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

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ClinicalTrials.gov Identifier: NCT03441997
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Mind-body exercise Other: Light mobility exercises Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : July 17, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441997


Contacts
Contact: Caio Sarmento, PT (913) 588-4565 cmessiassarmento@kumc.edu
Contact: Taylor Pfeifer (913) 588-4565 t009p412@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Caio Sarmento       cmessiassarmento@kumc.edu   
Contact: Taylor Pfeifer    785-656-3356      
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Principal Investigator: Wen Liu, PhD University of Kansas Medical Center

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03441997     History of Changes
Other Study ID Numbers: STUDY00141263
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
exercise
low intensity exercise
pain
fatigue
sleep problems

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases