Effects of Senobi Breathing Exercises in Obese Women

July 27, 2022 updated by: Riphah International University

Effects of Senobi Breathing Exercises on Body Fat, Lung Functions and Depression in Obese Women

Previous studies have been done just in studying the relationship between breathing technique and obesity and described how it proved helpful in decreasing body fat. This study will be very helpful for future researchers as well as in filling the literature gap by explaining the importance of SBE (Senobi Breathing Exercise) in correlation with increased body fat, compromised lung function and depression in females of age from 30 to 60 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is quasi-experimental study, which is being conducted in a private clinical settings in Khushab. Sample size of 20 individuals was calculated using Hamilton Depression Scale with effect size 0.97 G Power 3.1.9.2 software. The study participants will be screened first, then trained to perform SBE(1-minute maneuver). Participants will be instructed to stand upright and tighten their gluteal muscle and then ask them to put one foot in front of their body and placing most of their body weight on back foot. Then, ask them to breath in for three seconds simultaneously, by raising their hands in the air above their heads. After this, instruct them to exhale by using their whole body for pushing air out of the lungs. Participants will also guided to tighten all their body muscles while pushing air out. Exhale should last for seven seconds. The participants will also guided to repeat this procedure 3 times in one minute with resting period of 10 seconds. They will perform it 3 times a day for 3 months. Assessments will be taken at Baseline & after 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Khushab, Punjab, Pakistan
        • Physical Therapy Private Clinic
      • Lahore, Punjab, Pakistan
        • Pakistan sports complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women of age between 30 to 60 years.
  • Asian BMI (> 27.5)
  • Obese women with mild to moderate depression

Exclusion Criteria:

  • Sedentary lifestyle
  • Following an Unhealthy Diet plan
  • Any Cardiopulmonary conditions
  • Endocrine conditions: hypothyroidism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Senobi breathing group
The study participants will be screened first, then trained to perform SBE (1-minute maneuver). The participants will also guided to repeat this procedure 3 times in one minute with resting period of 10 seconds. They will perform it 3 times a day for 3 months. Assessments will be taken at Baseline & after 3 months.
Other: Senobi breathing exercises
The study participants will be screened first, then trained to perform SBE (1-minute maneuver). Participants will be instructed to stand upright and tighten their gluteal muscle and then ask them to put one foot in front of their body and placing most of their body weight on back foot. Then, ask them to breath in for three seconds simultaneously, by raising their hands in the air above their heads. After this, instruct them to exhale by using their whole body for pushing air out of the lungs. Participants will also guided to tighten all their body muscles while pushing air out. Exhale should last for seven seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lung volume
Time Frame: changes from Baseline to 3 Months
Digital spirometry will be used to assess Lung Volumes and capacities
changes from Baseline to 3 Months
Body Fat
Time Frame: changes from Baseline to 3 Months
Body Fat Analyzer will be used to assess percent of body fat
changes from Baseline to 3 Months
waist to hip ratio
Time Frame: changes from Baseline to 3 Months
Participant is asked to Stand up straight and breathe out. tape measure will be used to check the distance around the smallest part of your waist, just above your belly button. This is waist circumference. Then we will measure the distance around the largest part of your hips - the widest part of your buttocks. This is hip circumference.Waist Hip ratio will be calculated by dividing waist circumference to hip circumference
changes from Baseline to 3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hamilton Depression rating Scale
Time Frame: changes from Baseline to 3 Months
Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression, the maximum score being 52 on the 17-point scale.
changes from Baseline to 3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/01292 Sabahat Ali Sheikh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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