Physical activity to persons with fibromyalgia and osteoporosis

ISRCTN	ISRCTN83162243
DOI	https://doi.org/10.1186/ISRCTN83162243
Protocol serial number	05/02
Sponsor	University of Extremadura (Spain)
Funder	Health Department of Junta de Extremadura (Spain)

Submission date: 04/03/2006
Registration date: 20/04/2006
Last edited: 05/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Narcis Gusi
Scientific

Faculty of Sports Sciences
Caceres
10071
Spain

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	AFPFO/05/02
Study objectives	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(s)	Approved by the Bioethical Committee of University of Extremadura on 10/02/2002 ( ref: 05/02)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/10/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	65
Key inclusion criteria	Women who suffer fibromyalgia according to American College of Rheumatism diagnosis
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	01/04/2004
Date of final enrolment	01/10/2004

Locations

Countries of recruitment

Spain

Study participating centre

Faculty of Sports Sciences

Caceres
10071
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan