The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2019
CompletedJanuary 4, 2019
January 1, 2019
1.5 years
February 15, 2018
January 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Change in Pittsburgh Sleep Quality Index (PSQI)
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Pressure Pain Threshold (PPT)
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Fibromyalgia Impact Questionnaire (FIQR)
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)
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Study Arms (3)
Full mind-body exercises
EXPERIMENTALParticipants 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.
Light mobility exercises: Control Group
ACTIVE COMPARATORThe 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.
Healthy Controls
NO INTERVENTIONHealthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (1)
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.
PMID: 32455108DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen Liu, PhD
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2018
First Posted
February 22, 2018
Study Start
February 1, 2018
Primary Completion
July 17, 2019
Study Completion
December 20, 2019
Last Updated
January 4, 2019
Record last verified: 2019-01