Physical activity to persons with fibromyalgia and osteoporosis
| ISRCTN | ISRCTN83162243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83162243 |
| Secondary identifying numbers | 05/02 |
- 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
Scientific
Faculty of Sports Sciences
Caceres
10071
Spain
| Phone | +34 (0)92 725 74 60 |
|---|---|
| ngusi@unex.es |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| 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 | 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 study start date | 01/04/2004 |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 65 distributed in three groups |
| 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
10071
Spain
Sponsor information
University of Extremadura (Spain)
University/education
University/education
Avda Elvas s/n
Badajoz
06071
Spain
| Phone | +34 (0)92 428 93 05 |
|---|---|
| vicein@unex.es | |
| Website | http://www.unex.es |
"ROR" |
https://ror.org/0174shg90 |
Funders
Funder type
Government
Health Department of Junta de Extremadura (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
