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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03441997
• Other study ID #: STUDY00141263
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2019
• Source: University of Kansas Medical Center
• Contact: Caio Sarmento, PT
• Phone: (913) 588-4565
• Email: cmessiassarmento[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 20, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Mind-body exercise
Exercise program.
• Light mobility exercises
Modified mind-body program.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)	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	Change in Pittsburgh Sleep Quality Index (PSQI)	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
Secondary	Change in Pressure Pain Threshold (PPT)	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
Secondary	Change in Fibromyalgia Impact Questionnaire (FIQR)	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
Secondary	Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)	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