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Breathing TechniqueNCT05947227

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

A study testing Buteyko breathing technique and Diaphragmatic breathing technique. in people with Breathing Technique, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Breathing Technique
What is being tested?
Buteyko breathing technique and Diaphragmatic breathing technique.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 sitePakistan
Study dates
15 Jun 2023to 20 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • Cardiologic conditions (<6months ago e.g Myocardial infarction or unstable angina
  • Intubated Patients
  • Orthopedic or urogenital conditions
  • Neurological disorders limiting cognition \& mobility

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Gulab Devi Hospital, Lahore

    Lahore, Punjab Province

Other trials in Pakistan

About this study

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

Read the 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.

Being tested
Buteyko breathing technique, Diaphragmatic breathing technique.
Keywords
Chronic obstructive pulmonary disease/COPD, Diaphragmatic breathing technique
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buteyko breathing techniqueOther

    Group A : will be treated with manual chest physiotherapy \& Buteyko Breathing exercise

  • Diaphragmatic breathing technique.Other

    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

Study groups in NCT05947227
Study groupRoleWhat they receive
manual chest physical therapy and Buteyko breathing techniqueExperimentalGroup A will be treated with manual chest physical therapy and Buteyko breathing technique
Receives: Other: Buteyko breathing technique
manual chest physical therapy and Diaphragmatic breathing technique.ExperimentalGroup-B will be treated with manual chest physical therapy and Diaphragmatic breathing technique.
Receives: Other: Diaphragmatic breathing technique.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minute Walk Distance

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

    Measured: 4 weeks.

Secondary outcomes (1)

  1. 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)

    Measured: 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start15 Jun 2023
  3. Primary completion15 Aug 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05947227
Sponsor's protocol ID
REC/RCR & AHS/23/0311
Status last verified
Jun 2024
First submitted
14 Jun 2023
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32161455

  • 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.

    PubMed 35034709

  • 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.

    PubMed 35279265

  • 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.

    PubMed 23519228

  • 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.

    PubMed 35363800

  • 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.

    PubMed 20113757

  • 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.

    PubMed 28128970

Questions about this trial

What is this clinical trial studying?

A study testing Buteyko breathing technique and Diaphragmatic breathing technique. in people with Breathing Technique, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minute Walk Distance (time frame: 4 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05947227, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.

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