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

ISRCTN	ISRCTN53367487
DOI	https://doi.org/10.1186/ISRCTN53367487
Protocol serial number	18/02
Sponsor	University of Extremadura (Spain)
Funder	Health Department of Junta de Extremadura (Spain)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	AF8PF/18/02
Study objectives	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(s)	Bioethical Committee of the University of Extremadura on 11/07/2002, reference number 18/02
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Phychological aspects: state trait anxiety inventory
Completion date	01/06/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	33
Key inclusion criteria	Women who suffer fibromyalgia according to diagnosis by the American College of Rheumatism
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	01/10/2004
Date of final enrolment	01/06/2005

Faculty of Sports Sciences

Caceres
10071
Spain

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

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