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Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss (Breathing)

Primary Purpose

Weight Loss, Metabolism

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep breathing with Yoga positioning
Sponsored by
Touro University Nevada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Weight Loss focused on measuring metabolism, obesity, mentation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Age 18-70 years
  • Body Mass Index at or above 27
  • Stable weight past 3 months
  • able to stand for 10 minutes
  • Able to lift arms overhead

Exclusion Criteria:

  • Chronic Obstructive Pulmonary Disease
  • acute respiratory distress
  • supplemental oxygen use
  • inability to stand, flex trunk, or move arms overhead
  • Pacemaker implant
  • Taking beta blocking medications.

Sites / Locations

  • Michael Laymon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Deep breathing with Yoga positioning

Control

Arm Description

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.

No changes in lifestyle or activities over the 60 day period.

Outcomes

Primary Outcome Measures

Change rom baseline in body Weight
Weight in kilograms
Change from baseline in Body Mass Index
DEXA Measurement of % total fat

Secondary Outcome Measures

Human Growth Hormone - Metabolic rate
Measurement of Human Growth Hormone
VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)
Oxygen consumption via oxygen plethysmograph
Respiratory quotient (RQ) - metabolic rate
CO2 eliminated/O2 consumed
lipid panel - metabolic rate
Total cholesterol, high density lipids, low density lipids, triglycerides

Full Information

First Posted
July 28, 2022
Last Updated
October 20, 2022
Sponsor
Touro University Nevada
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1. Study Identification

Unique Protocol Identification Number
NCT05488574
Brief Title
Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss
Acronym
Breathing
Official Title
Effects of Novel Breathing, Behavior Modification, Yoga Positioning Integrated Program on Weight Loss.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
November 23, 2022 (Anticipated)
Study Completion Date
November 23, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Touro University Nevada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Metabolism
Keywords
metabolism, obesity, mentation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized control group, investigator blinded, repeated measure interventional program.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep breathing with Yoga positioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No changes in lifestyle or activities over the 60 day period.
Intervention Type
Other
Intervention Name(s)
Deep breathing with Yoga positioning
Other Intervention Name(s)
Novel breathing and mindfulness moving-meditation.
Intervention Description
Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner)
Primary Outcome Measure Information:
Title
Change rom baseline in body Weight
Description
Weight in kilograms
Time Frame
Baseline, 10 days, 30 days, and 60 days.
Title
Change from baseline in Body Mass Index
Description
DEXA Measurement of % total fat
Time Frame
Baseline, 10 days, 30 days, and 60 days.
Secondary Outcome Measure Information:
Title
Human Growth Hormone - Metabolic rate
Description
Measurement of Human Growth Hormone
Time Frame
baseline, 10 days, 30 days, 60 days
Title
VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)
Description
Oxygen consumption via oxygen plethysmograph
Time Frame
Baseline, 10 days, 30 days, and 60 days.
Title
Respiratory quotient (RQ) - metabolic rate
Description
CO2 eliminated/O2 consumed
Time Frame
Baseline, 10 days, 30 days, and 60 days.
Title
lipid panel - metabolic rate
Description
Total cholesterol, high density lipids, low density lipids, triglycerides
Time Frame
Baseline, 10 days, 30 days, and 60 days.
Other Pre-specified Outcome Measures:
Title
stress level - autonomic function
Description
Heart Rate Variability
Time Frame
Baseline, 10 days, 30 days, 60 days
Title
Depression
Description
Hamilton Depression Rating Scale (HAM-D) depression index self reported survey scored 0-62 with higher score indicating a worse outcome.
Time Frame
Baseline, 10 days, 30 days, and 60 days.
Title
Sleep
Description
Insomnia Severity Index (ISI) self reported survey scored 0-28 with higher score indicating worse outcome.
Time Frame
Baseline, 10 days, 30 days, and 60 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Age 18-70 years Body Mass Index at or above 27 Stable weight past 3 months able to stand for 10 minutes Able to lift arms overhead Exclusion Criteria: Chronic Obstructive Pulmonary Disease acute respiratory distress supplemental oxygen use inability to stand, flex trunk, or move arms overhead Pacemaker implant Taking beta blocking medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Laymon, DSc, PT
Organizational Affiliation
Touro University Nevada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael Laymon
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
21551954
Citation
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.
Results Reference
result
PubMed Identifier
20834183
Citation
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.
Results Reference
result
PubMed Identifier
20930645
Citation
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.
Results Reference
result
PubMed Identifier
34188389
Citation
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.
Results Reference
result
PubMed Identifier
29188396
Citation
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.
Results Reference
result

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Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss

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