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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05323500
Other study ID # REC/01292 Sabahat Ali Sheikh
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2022
Est. completion date July 15, 2022

Study information

Verified date July 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 15, 2022
Est. primary completion date July 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Pakistan Physical Therapy Private Clinic Khushab Punjab
Pakistan Pakistan sports complex Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Dixon AE, Peters U. The effect of obesity on lung function. Expert Rev Respir Med. 2018 Sep;12(9):755-767. doi: 10.1080/17476348.2018.1506331. Epub 2018 Aug 14. Review. — View Citation

Mafort TT, Rufino R, Costa CH, Lopes AJ. Obesity: systemic and pulmonary complications, biochemical abnormalities, and impairment of lung function. Multidiscip Respir Med. 2016 Jul 12;11:28. doi: 10.1186/s40248-016-0066-z. eCollection 2016. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lung volume Digital spirometry will be used to assess Lung Volumes and capacities changes from Baseline to 3 Months
Primary Body Fat Body Fat Analyzer will be used to assess percent of body fat changes from Baseline to 3 Months
Primary waist to hip ratio 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 Hamilton Depression rating Scale 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
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