FibromyalgiaNCT03441997
The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
A study testing Mind-body exercise and Light mobility exercises in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Mind-body exercise and Light mobility exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Show all 11Show fewer
- Severe sleep apnea
- Prostate enlargement or other genitourinary disorder (male patients)
- Pregnancy or breastfeeding
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Caio Sarmento, cmessiassarmento@kumc.edu
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Mind-body exercise, Light mobility exercises
- Keywords
- exercise, low intensity exercise, pain, fatigue, sleep problems
- Medical subject headings
- Fibromyalgia, Motor Activity, Pain, Fatigue, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body exerciseOther
Exercise program.
Light mobility exercisesOther
Modified mind-body program.
| Study group | Role | What they receive |
|---|---|---|
| Full mind-body exercises | Experimental | 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. Receives: Other: Mind-body exercise |
| Light mobility exercises: Control Group | Active comparator | 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. Receives: Other: Light mobility exercises |
| Healthy Controls | No intervention | Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (4)
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
Measured: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
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.
Measured: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
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
Measured: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
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
Measured: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Feb 2018
- Primary completion17 Jul 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441997
- Sponsor's protocol ID
- STUDY00141263
- Status last verified
- Jan 2019
- First submitted
- 15 Feb 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Altered Immune Response to Exercise in Patients With Fibromyalgia Before and After a Mind-body Intervention
- ClinicalTrials.gov ID
- NCT03441997
- Acronym / sponsor ID
- STUDY00141263
- Conditions
- Fibromyalgia
- Keywords
- exercise, low intensity exercise, pain, fatigue, sleep problems
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 17 Jul 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full mind-body exercises | Experimental | Other: Mind-body exerciseParticipants 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. |
| Light mobility exercises: Control Group | Active comparator | Other: Light mobility exercisesThe 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 Controls | No intervention | –Healthy females will be asked to make one visit to complete aerobic exercise test, questionnaires, and provide blood samples. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Female
- No apparent medical condition that will interfere with participation in the study
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body exerciseExercise program. | Other | Full mind-body exercises |
| Light mobility exercisesModified mind-body program. | Other | Light mobility exercises: Control Group |
Primary outcome
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10)
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.
Changes will be measured during a bout of exhaustive exercise using a recumbent bicycle machine
4 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Pressure Pain Threshold (PPT)
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Fibromyalgia Impact Questionnaire (FIQR)
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Change in Quality of Life evaluated by the Quality of Life Scale (QOLS)
Time frame: At two time points: at baseline, and after 8 weeks of qigong/Sham-qigong intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 32455108Sarmento 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Liu, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body exercise and Light mobility exercises in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caio Sarmento, PT ((913) 588-4565, cmessiassarmento@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anti-inflammatory cytokine (IL-6, IL-8, and IL-10) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03441997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.