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Comparative Effects of BBT and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in COPD

Primary Purpose

COPD

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Buyteko breathing technique
active cycle of breathing technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Buteyko breathing technique

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of COPD confirmed by smoking history. PFT showing irreversible airflow limitation. Patients hemodynamically stable. Males and females. Patients capable of completing IPAQ questionnaire Exclusion Criteria: Evidence of unstable cardiac disease, Pulmonale decompensation Disabling diseases which prevented participation in the exercise program, such as orthopedic inabilities or peripheral vascular disease. Systemic illness. Resting O2 saturation <90% with room air breathing and Patient with viral infection

Sites / Locations

  • Pulmonary ward Jinnah hospital Lahore.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BUTYEKO BREATHING TECHNIQUE

active cycle of breathing technique

Arm Description

First Group A 20 participants received Buyteko breathing technique while will be given 5 days per week

Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week

Outcomes

Primary Outcome Measures

Borg's dyspnea scale.
For the measurement of dyspnea The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT
Spirometry
Spirometry is the most common of the pulmonary function tests. It measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled. Spirometry is helpful in assessing breathing patterns that identify conditions such as asthma, Chronic obstructive pulmonary disease

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05947253
Brief Title
Comparative Effects of BBT and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in COPD
Official Title
Comparative Effects of BBT and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Comparative effects of Butyeko breathing technique and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease
Detailed Description
A comparative study to determine the effects of butyeko breathing techniques and Active Cycle of Breathing technique on dyspnea and quality of life in patients with chronic obstructive pulmonary disease. As few researches on Butyeko breathing techniques are still present on COPD most of them are on asthma. The goal of the Butyeko Method is to improve breathing patterns, as indicated by achieving a higher breath hold time (control pause). Every five seconds improvement to the control pause, results in an alleviation of breathing difficulty and improved control of COPD The Butyeko method is a purported method of "retraining" the body's breathing pattern to correct for the presumed chronic hyperventilation and hypocapnea, and thereby treat or cure the body of these medical problems. Patients with chronic obstructive pulmonary disease (COPD) often suffer from expectoration. To address this problem, active cycle of breathing techniques (ACBT) can be applied in patients of COPD. In our study daily Butyeko breathing exercise and active cycle of breathing technique session of 30 to 35 minutes will be given to patients and effects of both techniques will be compared. A randomized clinical trial will be conducted using convenient sampling or randomized sampling technique in population of chronic obstructive pulmonary disease (COPD).Total sample size will be of 40 and two Groups will be made Group A 20 participants received Buyteko breathing technique and Groups B 20 participants received Active cycle of breathing technique. Data will be collected by using Borg's dyspnea scale, St.George Respiratory questionnaire and by pulmonary function testing. Data will be collected from pulmonary ward Jinnah hospital Lahore whole study will take total duration of 10 months and data will be analyzed using latest version of SPSS-25 software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Buteyko breathing technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
make 2 groups Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated in two groups by simple randomization process. First Group A 20 participants received Buyteko breathing technique while Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week and data will be collected by using St. George's respiratory questionnaire for determining the quality of life and Borg's dyspnea scale for measuring breathlessness.
Masking
ParticipantInvestigator
Masking Description
Group A 20 participants received Buyteko breathing technique while Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week and data will be collected by using St. George's respiratory questionnaire for determining the quality of life and Borg's dyspnea scale for measuring breathlessness. participant and investigator are blind
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BUTYEKO BREATHING TECHNIQUE
Arm Type
Experimental
Arm Description
First Group A 20 participants received Buyteko breathing technique while will be given 5 days per week
Arm Title
active cycle of breathing technique
Arm Type
Experimental
Arm Description
Group B 20 participants received active cycle of breathing technique and session of 35min will be given 5 days per week
Intervention Type
Other
Intervention Name(s)
Buyteko breathing technique
Intervention Description
group A 20 participants received Buyteko breathing technique 2 session for 3 weeks
Intervention Type
Other
Intervention Name(s)
active cycle of breathing technique
Intervention Description
Group B 20 participants received active cycle of breathing technique 2 session for 3 weeks
Primary Outcome Measure Information:
Title
Borg's dyspnea scale.
Description
For the measurement of dyspnea The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT
Time Frame
4 weeks
Title
Spirometry
Description
Spirometry is the most common of the pulmonary function tests. It measures lung function, specifically the amount and/or speed of air that can be inhaled and exhaled. Spirometry is helpful in assessing breathing patterns that identify conditions such as asthma, Chronic obstructive pulmonary disease
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of COPD confirmed by smoking history. PFT showing irreversible airflow limitation. Patients hemodynamically stable. Males and females. Patients capable of completing IPAQ questionnaire Exclusion Criteria: Evidence of unstable cardiac disease, Pulmonale decompensation Disabling diseases which prevented participation in the exercise program, such as orthopedic inabilities or peripheral vascular disease. Systemic illness. Resting O2 saturation <90% with room air breathing and Patient with viral infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iqbal Tariq, PHD
Phone
O3338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary ward Jinnah hospital Lahore.
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Phone
03022001847
Email
sidra.faisal@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Bilal Baig, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32250871
Citation
Vogelmeier CF, Roman-Rodriguez M, Singh D, Han MK, Rodriguez-Roisin R, Ferguson GT. Goals of COPD treatment: Focus on symptoms and exacerbations. Respir Med. 2020 May;166:105938. doi: 10.1016/j.rmed.2020.105938. Epub 2020 Mar 21.
Results Reference
background
PubMed Identifier
25562549
Citation
May SM, Li JT. Burden of chronic obstructive pulmonary disease: healthcare costs and beyond. Allergy Asthma Proc. 2015 Jan-Feb;36(1):4-10. doi: 10.2500/aap.2015.36.3812.
Results Reference
background
PubMed Identifier
16963544
Citation
Halpin DM, Miravitlles M. Chronic obstructive pulmonary disease: the disease and its burden to society. Proc Am Thorac Soc. 2006 Sep;3(7):619-23. doi: 10.1513/pats.200603-093SS.
Results Reference
background
PubMed Identifier
32664818
Citation
Fazleen A, Wilkinson T. Early COPD: current evidence for diagnosis and management. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620942128. doi: 10.1177/1753466620942128.
Results Reference
background
PubMed Identifier
25210449
Citation
Smith MC, Wrobel JP. Epidemiology and clinical impact of major comorbidities in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2014 Aug 27;9:871-88. doi: 10.2147/COPD.S49621. eCollection 2014.
Results Reference
background
PubMed Identifier
16452599
Citation
Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. doi: 10.1183/09031936.06.00025805. No abstract available.
Results Reference
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Comparative Effects of BBT and Active Cycle of Breathing Technique on Dyspnea and Quality of Life in COPD

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