- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947227
Effects of BBT Versus Diaphragmatic Breathing on Exercise Capacity and Quality of Life in Patients With COPD
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Gulab Devi Hospital, Lahore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: manual chest physical therapy and Buteyko breathing technique
Group A will be treated with manual chest physical therapy and Buteyko breathing technique
|
Group A : will be treated with manual chest physiotherapy & Buteyko Breathing exercise
|
|
Experimental: manual chest physical therapy and Diaphragmatic breathing technique.
Group-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 Minute Walk Distance
Time Frame: 4 weeks.
|
Distance will be measured in meter through 6 minute walk test.
|
4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
St George Respiratory Questionnaire for quality of life :
Time Frame: 4 weeks.
|
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)
|
4 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
oxygen saturation
Time Frame: 4 weeks
|
Oxygen saturation will be measured through pulse oximeter.
|
4 weeks
|
|
heart rate
Time Frame: 4 weeks
|
Pulse rate will be measured through pulse oximeter which will be consider as heart rate of the patient.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sidra Faisal, MS.CPPT, Riphah International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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