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

University of Kansas

Status: Unknown

Conditions: Fibromyalgia

Treatments: Other: Mind-body exercise; Other: Light mobility exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT03441997

STUDY00141263

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Full mind-body exercises

Experimental group

Description:

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.

Treatment:

Other: Mind-body exercise

Light mobility exercises: Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Light mobility exercises

Healthy Controls

No Intervention group

Description:

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