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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Buteyko Breathing Technique
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:
  • Incentive Spirometer
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.
Other: Buteyko Breathing Technique
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:
  • Incentive Spirometer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shahbaz Ahmad

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Lahore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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