- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07257783
Effect of Buteyko Breathing Exercise Combined With Postural Stability Exercises on Maximal Oxygen Consumption in Young Adult Smokers (BBE PSE VO2max)
Background: Smoking is one of the most significant risk factors for respiratory diseases, affecting both lung function and overall respiratory health. The harmful chemicals in tobacco smoke, contribute to airway inflammation, oxidative stress, and structural lung damage.
Purpose: The purpose of this study was to investigate effect of Buteyko breathing exercise combined with postural stability exercises on maximal oxygen consumption, pulmonary functions, oxygen saturation, functional capacity, and perceived exertion in young adult smokers. Subjects and procedures: Forty male smokers were recruit-ed from Nahda university. Their age ranged between 18-30 years. They were randomly assigned into 2 groups equal in number. Study Group: They participated in 6 weeks training with Buteyko breathing exercise combined with postural stability exercises (3 sessions per week) Control group: They weren't exposed to any intervention. Both groups were assessed by using pulse oximeter to measure oxy-gen saturation, Spirostilk to measure pulmonary functions, Borg scale to measure perceived exertion and six-minute walk test to measure functional capacity and maximal oxygen consumption.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Banī Suwayf, Egypt
- faculty of physical therapy Nahda University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
inclusion criteria
- Cigarette Smokers.
- Smoking period from 3 to 7 years
- They were medically stable.
- Age between 18 to 30 years.
- Male gender only was allowed to participate.
- They had the ability to perform exercises.
- Body mass index ranges from 21 to 25.
exclusion criteria
- Smokers diagnosed with any chronic disease or orthopedic problems.
- Mental disorders.
- Current intervention for cancer or active infection
- Obese their BMI above 26 and athlete people
- People who participated in any activity such as walking for long periods and swimming
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: control group
smokers didn't receive any intervention just measurement at the start of the study and at the end of the study
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Experimental: study group
Buteyko breathing exercise combined with postural stability exercises
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BBE: The therapist instructs the patient to sit comfortably, breathing naturally through the nose.
They should hold their breath until the need to inhale arises, then exhale through the nasal passage.
The patient maintains a straight back with feet shoulder-width apart, eyes closed, breathing calmly.
After 20-30 seconds, they repeat the exercises for 3 minutes, followed by another pause and repetition.
This is done for another 3 minutes, ending with a 2-minute rest before the next session.
Duration: 15 minutes.
PSE :Warming up phase: shoulder circles and twist torso during walking for 5 minutes.
Training phase include 10-15 reps per set, 2-4 sets per exercise,30-60 seconds rest period between sets.
Cooling down phase includes hold each stretch for 15-30 seconds, 2-4 reps per per side and rest for 15-30 seconds between reps.
Bridging Side-lying leg raise Wall push-ups Lateral trunk flexion Chin tuck Stretch pectoralis major muscle,upper trapezius & SCM All these for 3/week for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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maximal oxygen consumption
Time Frame: From enrollment to the end of treatment at 6 weeks
|
it is the highest rate at which the body can take in, transport, and utilize oxygen during intense exercise. It is considered a key indicator of cardiovascular fitness and endurance performance. Measured in: Milliliters of oxygen per kilogram of body weight per minute (ml/kg/min). it was calculated by estimated method from six minute walk test by this equation 12.701 + (0.06 × 6-minute walk distance m) - (0.732 × body mass indexkg/m2) |
From enrollment to the end of treatment at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oxygen saturation
Time Frame: From enrollment to the end of treatment at 6 weeks
|
it refers to the percentage of hemoglobin molecules saturated with oxygen.Pulse oximetry is a simple, non-invasive, widely available medical tool that measures SpO2 through a device attached to a finger, a toe or an ear lobe.
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From enrollment to the end of treatment at 6 weeks
|
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forced viral capacity
Time Frame: From enrollment to the end of treatment at 6 weeks
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Spirometry was used to forced vital capacity (FVC)
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From enrollment to the end of treatment at 6 weeks
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perceived rate of exertion
Time Frame: From enrollment to the end of treatment at 6 weeks
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Measurement of PRE by Modified Borg scale It was used to rate how hard a person feels they are working from 0 to10 0 = No exertion at all & 10 = Maximal exertion
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From enrollment to the end of treatment at 6 weeks
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Functional capacity
Time Frame: From enrollment to the end of treatment at 6 weeks
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It was used to assess the cardiopulmonary fitness of the individuals.
it is measured from 6-MWT
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From enrollment to the end of treatment at 6 weeks
|
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the ratio of forced expiratory volume in 1 Second to forced vital capacity
Time Frame: From enrollment to the end of treatment at 6 week
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Spirometry: was used to assess the ratio of forced expiratory volume in 1 Second (FEV₁) to forced vital capacity (FEV₁ /FVC)
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From enrollment to the end of treatment at 6 week
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forced expiratory volume in 1 Second
Time Frame: From enrollment to the end of treatment at 6 week
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Spirometry was used to assess forced expiratory volume in 1 Second (FEV₁)
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From enrollment to the end of treatment at 6 week
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Maximum voluntary ventilation
Time Frame: From enrollment to the end of treatment at 6 week
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Spirometry was used to assess maximum voluntary ventilation (MVV)
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From enrollment to the end of treatment at 6 week
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- O6U.P.T.REC/024/003002 (Registry Identifier: october 6 university)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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