- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05118347
Effects of Buteyko Breathing Technique Versus Incentive Spirometer on Breath Holding Time, Cardiopulmonary Endurance and Quality of Life in Patients With Post Lung Tumor Resection
November 1, 2021 updated by: Shahbaz Ahmad
The pulmonary complications are the major cause of morbidity and mortality following Lung surgeries.
The Buteyko breathing technique is used for reversing the health condition such as poor breathing, mouth breathing and over breathing.
Incentive spirometry is widely used postoperatively in the belief that intermittent ventilation restores alveolar aeration and improves oxygenation.
Objective of this study will be to compare the effects of Buteyko breathing technique versus Incentive Spirometer on breath holding time, cardiopulmonary endurance and quality of life in patients with post lung tumor resection.
Sample size was calculated using Control Pause as outcome measure was 16 in each group after adding 20% dropout the sample size will be 16+3=19 in each group.
Participants will be randomized in to two groups Buteyko breathing technique group and incentive spirometry group.
Data will be collected by the Purposive Sampling technique.
Breath Holding time, cardiopulmonary endurance and quality of life will be measured for both groups at the beginning of study (1st post-operative day) and after the end of training (5th post-operative day).
Data will be entered into SPSS for Statistical Analysis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The pulmonary complications are the major cause of morbidity and mortality following Lung surgeries.
The Buteyko breathing technique is used for reversing the health condition such as poor breathing, mouth breathing and over breathing.
Incentive spirometry is widely used postoperatively in the belief that intermittent ventilation restores alveolar aeration and improves oxygenation.
Objective of this study will be to compare the effects of Buteyko breathing technique versus Incentive Spirometer on breath holding time, cardiopulmonary endurance and quality of life in patients with post lung tumor resection.
Sample size was calculated using Control Pause as outcome measure was 16 in each group after adding 20% dropout the sample size will be 16+3=19 in each group.
Participants will be randomized in to two groups Buteyko breathing technique group and incentive spirometry group.
Data will be collected by the Purposive Sampling technique.
Breath Holding time, cardiopulmonary endurance and quality of life will be measured for both groups at the beginning of study (1st post-operative day) and after the end of training (5th post-operative day).
Data will be entered into SPSS for Statistical Analysis.
Study will be completed within 9 months after the approval of synopsis.
Participants included the study will be those who underwent lung surgery for the first time.
Both male and female will be included.
The patient of age between 45-55 years.
Hyperventilated patient due to post-operative pain.
Participants excluded were those having Post-operative renal failure or arrhythmia needed for a pacemaker.
Post-operative mechanical ventilation (more than 24 hours).
Patients suffering from Cardiac diseases.
(Congenital heart disease, Coronary artery disease (narrowing of the arteries), Deep vein thrombosis and pulmonary embolism, Heart attack, Heart failure.
And Heart muscle disease)
Study Type
Interventional
Enrollment (Anticipated)
38
Phase
- 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 Contact
- Name: Shahbaz Ahmad, MS MSK
- Phone Number: 03006015668
- Email: shahbazahmad4nd@gmail.com
Study Contact Backup
- Name: Shahbaz Ahmad
- Phone Number: 03006015668
- Email: shahbazahmad4nd@gmail.com
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Shahbaz Ahmad
-
Contact:
- Shahbaz Ahmad
- Phone Number: 03006015668
- Email: shahbazahmad4nd@gmail.com
-
-
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
Ages Eligible for Study
45 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patients who underwent lung surgery for the first time.
- Both male and female will be included.
- The patient of age between 45-55 years.
- Hyperventilated patient due to post-operative pain
Exclusion Criteria:
- Post-operative renal failure or arrhythmia needed for a pacemaker.
- Post-operative mechanical ventilation (more than 24 hours).
- Patients suffering from Cardiac diseases. (Congenital heart disease, Coronary artery disease (narrowing of the arteries), Deep vein thrombosis and pulmonary embolism, Heart attack, Heart failure. And Heart muscle disease).
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Buteyko Breathing Technique
Buteyko Breathing Method teaches you how to bring your breathing volume back toward normal or, in other words, reverse what's called chronic hyperventilation or chronic over-breathing.
When your breathing is normal (ideally it is shown you should breathe lightly, in a calm fashion, and only through the nose, not mouth), you have better oxygenation of tissues and organs, including your brain.
|
An incentive spirometer is a device that measures how deeply you can inhale (breathe in).
It helps you take slow, deep breaths to expand and fill your lungs with air.
This helps prevent lung problems, such as pneumonia.
The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator.
Other Names:
|
Experimental: Incentive Spirometer
An incentive spirometer is a device that measures how deeply you can inhale (breathe in).
It helps you take slow, deep breaths to expand and fill your lungs with air.
