Back to resultsPool-based Exercise in Fibromyalgia Management
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
physical therapy
physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, pool-based exercise
Eligibility Criteria
Inclusion Criteria:
- diagnosis of fibromyalgia according to the ACR criteria
- 18 years or older
- written informed consent to participate
Exclusion Criteria:
- unable to tolerate warm chlorinated water
- associated medical condition contraindicating exercise in warm water
Sites / Locations
- Hospital Universitario "Virgen de las Nieves"
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Improvement in fibromyalgia symptomatology
Secondary Outcome Measures
Improvement in sleep, depressive and anxiety symptomatology and quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00550641
Brief Title
Pool-based Exercise in Fibromyalgia Management
Official Title
Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, pool-based exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
physical therapy in warm pool performing stretching
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
physical therapy in warm pool performing Ai Chi
Primary Outcome Measure Information:
Title
Improvement in fibromyalgia symptomatology
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Improvement in sleep, depressive and anxiety symptomatology and quality of life
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of fibromyalgia according to the ACR criteria
18 years or older
written informed consent to participate
Exclusion Criteria:
unable to tolerate warm chlorinated water
associated medical condition contraindicating exercise in warm water
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena P. Calandre
Organizational Affiliation
Professor of Clinical Pharmacology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mª Luz Rodriguez-Claro
Organizational Affiliation
physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Virgen de las Nieves"
City
Granada
ZIP/Postal Code
18012
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
20074435
Citation
Calandre EP, Rodriguez-Claro ML, Rico-Villademoros F, Vilchez JS, Hidalgo J, Delgado-Rodriguez A. Effects of pool-based exercise in fibromyalgia symptomatology and sleep quality: a prospective randomised comparison between stretching and Ai Chi. Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S21-8.
Results Reference
result
Learn more about this trial
Pool-based Exercise in Fibromyalgia Management
We'll reach out to this number within 24 hrs