NCT05118347

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

October 20, 2021

Last Update Submit

November 1, 2021

Conditions

Keywords

Buteyko Breathing TechniqueIncentive SpirometerControl PauseBreath Holding TimeLung Tumor Resection

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    7 days

Study Arms (2)

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.

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.

Other: Buteyko Breathing Technique

Interventions

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.

Also known as: Incentive Spirometer
Buteyko Breathing TechniqueIncentive Spirometer

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahbaz Ahmad

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

  • Faiza Sharif

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Bilal Umer

    University of Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahbaz Ahmad, MS MSK

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study participants will be randomized into two groups, Buteyko breathing technique group and incentive spirometry group
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shahbaz Ahmad

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 12, 2021

Study Start

July 15, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations