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Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD

Primary Purpose

Breathing Technique

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Buteyko breathing technique
Diaphragmatic breathing technique.
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breathing Technique focused on measuring Chronic obstructive pulmonary disease/COPD, Diaphragmatic breathing technique

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age group : 40-65 years Both males and females Clinical diagnosis of COPD confirmed by smoking history and PFT airflow Patients taking their regular medications e.g bronchodilator Exclusion Criteria: Restrictive lung disease Pneumothorax Resting O2 saturation <90% with room air breathing Recent exacerbations Patients with active viral or bacterial infection Abdominal or thoracic surgery (<3months ago) Cardiologic conditions (<6months ago e.g Myocardial infarction or unstable angina Intubated Patients Orthopedic or urogenital conditions Neurological disorders limiting cognition & mobility

Sites / Locations

  • Gulab Devi Hospital, LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

manual chest physical therapy and Buteyko breathing technique

manual chest physical therapy and Diaphragmatic breathing technique.

Arm Description

Group A will be treated with manual chest physical therapy and Buteyko breathing technique

Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique.

Outcomes

Primary Outcome Measures

6 Minute Walk Distance
Distance will be measured in meter through 6 minute walk test.

Secondary Outcome Measures

St George Respiratory Questionnaire for quality of life :
St George Respiratory Questionnaire/SGRQ is a well established disease specific for health status in asthma and COPD (26).A total three component scores are provided , symptoms (8 items) , activity (16 items) and impacts (26 items), 50 items vary as likert type scale and dichotomus (true/false). In the symptom component , patients are instructed to recall their symptoms in a specific time frame of 1 month , 3 months or 1 year. Other items are not time specific.Scores ranged from 0 ( no impairment ) to 100 ( worst health status)

