ClinicalTrials.gg
Status unknownNCT03441997Updated Jan 4, 2019

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

An interventional study of Mind-body exercise and Light mobility exercises in Fibromyalgia, sponsored by University of Kansas Medical Center. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 369 studies in Fibromyalgia with a site in United States — 52 open to participants now, 63 under way, 2 of them phase 3. Fibromyalgia · United States.

Planned enrollment
224th of 320
40 · median 72
Started
2018
with 13 others
No phase
167 of 369
34 open now
Registered
240th of 369
by date

Among the 369 studies in Fibromyalgia with a site in United States, this one is the 224th largest by planned enrollment of the 320 interventional ones that give a count, is one of 14 that started in 2018, is one of 167 with no phase, and was the 240th registered.

Fibromyalgia

1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.

Browse Fibromyalgia studies →

Open to participants now

52 of the 369 studies in Fibromyalgia with a site in United States are open now. Recruiting first, the newest first:

47 more — sign in →

All 52 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 160 Fibromyalgia studies recruiting now, 50 (31%) set no upper age limit and 96 (60%) stop at 75 or younger; 14 take children under 18; 35 take healthy volunteers.

This study: 18 Years to 70 Years · female · healthy volunteers too.

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02

Study 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.

03

Conditions studied

  • Fibromyalgia

Keywords

  • exercise
  • low intensity exercise
  • pain
  • fatigue
  • sleep problems
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study 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.

    Other: Mind-body exercise

  • 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

  • No intervention
    Healthy Controls

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

Interventions

  • OtherMind-body exercise

    Exercise program.

  • OtherLight mobility exercises

    Modified mind-body program.

06

What researchers measure

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

    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 outcomes

  1. 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

    Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention

  2. 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.

    Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention

  3. 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

    Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention

  4. 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

    Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention

07

Study locations

1 of 1 sites recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 32455108 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Jul 2019, 17 months after the start.

Of 436 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 17 months is close to that.

Counting every sponsor, half of 449 studies reached it within 15 months; a quarter within 6 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2018
First posted
Feb 22, 2018
StartActual
Feb 1, 2018
Primary completionEst.
Jul 17, 2019
CompletionEst.
Dec 20, 2019
Last update
Jan 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03441997
Responsible party
Sponsor
First posted
Feb 22, 2018
Start date
Feb 1, 2018
Primary completion
Jul 17, 2019 (estimated)
Completion
Dec 20, 2019 (estimated)
Last update
Jan 4, 2019

Study contacts

Caio Sarmento, PT
Contact
cmessiassarmento@kumc.edu
(913) 588-4565
Taylor Pfeifer
Contact
t009p412@kumc.edu
(913) 588-4565
Wen Liu, PhD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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