FatigueNCT02845492
Evaluating Qigong as a Clinical Intervention for Cancer Survivors' Fatigue
A study testing Qigong and Complete Health Improvement Program (CHIP) in people with Fatigue, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research: 1. Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Fatigue
- What is being tested?
- Qigong and Complete Health Improvement Program (CHIP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Aged 18-70 years
- Self-report of fatigue =/> 3/10 on fatigue interference scale
- Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy)
- no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies is permitted)
- Currently cancer-free
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- Have a primary care or other physician
- Ability to understand English
- Willingness to have blood drawn, have an EEG taken and complete questionnaires
- Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for Qigong practice.
Who cannot join
- History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder)
- Body Mass Index (BMI) > 31
- Active alcohol or drug abuse
- Tobacco use
- Pregnancy
- Regular daily use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs, (does not apply to common use of daily "baby aspirin" as daily prophylactic cardiovascular treatment)
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- Resting systolic blood pressure of less than 90 or greater than 160 and resting diastolic blood pressure of greater than 110.
- Ingestion of caffeine or cocoa products less than two hours from data collection
- Contraindication to regular physical activity participation
- Already engaging in >60 min of vigorous physical activity per week for the prior month
- Weekly practice of yoga, Tai Chi, Qigong, or meditation since the diagnosis of cancer
- Peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miriam Hospital
Providence, Rhode Island, 02904
Chloe Zimmerman, 401-863-6272, cancersurvivor@lifespan.org
About this study
Official title: Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship
This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research:
- Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of Qigong. Using a simple noninvasive EEG setup, the study will test some of the same brain mechanisms that have been found in mindfulness meditation. The study will also investigate Qigong's effects on stress and heart signals and on inflammation in the immune system. A key hypothesis is that Qigong will show distinctive, stronger effects on brain and heart measures. A related hypothesis is that Qigong will show stronger effects on blood markers of inflammation.
- Compare effect sizes of the two interventions in decreasing fatigue in order to plan for a larger clinical trial.
Read the detailed description
Between 20-50% of Cancer Survivors report fatigue following treatment that interferes with their daily life. However, to date no treatment option has been definitively validated as effective for fatigue in survivors. In recent years Mind Body exercises such as yoga, Tai Chi, and Qigong have been shown in small clinical trials to be effective at treating the symptoms of CRF in a wide array of Cancer types. But understanding of basic science mechanisms is poor.
Recent studies of Mindfulness meditation, by the investigators and others, confirm the importance of brain mechanisms related to awareness and attention. This study will assess whether Qigong activates similar physiological processes. The study will also assess (1) whether emotion regulation improves, suggesting that Mindfulness-related processes may partially underlie changes in Qigong as a Mindful exercise (2) whether grip strength improves, suggesting that Qigong activates similar processes to conventional exercise.
As an exploratory question, the study will look at whether brain measures related to awareness are correlated with inflammatory markers called cytokines, suggesting possible neuro-immune interaction that may be relevant for understanding fatigue, vitality and embodied meditative movement therapies such as Qigong, Tai Chi and Yoga.
- Conditions
- Fatigue
- Being tested
- Qigong, Complete Health Improvement Program (CHIP)
- Keywords
- Exercise, Qigong, Mind-Body, Fatigue, Cancer, EEG, HRV
- Medical subject headings
- Fatigue, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongOther
Also called Meditative Exercise Therapy
Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations
Complete Health Improvement Program (CHIP)Other
Also called Wellness-Exercise Program
The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.
| Study group | Role | What they receive |
|---|---|---|
| Qigong intervention | Experimental | Qigong meditative exercise intervention meets three times a week for 10 weeks. The qigong group (n=30) will meet at the Women's Medicine Collaborative, Miriam Hospital (146 W. River St., Providence, RI) for Qigong classes. The lesson will be taught by a validated Qi Gong master with over forty years of experience and the interventional protocol will be validated. Two and a half hours of weekly outside personal practice will also be required of participants. Receives: Other: Qigong |
| CHIP healthy wellness-exercise class | Active comparator | The Complete Health Improvement Program is a validated set of weekly classes designed to promote gentle exercise and wellness related activities in a supportive group setting led by an experienced trainer. Receives: Other: Complete Health Improvement Program (CHIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Symptom Inventory Questionnaire
Questions about daily experience of fatigue
Measured: Change from baseline to 10 weeks
Secondary outcomes (4)
EEG meditative brain measures,
Acquired using a non-invasive EEG cap that sits on the scalp
Measured: at baseline and at 10 weeks
Self-reported Vitality (a component of the Medical Outcomes Short-Form 36)
Measured: at baseline and 10 weeks
Heart Rate Variability (HRV)
Acquired using an EKG
Measured: at baseline and 10 weeks
Inflammatory cytokines
Cytokine measures: Il-1, Il-6, Il-10, tnf-alpha
Measured: at baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Catherine Kerr, The Miriam Hospital
- Investigators
- Catherine Kerr, PhD, Principal investigator, Women's Medicine Collaborative, Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845492
- Sponsor's protocol ID
- MiriamH
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study data will be archived with with computer scripts into a package. These packages will be available to any investigator who requests them.
Publications
Kerr CE, Sacchet MD, Lazar SW, Moore CI, Jones SR. Mindfulness starts with the body: somatosensory attention and top-down modulation of cortical alpha rhythms in mindfulness meditation. Front Hum Neurosci. 2013 Feb 13;7:12. doi: 10.3389/fnhum.2013.00012. eCollection 2013.
PubMed 23408771Schmalzl L, Kerr CE. Editorial: Neural Mechanisms Underlying Movement-Based Embodied Contemplative Practices. Front Hum Neurosci. 2016 Apr 26;10:169. doi: 10.3389/fnhum.2016.00169. eCollection 2016. No abstract available.
