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This study is to evaluate the physical and cognitive effects of a 15 min per day novel breathing and mindfulness moving-meditation program on metabolism, cognition, and emotion health. It is thought that the breathing and movement program will increase basal metabolism, facilitate fat loss, and decrease depressive behaviors. Anthropometric, blood chemistries, and cognitive measures of depression, sleep, and hunger will be measured over a two-month interventional program.
Subjects will be randomized into two groups, an active group and control group. For the first 30 days, the active group will follow the movement/breath program and the controls will be instructed not to change their lifestyle (no change in diet, and no change in exercise / physical activities). The technicians taking measurements will be blinded as to which participants are actives vs controls. The following 30 days' intervention will consist of continuing the Phase I interventions combined with implementing the behavior change strategies on 2 to 3 habit changes self-selected from a list of 30 top "bad habits" that contribute to weight gain and undermine one's ability to lose weight with the control group again not changing any lifestyle activities. Measurements: Measurements will be taken at the start (baseline), 10 days, 30 days, and 60 days of intervention with the measurement days scheduled to evaluate people completing 10 full days of the program, 30 full days, and 60 full days respectively. Measurements taken at each interval to include weight, body composition (lean mass & fat percentages), anthropometric measurements (umbilicus, hips, right thigh, right upper arm), pO2, resting heart rate, HRV, blood pressure, pulmonary health (i.e., O2 max, spirometry), hunger, sleep, and depression rating (by self-assessment survey scale). Serum chemistry for basic metabolic panel, inflammatory markers, and lipids, hematology for oxygen carrying capacity and gross immune response, Human Growth Factor production via ELISA quantification, imaging ultrasound to measure subcutaneous fat thickness at the areas of girth measurements, DEXA for overall and targeted areas body composition, and resting metabolic rate via oxygen plethysmograph.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep breathing with Yoga positioning | Experimental | subjects participating in breathing and moving meditation program. 12 minutes daily of deep breathing and yoga positioning first 30 days, then continuation of breathing and positioning and self-directed, mentored, behavior modification activities the second 30 days. |
|
| Control | No Intervention | No changes in lifestyle or activities over the 60 day period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep breathing with Yoga positioning | Other | Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change rom baseline in body Weight | Weight in kilograms | Baseline, 10 days, 30 days, and 60 days. |
| Change from baseline in Body Mass Index | DEXA Measurement of % total fat | Baseline, 10 days, 30 days, and 60 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Human Growth Hormone - Metabolic rate | Measurement of Human Growth Hormone | baseline, 10 days, 30 days, 60 days |
| VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR) | Oxygen consumption via oxygen plethysmograph |
| Measure | Description | Time Frame |
|---|---|---|
| stress level - autonomic function | Heart Rate Variability | Baseline, 10 days, 30 days, 60 days |
| Depression | Hamilton Depression Rating Scale (HAM-D) depression index self reported survey scored 0-62 with higher score indicating a worse outcome. |
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S Laymon, DSc, PT | Touro University Nevada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Laymon | Henderson | Nevada | 89014 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21551954 | Result | Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise ameliorates depression in obese women through up-regulation of sympathetic nerve activity and hormone secretion. Biomed Res. 2011 Apr;32(2):175-80. doi: 10.2220/biomedres.32.175. | |
| 20834183 | Result | Sato K, Kawamura T, Yamagiwa S. The "Senobi" breathing exercise is recommended as first line treatment for obesity. Biomed Res. 2010 Aug;31(4):259-62. doi: 10.2220/biomedres.31.259. |
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To protect privacy of subjects, Data will be reported as cumulative without individual participant data. In the event of potential health adverse disease process IPD may be shared with individuals' consent to their designated, licensed, healthcare provider.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A randomized control group, investigator blinded, repeated measure interventional program.
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Investigators doing data collection will not know which subjects are interventional and which are controls. Outcomes assessor will not be aware of which group of subjects were interventional and which did not participate in intervention.
|
| Baseline, 10 days, 30 days, and 60 days. |
| Respiratory quotient (RQ) - metabolic rate | CO2 eliminated/O2 consumed | Baseline, 10 days, 30 days, and 60 days. |
| lipid panel - metabolic rate | Total cholesterol, high density lipids, low density lipids, triglycerides | Baseline, 10 days, 30 days, and 60 days. |
| Baseline, 10 days, 30 days, and 60 days. |
| Sleep | Insomnia Severity Index (ISI) self reported survey scored 0-28 with higher score indicating worse outcome. | Baseline, 10 days, 30 days, and 60 days. |
| 20930645 | Result | Sato K, Kawamura T, Abo T. "Senobi" stretch ameliorates asthma symptoms by restoring autonomic nervous system balance. J Investig Med. 2010 Dec;58(8):968-70. doi: 10.231/JIM.0b013e3181f9167b. |
| 34188389 | Result | Nivethitha L, Mooventhan A, Manjunath NK. Evaluation of Cardiovascular Functions during the Practice of Different Types of Yogic Breathing Techniques. Int J Yoga. 2021 May-Aug;14(2):158-162. doi: 10.4103/ijoy.IJOY_61_20. Epub 2021 May 10. |
| 29188396 | Result | Nivethitha L, Mooventhan A, Manjunath NK, Bathala L, Sharma VK. Cerebrovascular Hemodynamics During the Practice of Bhramari Pranayama, Kapalbhati and Bahir-Kumbhaka: An Exploratory Study. Appl Psychophysiol Biofeedback. 2018 Mar;43(1):87-92. doi: 10.1007/s10484-017-9387-8. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |