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

NCT ID: NCT05488574

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-20

Study Completion Date

2022-11-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Weight Loss Metabolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized control group, investigator blinded, repeated measure interventional program.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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Deep breathing with Yoga positioning

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.

Group Type EXPERIMENTAL

Deep breathing with Yoga positioning

Intervention Type OTHER

Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner)

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep breathing with Yoga positioning

Deep breathing with yoga positioning 10min in morning, 1 minute noon, and 1 minute evening (diner)

Intervention Type OTHER

Other Intervention Names

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Novel breathing and mindfulness moving-meditation.

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Touro University Nevada

OTHER

Sponsor Role lead

Responsible Party

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Michael Laymon

Professor, Director Human Performance Laboratory

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S Laymon, DSc, PT

Role: PRINCIPAL_INVESTIGATOR

Touro University Nevada

Locations

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Michael Laymon

Henderson, Nevada, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21551954 (View on PubMed)

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.

Reference Type RESULT
PMID: 20834183 (View on PubMed)

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.

Reference Type RESULT
PMID: 20930645 (View on PubMed)

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.

Reference Type RESULT
PMID: 34188389 (View on PubMed)

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.

Reference Type RESULT
PMID: 29188396 (View on PubMed)

Other Identifiers

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ML-CHHS-22-338

Identifier Type: -

Identifier Source: org_study_id

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