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Qigong Exercise May Benefit Patients With Fibromyalgia

NCT01333566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-07-04

No results posted yet for this study

Summary

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.

Conditions

  • Fibromyalgia

Interventions

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.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Wen Liu, PhD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01333566 on ClinicalTrials.gov