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

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-body exercise
Light mobility exercises
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring exercise, low intensity exercise, pain, fatigue, sleep problems

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Full mind-body exercises

Light mobility exercises: Control Group

Healthy Controls

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSIQ), which was designed to differentiate between good and poor sleepers. The PSIQ covers subjective sleep quality, sleep latency, sleep disturbances, sleep duration, daytime dysfunction and use of sleep medications. It consists of 19 self-rated questions. The PSIQ has been vastly employed in clinical trials, and it has been reported to be reliable and valid
Change in Pressure Pain Threshold (PPT)
Pressure pain threshold is defined as the minimum force applied which induces pain. Mechanical pressure, determined as a kilogram (kg) per 1 cm2 of skin on the sensitive areas, is applied by a Fisher's hand dolorimeter. The examiner places the rubber tip on the examination site and gradually increases the pressure at a rate of approximately 1 kg per second. Subjects are instructed to say ''yes'' when the sensation of pressure causes pain and the pain pressure threshold is recorded. Pain threshold is measured in the 18 points specified by the American College of Rheumatology.
Change in Fibromyalgia Impact Questionnaire (FIQR)
This questionnaire can capture the total spectrum of issues related to FM and the patient's response to therapies. It is one of the most used instrument in trials involving subjects with FM. Also, it has been proven to show consistent response to clinical changes
Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)
This scale is one of the most used instrument to measure quality of life in patients with chronic disease. The QOLS is a 15-item questionnaire that accesses five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. This scale has been shown to be reliable and validated by previous studies

Full Information

First Posted
February 15, 2018
Last Updated
January 3, 2019
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03441997
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
July 17, 2019 (Anticipated)
Study Completion Date
December 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
exercise, low intensity exercise, pain, fatigue, sleep problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full mind-body exercises
Arm Type
Experimental
Arm 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.
Arm Title
Light mobility exercises: Control Group
Arm Type
Active Comparator
Arm 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.
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples.
Intervention Type
Other
Intervention Name(s)
Mind-body exercise
Intervention Description
Exercise program.
Intervention Type
Other
Intervention Name(s)
Light mobility exercises
Intervention Description
Modified mind-body program.
Primary Outcome Measure Information:
Title
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
Description
Changes will be measured during a bout of exhaustive exercise using a recumbent bicycle machine
Time Frame
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 Outcome Measure Information:
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSIQ), which was designed to differentiate between good and poor sleepers. The PSIQ covers subjective sleep quality, sleep latency, sleep disturbances, sleep duration, daytime dysfunction and use of sleep medications. It consists of 19 self-rated questions. The PSIQ has been vastly employed in clinical trials, and it has been reported to be reliable and valid
Time Frame
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Title
Change in Pressure Pain Threshold (PPT)
Description
Pressure pain threshold is defined as the minimum force applied which induces pain. Mechanical pressure, determined as a kilogram (kg) per 1 cm2 of skin on the sensitive areas, is applied by a Fisher's hand dolorimeter. The examiner places the rubber tip on the examination site and gradually increases the pressure at a rate of approximately 1 kg per second. Subjects are instructed to say ''yes'' when the sensation of pressure causes pain and the pain pressure threshold is recorded. Pain threshold is measured in the 18 points specified by the American College of Rheumatology.
Time Frame
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Title
Change in Fibromyalgia Impact Questionnaire (FIQR)
Description
This questionnaire can capture the total spectrum of issues related to FM and the patient's response to therapies. It is one of the most used instrument in trials involving subjects with FM. Also, it has been proven to show consistent response to clinical changes
Time Frame
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Title
Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)
Description
This scale is one of the most used instrument to measure quality of life in patients with chronic disease. The QOLS is a 15-item questionnaire that accesses five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. This scale has been shown to be reliable and validated by previous studies
Time Frame
At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caio Sarmento, PT
Phone
(913) 588-4565
Email
cmessiassarmento@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Taylor Pfeifer
Phone
(913) 588-4565
Email
t009p412@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caio Sarmento
Email
cmessiassarmento@kumc.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
32455108
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.
Results Reference
derived

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

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