Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brown University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qigong | Other | Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Symptom Inventory Questionnaire | Questions about daily experience of fatigue | Change from baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EEG meditative brain measures, | Acquired using a non-invasive EEG cap that sits on the scalp | at baseline and at 10 weeks |
| Self-reported Vitality (a component of the Medical Outcomes Short-Form 36) |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulties in emotion regulation self-report scale (DERS) | Questions about emotions and emotion regulation | at baseline and 10 weeks |
| Handgrip strength | Uses dynamometer to assess handgrip strength |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chloe Zimmerman, BA | Contact | 4018636272 | chloe_zimmerman@brown.edu | |
| Brendan Cullen, BA | Contact | 4018636272 | Brendan_Cullen@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Catherine Kerr, PhD | Women's Medicine Collaborative, Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miriam Hospital | Recruiting | Providence | Rhode Island | 02904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23408771 | Background | 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. | |
| 27199700 | Background | Schmalzl 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. |
Not provided
Not provided
Study data will be archived with with computer scripts into a package. These packages will be available to any investigator who requests them.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D009043 | Motor Activity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D064906 | Qigong |
| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Complete Health Improvement Program (CHIP) | Other | The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing. |
|
|
| at baseline and 10 weeks |
| Heart Rate Variability (HRV) | Acquired using an EKG | at baseline and 10 weeks |
| Inflammatory cytokines | Cytokine measures: Il-1, Il-6, Il-10, tnf-alpha | at baseline and 10 weeks |
| at baseline and 10 weeks |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |