search
Back to results

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

Primary Purpose

Lung Tumor Resuction

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Buteyko Breathing Technique
Sponsored by
Shahbaz Ahmad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Tumor Resuction focused on measuring Buteyko Breathing Technique, Incentive Spirometer, Control Pause, Breath Holding Time, Lung Tumor Resection

Eligibility Criteria

45 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Shahbaz AhmadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Buteyko Breathing Technique

Incentive Spirometer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2021
Last Updated
November 1, 2021
Sponsor
Shahbaz Ahmad
Collaborators
University of Lahore
search

1. Study Identification

Unique Protocol Identification Number
NCT05118347
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shahbaz Ahmad
Collaborators
University of Lahore

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Tumor Resuction
Keywords
Buteyko Breathing Technique, Incentive Spirometer, Control Pause, Breath Holding Time, Lung Tumor Resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomized into two groups, Buteyko breathing technique group and incentive spirometry group
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Buteyko Breathing Technique
Arm Type
Experimental
Arm Description
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.
Arm Title
Incentive Spirometer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Buteyko Breathing Technique
Other Intervention Name(s)
Incentive Spirometer
Intervention Description
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.
Primary Outcome Measure Information:
Title
Breath Holding Time
Description
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.
Time Frame
7 days
Title
Cardiopulmonary Endurance
Description
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.
Time Frame
7 days
Title
Quality of Life
Description
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.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahbaz Ahmad, MS MSK
Phone
03006015668
Email
shahbazahmad4nd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shahbaz Ahmad
Phone
03006015668
Email
shahbazahmad4nd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faiza Sharif
Organizational Affiliation
The University of Lahore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bilal Umer
Organizational Affiliation
The University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahbaz Ahmad
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahbaz Ahmad
Phone
03006015668
Email
shahbazahmad4nd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs