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Qigong Exercise May Benefit Patients With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Kansas.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Wen Liu, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01333566
First received: April 8, 2011
Last updated: June 4, 2012
Last verified: June 2012

April 8, 2011
June 4, 2012
July 2009
July 2012   (final data collection date for primary outcome measure)
To investigate the effect of qigong exercise on pain [ Time Frame: up to 3months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01333566 on ClinicalTrials.gov Archive Site
  • To investigate the effect of qigong exercise on fatigue [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • To investigate the effect of qigong exercise on sleep quality [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • To investigate the effect of qigong exercise the quality of life in FM patients. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Qigong Exercise May Benefit Patients With Fibromyalgia
Qigong Exercise May Benefit Patients With Fibromyalgia

The long-term goal of our research program is to develop an effective and cost-saving mind-body therapy to help patients with FM. The objective of this pilot study is to gather pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients using a specific type of qigong exercise, i.e. "six healing sound" qigong. Changes in relevant brain activity will be monitored in study subjects before and after the qigong exercise program, which may help us in better understanding the underlying mechanism of the qigong exercise. Data collected in this pilot study will help the investigators in preparation for a future clinical trial with a larger sample size. Our central hypothesis for the future clinical trial is that qigong exercise will lead to a significantly greater improvement in pain, fatigue, sleep quality, and quality of life in the experimental group compared to the control group.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
  • Behavioral: Intervention Group
    The study will include one week baseline phase, 6-week intervention phase, and a 3-month follow-up evaluation. Subjects in the intervention group will go through three training sessions during the baseline phase, weekly group exercise sessions once per week and daily home exercises two times each day during the intervention phase, and a follow-up evaluation in three months after the intervention phase.
  • Behavioral: Placebo Comparator: Control Group
    Subjects in the control group will be monitored during the baseline and intervention phase without participating in the interventional exercise. At the end of intervention phase, the subjects will have the option to stop their participation or switch to the intervention group.
  • Experimental: Intervention Group
    Intervention: Behavioral: Intervention Group
  • Placebo Comparator: Control Group
    Intervention: Behavioral: Placebo Comparator: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a diagnosis of primary FM, based on the 1990 American College of Rheumatology criteria (Wolfe et al, 1990),
  • between the ages of 18 and 70 years;
  • willing to withdraw from CNS-active therapies commonly used to treat FM; willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender- and trigger-point injections, acupuncture, and anesthetic or narcotic patches;
  • with a raw score > 4 on the physical function component of the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt et al, 1991);
  • and a mean visual analog scale (VAS) pain score > 40 on a scale from 0 to 100.

Exclusion Criteria:

  • severe psychiatric illness;
  • a current major depressive episode (as determined by a Beck Depression Inventory (Beck et al, 1961) score >25);
  • significant suicide risk;
  • abuse of alcohol, benzodiazepines, or other drugs; a history of behavior that would prohibit compliance for the duration of the study;
  • active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that had been stable for 3 months before screening);
  • current systemic infection; active cancer (except basal cell carcinoma); unstable endocrine disease; severe sleep apnea;
  • prostate enlargement or other genitourinary disorder (male patients);
  • or pregnancy or breastfeeding (female patients).
Both
18 Years to 80 Years
No
Contact: Wen Liu, PhD 913-588-4565 wliu@kumc.edu
United States
 
NCT01333566
11889
No
Wen Liu, Ph.D., University of Kansas Medical Center Research Institute
Wen Liu, Ph.D.
Not Provided
Principal Investigator: Wen Liu, PhD University of Kansas
University of Kansas
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP