NCT00600574

Brief Summary

The purpose of the study is to compare the efficacy and tolerability of Ai Chi, an adaptation of Tai Chi exercise to water, with stretching on fibromyalgia symtomatology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

1.1 years

First QC Date

January 14, 2008

Last Update Submit

December 1, 2014

Conditions

Fibromyalgia

Keywords

fibromyalgiaphysical therapiesstretchingAi Chi

Outcome Measures

Primary Outcomes (1)

  • Fibromialgya Impact Questionnaire

    baseline, 6 months, 1 year

Secondary Outcomes (5)

  • Pittsbugh Sleep Quality Index

    baseline, 6 months, 12 months

  • Hospital Anxiety and Depression Scale

    baseline, 6 months, 12 months

  • SF-36 Health Survey

    baseline, 6 months, 12 months

  • Brief Pain Inventory

    baseline, 6 months, 12 months

  • Adverse reaction recording

    baseline, 6 months, 12 months

Study Arms (2)

S

ACTIVE COMPARATOR

physiotherapy in warm pool by means of stretching

Other: physical therapy

AI

EXPERIMENTAL

physiotherapy in warm pool by means of Ai Chi

Other: physical therapy

Interventions

physical therapyOTHER

weekly pool physiotherapy with muscle stretching

Also known as: physiotherapy
S

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of fibromyalgia according to the ACR criteria
  • years or older
  • written informed consent to participate

You may not qualify if:

  • unable to tolerate warm chlorinated water
  • associated medical condition contraindicating exercise in warm water

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Virgen de las Nieves"

Granada, Granada, 18014, Spain

Location

Related Publications (1)

  • Gowans SE, deHueck A. Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar;19(2):168-73. doi: 10.1097/BOR.0b013e3280327944.

    PMID: 17278933BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Elena P. Calandre, M.D.

    Universidad de Granada

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacology

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

January 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

ES(1)