Status:
UNKNOWN
The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-70 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03441997
Start Date
February 1 2018
End Date
December 20 2019
Last Update
January 4 2019
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160