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

January 3, 2019 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria for FM Patients:

  • Patients with a diagnosis of FM
  • Clearance from patient's physician to participate in a clinical trial
  • Not participating or willing to discontinue FM treatment with trans-cutaneous electrical nerve stimulation, biofeedback, tender-point injections, acupuncture, Yoga, and Tai Chi.

Exclusion Criteria for all Participants:

  • Diagnosis of severe psychiatric illness
  • Abuse of alcohol, benzodiazepines, or other drugs
  • Active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that has 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)
  • Pregnancy or breastfeeding

Inclusion Criteria for Healthy Controls:

  • Female
  • No apparent medical condition that will interfere with participation in the study
  • Not on any medication that will interfere with participation in this study

Exclusion Criteria for Healthy Controls:

  • Medical or surgical conditions including medication that preclude participation in the study
  • Presence of motor or neuromuscular deficits that may preclude participating in fatigue exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full mind-body exercises
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.
Other: Mind-body exercise
Exercise program.
Active Comparator: Light mobility exercises: Control Group
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.
Other: Light mobility exercises
Modified mind-body program.
No Intervention: Healthy Controls
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
Time Frame: 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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Pressure Pain Threshold (PPT)
Time Frame: 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.
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Fibromyalgia Impact Questionnaire (FIQR)
Time Frame: 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
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)
Time Frame: 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
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Wen Liu, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

July 17, 2019

Study Completion (Anticipated)

December 20, 2019

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00141263

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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