The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention

Not Applicable

• Conditions: Fibromyalgia
• Interventions: Other: Mind-body exercise; Other: Light mobility exercises

• Registration Number: NCT03441997
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to compare two different exercise programs to see if there are differences after exercise in fibromyalgia (FM) symptoms and responses from the immune system.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-22
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04
• Primary Completion: 2019-07-17
• Study Completion: 2019-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full mind-body exercises	Mind-body exercise	Participants will be trained to perform a type of mind-body exercise that involves low intensity exercise and body movements similar to Tai Chi. Participants will be asked to exercise 2 times per day for 8 weeks.
Light mobility exercises: Control Group	Light mobility exercises	The Light mobility exercises group will perform a similar exercise as the experimental group. However without a few components. Participants will be asked to exercise two times per day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)	At three time points: before exercise, at the maximum exertion, and 30 minutes after maximum exertion. This procedure will be conducted at baseline and after 8 weeks of qigong/sham-qigong practice.	Changes will be measured during a bout of exhaustive exercise using a recumbent bicycle machine

Secondary Outcome Measures

Name	Time	Method
Change in Pittsburgh Sleep Quality Index (PSQI)	At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention	Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSIQ), which was designed to differentiate between good and poor sleepers. The PSIQ covers subjective sleep quality, sleep latency, sleep disturbances, sleep duration, daytime dysfunction and use of sleep medications. It consists of 19 self-rated questions. The PSIQ has been vastly employed in clinical trials, and it has been reported to be reliable and valid
Change in Pressure Pain Threshold (PPT)	At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention	Pressure pain threshold is defined as the minimum force applied which induces pain. Mechanical pressure, determined as a kilogram (kg) per 1 cm2 of skin on the sensitive areas, is applied by a Fisher's hand dolorimeter. The examiner places the rubber tip on the examination site and gradually increases the pressure at a rate of approximately 1 kg per second. Subjects are instructed to say ''yes'' when the sensation of pressure causes pain and the pain pressure threshold is recorded. Pain threshold is measured in the 18 points specified by the American College of Rheumatology.
Change in Fibromyalgia Impact Questionnaire (FIQR)	At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention	This questionnaire can capture the total spectrum of issues related to FM and the patient's response to therapies. It is one of the most used instrument in trials involving subjects with FM. Also, it has been proven to show consistent response to clinical changes
Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)	At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention	This scale is one of the most used instrument to measure quality of life in patients with chronic disease. The QOLS is a 15-item questionnaire that accesses five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. This scale has been shown to be reliable and validated by previous studies

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States