NCT05488574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

2 months

First QC Date

July 28, 2022

Last Update Submit

October 20, 2022

Conditions

Keywords

metabolismobesitymentation

Outcome Measures

Primary Outcomes (2)

  • 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.

Secondary Outcomes (4)

  • Human Growth Hormone - Metabolic rate

    baseline, 10 days, 30 days, 60 days

  • VO2 at rest, Oxygen consumption at rest-resting metabolic rate(RMR)

    Baseline, 10 days, 30 days, and 60 days.

  • Respiratory quotient (RQ) - metabolic rate

    Baseline, 10 days, 30 days, and 60 days.

  • lipid panel - metabolic rate

    Baseline, 10 days, 30 days, and 60 days.

Other Outcomes (3)

  • stress level - autonomic function

    Baseline, 10 days, 30 days, 60 days

  • Depression

    Baseline, 10 days, 30 days, and 60 days.

  • Sleep

    Baseline, 10 days, 30 days, and 60 days.

Study Arms (2)

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.

Other: Deep breathing with Yoga positioning

Control

NO INTERVENTION

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

Interventions

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

Also known as: Novel breathing and mindfulness moving-meditation.
Deep breathing with Yoga positioning

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael Laymon

Henderson, Nevada, 89014, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Michael S Laymon, DSc, PT

    Touro University Nevada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomized control group, investigator blinded, repeated measure interventional program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director Human Performance Laboratory

Study Record Dates

First Submitted

July 28, 2022

First Posted

August 4, 2022

Study Start

September 20, 2022

Primary Completion

November 23, 2022

Study Completion

November 23, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

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.

Locations