Clinical trial NCT03441997: The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
Official title: The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: exercise
low intensity exercise
pain
fatigue
sleep problems
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
timeFrame: 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 outcomes:
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
measure: Change in Pressure Pain Threshold (PPT)
timeFrame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
measure: Change in Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
measure: Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)
timeFrame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarmento CVM, Moon S, Pfeifer T, Smirnova IV, Colgrove Y, Lai SM, Liu W. The therapeutic efficacy of Qigong exercise on the main symptoms of fibromyalgia: A pilot randomized clinical trial. Integr Med Res. 2020 Dec;9(4):100416. doi: 10.1016/j.imr.2020.100416. Epub 2020 Apr 25.