ObesityNCT05323500
Effects of Senobi Breathing Exercises in Obese Women
A study testing Senobi breathing exercises in people with Obesity, run by Riphah International University at 2 sites in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Senobi breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Apr 2022to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of age between 30 to 60 years.
- Asian BMI (> 27.5)
- Obese women with mild to moderate depression
Who cannot join
- Sedentary lifestyle
- Following an Unhealthy Diet plan
- Any Cardiopulmonary conditions
- Endocrine conditions: hypothyroidism
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Physical Therapy Private Clinic
Khushāb, Punjab Province
Pakistan sports complex
Lahore, Punjab Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Senobi breathing exercises
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senobi breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Senobi breathing group | Experimental | 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. Receives: Other: Senobi breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung volume
Digital spirometry will be used to assess Lung Volumes and capacities
Measured: changes from Baseline to 3 Months
Body Fat
Body Fat Analyzer will be used to assess percent of body fat
Measured: changes from Baseline to 3 Months
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
Measured: changes from Baseline to 3 Months
Secondary outcomes (1)
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.
Measured: changes from Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start15 Apr 2022
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi experimental Design
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323500
- Sponsor's protocol ID
- REC/01292 Sabahat Ali Sheikh
- Status last verified
- Jul 2022
- First submitted
- 4 Apr 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30056777Mafort 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.
PubMed 27408717Sato 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.
PubMed 20834183Sato 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.
PubMed 21551954Sato 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.
PubMed 20930645
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Senobi Breathing Exercises on Body Fat, Lung Functions and Depression in Obese Women
- ClinicalTrials.gov ID
- NCT05323500
- Acronym / sponsor ID
- REC/01292 Sabahat Ali Sheikh
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi experimental Design
| Arm | Type | Receives |
|---|---|---|
| Senobi breathing group | Experimental | Other: Senobi breathing exercisesThe 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women of age between 30 to 60 years.
- Asian BMI (> 27.5)
- Obese women with mild to moderate depression
Key exclusion criteria (4 listed)
- Sedentary lifestyle
- Following an Unhealthy Diet plan
- Any Cardiopulmonary conditions
- Endocrine conditions: hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senobi breathing exercisesThe 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. | Other | Senobi breathing group |
Primary outcome
Lung volume
Time frame: changes from Baseline to 3 Months
Digital spirometry will be used to assess Lung Volumes and capacities
Body Fat
Time frame: changes from Baseline to 3 Months
Body Fat Analyzer will be used to assess percent of body fat
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
1 secondary outcome
Hamilton Depression rating Scale
Time frame: changes from Baseline to 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Background: PubMed 30056777Dixon 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.
- Background: PubMed 27408717Mafort 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.
- Background: PubMed 20834183Sato 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.
- Background: PubMed 21551954Sato 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.
- Background: PubMed 20930645Sato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PHD* principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senobi breathing exercises in people with Obesity, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung volume (time frame: changes from Baseline to 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05323500, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.