Pool-based Exercise in Fibromyalgia Management | NCT00550641

Studies
Pool-based Exercise in Fibromyalgia Management

NCT00550641

Sponsor

Universidad de Granada

Status

Completed

Last Update Posted

Apr 6, 2010Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Fibromyalgia

Interventions

physical therapy
physical therapy

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Oct 26, 2007

First Submission Date that Met QC Criteria

Oct 26, 2007

First Posted Date

Oct 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2010

Last Update Posted Date

Apr 6, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Other: physical therapy
2	Experimental		Other: physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical therapy	Other	physical therapy in warm pool performing stretching	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement in fibromyalgia symptomatology		18 weeks

Secondary Outcomes

Measure	Description	Time Frame
Improvement in sleep, depressive and anxiety symptomatology and quality of life		18 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elena P. Calandre	Professor of Clinical Pharmacology	Study Director
Mª Luz Rodriguez-Claro	physiotherapist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario "Virgen de las Nieves"		Granada	Granada	18012	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20074435	Result	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.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

ID	Term
D013812	Therapeutics
D012046	Rehabilitation