomised to three groups:
Group 1: Aquatic training, 3 sessions per week for 3 months - 18 patients
Group 2: Usual care - 17 patients
Group 3: Land-based training, 3 sessions per week for 3 months - 30 patients

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Group 1 versus Group 2 = Isokinetic strength and electromyographic parameters, health related quality of life -Fibromyalgia Impact Questionnaire, EQ5D and SF-36 and its utilities to study cost-effectiveness, fitness, costs
Group 1 versus Group 3 = Health related quality of life -Fibromyalgia Impact Questionnaire, EQ5D and SF-36 and its utilities to study cost-effectiveness, fitness, costs
Group 2 versus Group 3 = Health related quality of life -Fibromyalgia Impact Questionnaire, EQ5D and SF-36 and its utilities to study cost-effectiveness, fitness, costs

Secondary outcome measures

Group 1 versus Group 2 = Psychological aspects - State Trait Anxiety Inventory
Group 1 versus Group 3 = Psychological aspects - State Trait Anxiety Inventory
Group 2 versus Group 3 = Psychological aspects - State Trait Anxiety Inventory

Overall trial start date

01/04/2004

Overall trial end date

01/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Women who suffer fibromyalgia according to American College of Rheumatism diagnosis

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

65 distributed in three 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

01/04/2004

Recruitment end date

01/10/2004

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
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

Publication citations

Additional files

Editorial Notes