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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: Mind-body exercise
    Exercise program.
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.
  • Other: Light mobility exercises
    Modified mind-body program.
No Intervention
Healthy Controls
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Caio Sarmento
cmessiassarmento@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Caio Sarmento, PT
(913) 588-4565
cmessiassarmento@kumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.