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
NCT05947227
Brief Title
Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD
Official Title
Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With 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 15, 2023 (Anticipated)
Study Completion Date
November 20, 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
Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks
Detailed Description
A randomized clinical trial will be conducted at Gulab Devi Hospital, Lahore through convenience sampling technique on 48 patients which will be allocated through simple random sampling through sealed enveloped into group A and group B. Pre-treatment values of patients exercise capacity will be recorded by 6MWT/6MWD- 6 minute walk test/ 6 minutes' walk distance and patients quality of life through St George respiratory questionnaire as primary outcomes while oxygen saturation, heart rate will be measured by pulse oximtery during 6MWT as secondary outcomes. Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks. Data will be analyzed using SPSS software version 25.After assessing normality of data by Shapiro-Wilk test , it will be decidedeither parametric or non-parametric test will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Technique
Keywords
Chronic obstructive pulmonary disease/COPD, Diaphragmatic breathing technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A will be treated with manual chest physical therapy and Buteyko breathing technique Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique. Patients will perform the technique 5 times a weeks for 8weeks and treatment evaluation will be done after 8 weeks.
Masking
Participant
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
manual chest physical therapy and Buteyko breathing technique
Arm Type
Experimental
Arm Description
Group A will be treated with manual chest physical therapy and Buteyko breathing technique
Arm Title
manual chest physical therapy and Diaphragmatic breathing technique.
Arm Type
Experimental
Arm Description
Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique.
Intervention Type
Other
Intervention Name(s)
Buteyko breathing technique
Intervention Description
Group A : will be treated with manual chest physiotherapy & Buteyko Breathing exercise
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing technique.
Intervention Description
Group B : will be treated with manual chest physiotherapy & Diaphragmatic Breathing Treatment evaluation will be done after 8 weeks through 6MWT & St George respiratory Questionnaire. Patients will perform technique 5 times a weeks for 8 weeks
Primary Outcome Measure Information:
Title
6 Minute Walk Distance
Description
Distance will be measured in meter through 6 minute walk test.
Time Frame
4 weeks.
Secondary Outcome Measure Information:
Title
St George Respiratory Questionnaire for quality of life :
Description
St George Respiratory Questionnaire/SGRQ is a well established disease specific for health status in asthma and COPD (26).A total three component scores are provided , symptoms (8 items) , activity (16 items) and impacts (26 items), 50 items vary as likert type scale and dichotomus (true/false). In the symptom component , patients are instructed to recall their symptoms in a specific time frame of 1 month , 3 months or 1 year. Other items are not time specific.Scores ranged from 0 ( no impairment ) to 100 ( worst health status)
Time Frame
4 weeks.
Other Pre-specified Outcome Measures:
Title
oxygen saturation
Description
Oxygen saturation will be measured through pulse oximeter.
Time Frame
4 weeks
Title
heart rate
Description
Pulse rate will be measured through pulse oximeter which will be consider as heart rate of the patient.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age group : 40-65 years Both males and females Clinical diagnosis of COPD confirmed by smoking history and PFT airflow Patients taking their regular medications e.g bronchodilator Exclusion Criteria: Restrictive lung disease Pneumothorax Resting O2 saturation <90% with room air breathing Recent exacerbations Patients with active viral or bacterial infection Abdominal or thoracic surgery (<3months ago) Cardiologic conditions (<6months ago e.g Myocardial infarction or unstable angina Intubated Patients Orthopedic or urogenital conditions Neurological disorders limiting cognition & mobility
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
Gulab Devi Hospital, Lahore
City
Lahore
State/Province
Punjab
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
Mamoona Anwar, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32161455
Citation
Iheanacho I, Zhang S, King D, Rizzo M, Ismaila AS. Economic Burden of Chronic Obstructive Pulmonary Disease (COPD): A Systematic Literature Review. Int J Chron Obstruct Pulmon Dis. 2020 Feb 26;15:439-460. doi: 10.2147/COPD.S234942. eCollection 2020.
Results Reference
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PubMed Identifier
35034709
Citation
Chatreewatanakul B, Othaganont P, Hickman RL. Early symptom recognition and symptom management among exacerbation COPD patients: A qualitative study. Appl Nurs Res. 2022 Feb;63:151522. doi: 10.1016/j.apnr.2021.151522. Epub 2021 Nov 6.
Results Reference
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PubMed Identifier
35279265
Citation
Adeloye D, Song P, Zhu Y, Campbell H, Sheikh A, Rudan I; NIHR RESPIRE Global Respiratory Health Unit. Global, regional, and national prevalence of, and risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a systematic review and modelling analysis. Lancet Respir Med. 2022 May;10(5):447-458. doi: 10.1016/S2213-2600(21)00511-7. Epub 2022 Mar 10.
Results Reference
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PubMed Identifier
23519228
Citation
Gea J, Agusti A, Roca J. Pathophysiology of muscle dysfunction in COPD. J Appl Physiol (1985). 2013 May;114(9):1222-34. doi: 10.1152/japplphysiol.00981.2012. Epub 2013 Mar 21.
Results Reference
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PubMed Identifier
35363800
Citation
Cavalcanti JD, Fregonezi GAF, Sarmento AJ, Bezerra T, Gualdi LP, Pennati F, Aliverti A, Resqueti VR. Electrical activity and fatigue of respiratory and locomotor muscles in obstructive respiratory diseases during field walking test. PLoS One. 2022 Apr 1;17(4):e0266365. doi: 10.1371/journal.pone.0266365. eCollection 2022.
Results Reference
background
PubMed Identifier
20113757
Citation
Tang CY, Taylor NF, Blackstock FC. Chest physiotherapy for patients admitted to hospital with an acute exacerbation of chronic obstructive pulmonary disease (COPD): a systematic review. Physiotherapy. 2010 Mar;96(1):1-13. doi: 10.1016/j.physio.2009.06.008. Epub 2009 Sep 22.
Results Reference
background
PubMed Identifier
28128970
Citation
Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.
Results Reference
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Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD

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