NCT02257034

Brief Summary

To evaluate the effect of Tai chi on Fibromyalgia

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

8.3 years

First QC Date

October 2, 2014

Last Update Submit

March 31, 2017

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Impact Questionnaire (FIQ)

    up to 48 weeks

Study Arms (2)

Taichi

EXPERIMENTAL

patients exercise with Tai chi

Other: Taichi

Control

SHAM COMPARATOR

patients under exercise of dance

Other: Dance

Interventions

TaichiOTHER
Taichi
DanceOTHER
Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • meeting the classification of FM per the 1990 ACR criteria
  • approval by a healthcare provider for participation

You may not qualify if:

  • had practiced Tai chi within the past 6 months
  • had exercised \>30 min three times weekly for past 3 months
  • could not independently ambulate without assistive devices
  • had BPI pain severity or interference scores less than 5
  • had planned elective surgery during study period
  • were actively involved in health-related litigation
  • were unwilling to keep all treatments/medications steady throughout the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, 610083, China

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CN(1)