Clinical Trial Finder

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03441997
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Kansas Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Wen Liu, PhD
Principal Investigator Affiliation University of Kansas Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Fibromyalgia
Arms & Interventions

Arms

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.

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.

No Intervention: Healthy Controls

Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.

Interventions

Other: - Mind-body exercise

Exercise program.

Other: - Light mobility exercises

Modified mind-body program.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Caio Sarmento

[email protected]

(913) 588-4565

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