Lung Tumor ResuctionNCT05118347
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
A study testing Buteyko Breathing Technique in people with Lung Tumor Resuction, run by Shahbaz Ahmad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Lung Tumor Resuction
- What is being tested?
- Buteyko Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2021to 15 Mar 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shahbaz Ahmad
Lahore, Punjab Province, 54000
Shahbaz Ahmad, 03006015668, shahbazahmad4nd@gmail.com
About this study
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.
Read the 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)
- Conditions
- Lung Tumor Resuction
- Being tested
- Buteyko Breathing Technique
- Keywords
- Buteyko Breathing Technique, Incentive Spirometer, Control Pause, Breath Holding Time, Lung Tumor Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buteyko Breathing TechniqueOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko Breathing Technique | Experimental | 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. Receives: Other: Buteyko Breathing Technique |
| Incentive Spirometer | Experimental | 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. Receives: Other: Buteyko Breathing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath Holding Time
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.
Measured: 7 days
Cardiopulmonary Endurance
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.
Measured: 7 days
Quality of Life
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start15 Jul 2021
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Tumor ResuctionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomized into two groups, Buteyko breathing technique group and incentive spirometry group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahbaz Ahmad
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lahore
- Responsible party
- Sponsor-investigator, Shahbaz Ahmad, University of Lahore
- Investigators
- Faiza Sharif, Principal investigator, University of LahoreBilal Umer, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118347
- Sponsor's protocol ID
- SAhmadMSK
- Status last verified
- Nov 2021
- First submitted
- 20 Oct 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05118347
- Acronym / sponsor ID
- SAhmadMSK
- Conditions
- Lung Tumor Resuction
- Keywords
- Buteyko Breathing Technique, Incentive Spirometer, Control Pause, Breath Holding Time, Lung Tumor Resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shahbaz AhmadUniversity, hospital or other
- Collaborators
- University of Lahore
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 12 Nov 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Study participants will be randomized into two groups, Buteyko breathing technique group and incentive spirometry group
| Arm | Type | Receives |
|---|---|---|
| Buteyko Breathing Technique | Experimental | Other: Buteyko Breathing TechniqueButeyko 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. |
| Incentive Spirometer | Experimental | Other: Buteyko Breathing TechniqueAn 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
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 |
|---|---|---|
| Buteyko Breathing TechniqueAlso: Incentive SpirometerAn 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 | Buteyko Breathing Technique, Incentive Spirometer |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: No
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.
Faiza Sharif principal investigator
University of Lahore
Bilal Umer principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko Breathing Technique in people with Lung Tumor Resuction, run by Shahbaz Ahmad at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahbaz Ahmad, MS MSK (03006015668, shahbazahmad4nd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath Holding Time (time frame: 7 days). 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?
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 12 Nov 2021.