PubMed 27199700
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effects of Qigong on a Multi-System Neuro-muscular- Immune Model of Vigor in Cancer Survivorship
- ClinicalTrials.gov ID
- NCT02845492
- Acronym / sponsor ID
- MiriamH
- Conditions
- Fatigue
- Keywords
- Exercise, Qigong, Mind-Body, Fatigue, Cancer, EEG, HRV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Jul 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- 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.
This study compares Qigong movement-based meditation exercise with a healthy living exercise-wellness course. There are two primary goals of this research:
- Evaluate and compare physiological mechanisms underlying the two wellness-exercise interventions with the specific goal of understanding the physiology of Qigong. Using a simple noninvasive EEG setup, the study will test some of the same brain mechanisms that have been found in mindfulness meditation. The study will also investigate Qigong's effects on stress and heart signals and on inflammation in the immune system. A key hypothesis is that Qigong will show distinctive, stronger effects on brain and heart measures. A related hypothesis is that Qigong will show stronger effects on blood markers of inflammation.
- Compare effect sizes of the two interventions in decreasing fatigue in order to plan for a larger clinical trial.
Detailed description
Between 20-50% of Cancer Survivors report fatigue following treatment that interferes with their daily life. However, to date no treatment option has been definitively validated as effective for fatigue in survivors. In recent years Mind Body exercises such as yoga, Tai Chi, and Qigong have been shown in small clinical trials to be effective at treating the symptoms of CRF in a wide array of Cancer types. But understanding of basic science mechanisms is poor.
Recent studies of Mindfulness meditation, by the investigators and others, confirm the importance of brain mechanisms related to awareness and attention. This study will assess whether Qigong activates similar physiological processes. The study will also assess (1) whether emotion regulation improves, suggesting that Mindfulness-related processes may partially underlie changes in Qigong as a Mindful exercise (2) whether grip strength improves, suggesting that Qigong activates similar processes to conventional exercise.
As an exploratory question, the study will look at whether brain measures related to awareness are correlated with inflammatory markers called cytokines, suggesting possible neuro-immune interaction that may be relevant for understanding fatigue, vitality and embodied meditative movement therapies such as Qigong, Tai Chi and Yoga.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong intervention | Experimental | Other: QigongQigong meditative exercise intervention meets three times a week for 10 weeks. The qigong group (n=30) will meet at the Women's Medicine Collaborative, Miriam Hospital (146 W. River St., Providence, RI) for Qigong classes. The lesson will be taught by a validated Qi Gong master with over forty years of experience and the interventional protocol will be validated. Two and a half hours of weekly outside personal practice will also be required of participants. |
| CHIP healthy wellness-exercise class | Active comparator | Other: Complete Health Improvement Program (CHIP)The Complete Health Improvement Program is a validated set of weekly classes designed to promote gentle exercise and wellness related activities in a supportive group setting led by an experienced trainer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients
- Aged 18-70 years
- Self-report of fatigue =/> 3/10 on fatigue interference scale
- Have been diagnosed and completed treatment for cancer (with surgery or radiation or chemotherapy)
- no surgery, radiation or chemotherapy received in the past 8 weeks (ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies is permitted)
Key exclusion criteria (12 listed)
- History or current diagnosis of medical or psychiatric disorder that would interfere with ability to participate in wellness classes or in scientific assessment sessions (e.g., rheumatoid arthritis, diabetes, major psychiatric disorder, connective tissue disorder)
- Body Mass Index (BMI) > 31
- Active alcohol or drug abuse
- Tobacco use
- Pregnancy
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 |
|---|---|---|
| QigongAlso: Meditative Exercise TherapyQigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations | Other | Qigong intervention |
| Complete Health Improvement Program (CHIP)Also: Wellness-Exercise ProgramThe CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing. | Other | CHIP healthy wellness-exercise class |
Primary outcome
Fatigue Symptom Inventory Questionnaire
Time frame: Change from baseline to 10 weeks
Questions about daily experience of fatigue
4 secondary outcomes
EEG meditative brain measures,
Time frame: at baseline and at 10 weeks
Self-reported Vitality (a component of the Medical Outcomes Short-Form 36)
Time frame: at baseline and 10 weeks
Heart Rate Variability (HRV)
Time frame: at baseline and 10 weeks
Inflammatory cytokines
Time frame: at baseline and 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
- Background: PubMed 23408771Kerr CE, Sacchet MD, Lazar SW, Moore CI, Jones SR. Mindfulness starts with the body: somatosensory attention and top-down modulation of cortical alpha rhythms in mindfulness meditation. Front Hum Neurosci. 2013 Feb 13;7:12. doi: 10.3389/fnhum.2013.00012. eCollection 2013.
- Background: PubMed 27199700Schmalzl L, Kerr CE. Editorial: Neural Mechanisms Underlying Movement-Based Embodied Contemplative Practices. Front Hum Neurosci. 2016 Apr 26;10:169. doi: 10.3389/fnhum.2016.00169. eCollection 2016. No abstract available.
- Individual participant dataSharing planned: Yes. Study data will be archived with with computer scripts into a package. These packages will be available to any investigator who requests them.
Related trials for Fatigue
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Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
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Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
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Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
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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.
Catherine Kerr, PhD principal investigator
Women's Medicine Collaborative, Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and Complete Health Improvement Program (CHIP) in people with Fatigue, run by The Miriam Hospital 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 10 inclusion and 12 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 1 Aug 2016. 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 Chloe Zimmerman, BA (4018636272, chloe_zimmerman@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Symptom Inventory Questionnaire (time frame: Change from baseline to 10 weeks). 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 NCT02845492, which also lists 2 linked publications.
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 1 Aug 2016.