This helps prevent lung problems, such as pneumonia.
The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator.
|
An incentive spirometer is a device that measures how deeply you can inhale (breathe in).
It helps you take slow, deep breaths to expand and fill your lungs with air.
This helps prevent lung problems, such as pneumonia.
The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breath Holding Time
Time Frame: 7 days
|
A test used as a rough index of cardiopulmonary reserve, measured by the length of time a person can hold his or her breath after normal relaxed breathing until the slight feeling of next breath.
Control Pause correlate well with the severity of disease and will be measured in seconds.
Control pause is reliable and valid variable to find out the severity of disease i-e a person who can hold his breath up to 40s.
It will indicate a good pulmonary condition and a person who cannot hold breath up to 10s is in status of poor pulmonary condition.
|
7 days
|
Cardiopulmonary Endurance
Time Frame: 7 days
|
Cardiorespiratory endurance is the level at which your heart, lungs, and muscles work together when you're exercising for an extended period of time. it will be measured by 6 minutes walk test.
Higher the cardiopulmonary endurance indicate a good pulmonary condition.
|
7 days
|
Quality of Life
Time Frame: 7 days
|
World Health Organization defines Quality of Life as an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
it will be measured by WHO Quality of Life Questionnaire at the scale of 0-100.
0 indicates worst quality of life and 100 indicates good quality of life.
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Faiza Sharif, The University of Lahore
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)
July 15, 2021
Primary Completion (Anticipated)
March 15, 2022
Study Completion (Anticipated)
March 15, 2022
Study Registration Dates
First Submitted
October 20, 2021
First Submitted That Met QC Criteria
November 1, 2021
First Posted (Actual)
November 12, 2021
Study Record Updates
Last Update Posted (Actual)
November 12, 2021
Last Update Submitted That Met QC Criteria
November 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAhmadMSK
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.
Clinical Trials on Lung Tumor Resuction
-
National Cancer Institute (NCI)RecruitingLocally Advanced Lung Neuroendocrine Neoplasm | Lung Neuroendocrine Neoplasm | Metastatic Lung Neuroendocrine Neoplasm | Recurrent Lung Neuroendocrine Neoplasm | Unresectable Lung Neuroendocrine Neoplasm | Advanced Lung Neuroendocrine Tumor | Functioning Lung Neuroendocrine Tumor | Lung Neuroendocrine... and other conditionsUnited States
-
DeuterOncologyRecruitingAdult Solid Tumor | Lung Cancer | Advanced Solid Tumor | Non-small Cell Lung Cancer | Non-small Cell Carcinoma | Refractory Tumor | Hereditary Renal Papillary CancerFrance, Belgium, Netherlands
-
Navire Pharma Inc., a BridgeBio companyAmgenRecruitingNon Small Cell Lung Cancer | Metastatic Solid Tumor | Solid Tumor, Adult | Metastatic NSCLCSpain, Australia, France, Denmark, Greece, Italy, Netherlands
-
Guangzhou Institute of Respiratory DiseaseRecruitingPoor Performance Status | Malignant Tumor of LungChina
-
University of Roma La SapienzaRecruitingLung Cancer | Circulating Tumor Cell | Spreading of TumorItaly
-
Ohio State University Comprehensive Cancer CenterActive, not recruitingLung Cancer | Radiation Toxicity | Adult Brain TumorUnited States
-
Roswell Park Cancer InstituteNeuroEndocrine Tumor Research Foundation (NETRF)RecruitingLung Atypical Carcinoid Tumor | Metastatic Pancreatic Neuroendocrine Tumor | Lung Typical Carcinoid TumorUnited States
-
Peking University Cancer Hospital & InstituteActive, not recruiting
-
Centre Hospitalier Universitaire de BesanconCompletedRenal Tumor | Bone Tumor | Lung TumorFrance
-
National Cancer Institute (NCI)Active, not recruitingCarcinoid Tumor | Functioning Pancreatic Neuroendocrine Tumor | Intermediate Grade Lung Neuroendocrine Neoplasm | Locally Advanced Pancreatic Neuroendocrine Tumor | Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm | Low Grade Lung Neuroendocrine Neoplasm | Metastatic Digestive... and other conditionsUnited States
Clinical Trials on Buteyko Breathing Technique
-
Riphah International UniversityRecruitingBreathing TechniquePakistan
-
Mansoura UniversityCompleted
-
ARCIM Institute Academic Research in Complementary...University Hospital TuebingenCompleted
-
Riphah International UniversityCompletedPost-Cardiac Surgery PatientsPakistan
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityCompleted
-
ARCIM Institute Academic Research in Complementary...Completed
-
Basma Mosaad Abd-elrahman AbushadyCompleted
-
Riphah International UniversityRecruiting