Fatigue Clinical Trial
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:
1. 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.
2. Compare effect sizes of the two interventions in decreasing fatigue in order to plan
for a larger clinical trial.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 - 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. Exclusion Criteria: - 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) - 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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Miriam Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
The Miriam Hospital | Brown University |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Difficulties in emotion regulation self-report scale (DERS) | Questions about emotions and emotion regulation | at baseline and 10 weeks | No |
Other | Handgrip strength | Uses dynamometer to assess handgrip strength | at baseline and 10 weeks | No |
Primary | Fatigue Symptom Inventory Questionnaire | Questions about daily experience of fatigue | Change from baseline to 10 weeks | No |
Secondary | EEG meditative brain measures, | Acquired using a non-invasive EEG cap that sits on the scalp | at baseline and at 10 weeks | No |
Secondary | Self-reported Vitality (a component of the Medical Outcomes Short-Form 36) | at baseline and 10 weeks | No | |
Secondary | Heart Rate Variability (HRV) | Acquired using an EKG | at baseline and 10 weeks | No |
Secondary | Inflammatory cytokines | Cytokine measures: Il-1, Il-6, Il-10, tnf-alpha | at baseline and 10 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04959214 -
The Effect Of Progressıve Relaxatıon Exercıses
|
N/A | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Completed |
NCT04531891 -
Utility and Validity of a High-intensity, Intermittent Exercise Protocol
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Completed |
NCT04960865 -
Kinesio Taping and Calf Muscle Fatigue
|
N/A | |
Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A | |
Active, not recruiting |
NCT05344183 -
Immediate and Short-term Effects of Low-level Laser
|
N/A | |
Completed |
NCT04716049 -
Effectiveness of Recovery Protocols in Elite Professional Young Soccer Players
|
N/A | |
Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05241405 -
Evaluation of the Impact of Taking American Ginseng for 8 Weeks on Fatigue in Patients Treated for Localized Breast Cancer
|
N/A | |
Active, not recruiting |
NCT06074627 -
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
|
N/A | |
Completed |
NCT03943212 -
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
|
N/A | |
Recruiting |
NCT05567653 -
Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers
|
N/A | |
Active, not recruiting |
NCT05636696 -
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
|
N/A | |
Not yet recruiting |
NCT05863897 -
e-COGRAT: A Blended eHealth Intervention for Fatigue Following Acquired Brain Injury
|
N/A | |
Not yet recruiting |
NCT05002894 -
Effect of Pilates Exercises On Fatigue In Post Menopausal Women
|
N/A | |
Recruiting |
NCT04091789 -
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
|
Phase 2 | |
Completed |
NCT02911649 -
Reducing Sedentary Behaviour With Technology
|
N/A | |
Completed |
NCT02321358 -
Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors
|
N/A |