NCT05587829

Brief Summary

It will be a randomized control trial at Services Hospital Lahore through convenience sampling technique which will be allocated through simple random sampling through sealed opaque enveloped in to Group A and Group B . Group A: patients will be treated with basic breathing technique whereas Group B: will be treated by will be breathing technique along with diaphragm and abdominal training. The study will be completed within 6 months after synopsis approval from ethical Committee of RCRS \& AHS . Data will be entered and analyzed by SPSS version 25. After assessing the normality of data , it will be decided either parametric or non-parametric test will be use within a group or between two groups.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

September 5, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

dyspneapulmonary function testingdiaphragmatic trainingabdominal training

Outcome Measures

Primary Outcomes (2)

  • • Spirometer for pulmonary function testing FVC

    The most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible intoThe most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible into a tube connected to the spirometer, a small machine. a tube connected to the spirometer, a small machine.

    4 months

  • • Spirometer for pulmonary function testing FVC1

    The most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible intoThe most effective and common method for diagnosing COPD is spirometry. Its also known as a pulmonary function test or PFT. This easy, painless test measures lung function and capacity. To perform this test, you will exhale as forcefully as possible into a tube connected to the spirometer, a small machine. a tube connected to the spirometer, a small machine.

    4 months

Secondary Outcomes (1)

  • • Dyspnea MDP

    4 months

Study Arms (2)

Group A

EXPERIMENTAL

Group A: will be treated with basic breathing technique.

Other: basic breathing technique

Group B

EXPERIMENTAL

Group B: will be treated by will be breathing technique along with diaphragm and abdominal training.

Other: • Diaphragmatic breathing techniqueOther: basic breathing technique

Interventions

In supine position, the participant inhales through the mouth for 5 s to expand the abdomen to the maximal level, minimizing movement of the thorax, and performs a long exhalation to maintain a lower abdominal contraction and retroversion of the pelvis

Also known as: • Abdominal breathing technique
Group B

Deep Breathing for 15 minutes

Group AGroup B

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age group of 35-60 years
  • Moderate COPD patients.
  • Cognitive
  • no previous surgery
  • clinically stable COPD patients with reduced inspiratory muscle strength \[Pi and persistent activity-related dyspnea

You may not qualify if:

  • Acute attack
  • Severe copd
  • Inability to perform physiological testing
  • active cardiovascular comorbidity (i.e., severe heart failure with reduced left ventricular ejection fraction, cardiomyopathy, recent acute myocardial infarction, cardiac arrhythmias, or stroke),
  • Unstable
  • Red Flags Like: Fever, Night Sweats, Malaise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Olloquequi J. COVID-19 Susceptibility in chronic obstructive pulmonary disease. Eur J Clin Invest. 2020 Oct;50(10):e13382. doi: 10.1111/eci.13382. Epub 2020 Sep 2.

    PMID: 32780415BACKGROUND
  • Magitta NF, Walker RW, Apte KK, Shimwela MD, Mwaiselage JD, Sanga AA, Namdeo AK, Madas SJ, Salvi SS. Prevalence, risk factors and clinical correlates of COPD in a rural setting in Tanzania. Eur Respir J. 2018 Jan 31;51(2):1700182. doi: 10.1183/13993003.00182-2017. Print 2018 Feb.

    PMID: 29386343BACKGROUND
  • Langer D, Ciavaglia C, Faisal A, Webb KA, Neder JA, Gosselink R, Dacha S, Topalovic M, Ivanova A, O'Donnell DE. Inspiratory muscle training reduces diaphragm activation and dyspnea during exercise in COPD. J Appl Physiol (1985). 2018 Aug 1;125(2):381-392. doi: 10.1152/japplphysiol.01078.2017. Epub 2018 Mar 15.

    PMID: 29543134BACKGROUND
  • Waatevik M, Johannessen A, Hardie JA, Bjordal JM, Aukrust P, Bakke PS, Eagan TM. Different COPD disease characteristics are related to different outcomes in the 6-minute walk test. COPD. 2012 Jun;9(3):227-34. doi: 10.3109/15412555.2011.650240. Epub 2012 Apr 12.

    PMID: 22497532BACKGROUND
  • Masjedi M, Ainy E, Zayeri F, Paydar R. Assessing the Prevalence and Incidence of Asthma and Chronic Obstructive Pulmonary Disease in the Eastern Mediterranean Region. Turk Thorac J. 2018 Apr;19(2):56-60. doi: 10.5152/TurkThoracJ.2018.17051. Epub 2018 Apr 1.

    PMID: 29755807BACKGROUND
  • Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30.

    PMID: 27028990BACKGROUND
  • Yamaguti WP, Claudino RC, Neto AP, Chammas MC, Gomes AC, Salge JM, Moriya HT, Cukier A, Carvalho CR. Diaphragmatic breathing training program improves abdominal motion during natural breathing in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Apr;93(4):571-7. doi: 10.1016/j.apmr.2011.11.026.

    PMID: 22464088BACKGROUND
  • Xu W, Li R, Guan L, Wang K, Hu Y, Xu L, Zhou L, Chen R, Chen X. Combination of inspiratory and expiratory muscle training in same respiratory cycle versus different cycles in COPD patients: a randomized trial. Respir Res. 2018 Nov 20;19(1):225. doi: 10.1186/s12931-018-0917-6.

    PMID: 30458805BACKGROUND
  • Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.

    PMID: 21282809BACKGROUND
  • Lu Y, Li P, Li N, Wang Z, Li J, Liu X, Wu W. Effects of Home-Based Breathing Exercises in Subjects With COPD. Respir Care. 2020 Mar;65(3):377-387. doi: 10.4187/respcare.07121. Epub 2019 Nov 12.

    PMID: 31719191BACKGROUND
  • Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026.

    PMID: 11069801BACKGROUND
  • Bostanci O, Mayda H, Yilmaz C, Kabadayi M, Yilmaz AK, Ozdal M. Inspiratory muscle training improves pulmonary functions and respiratory muscle strength in healthy male smokers. Respir Physiol Neurobiol. 2019 Jun;264:28-32. doi: 10.1016/j.resp.2019.04.001. Epub 2019 Apr 3.

    PMID: 30953791BACKGROUND
  • Wang J, Guo S, Zeng M, Yu P, Mo W. Observation of the curative effect of device-guided rehabilitation on respiratory function in stable patients with chronic obstructive pulmonary disease. Medicine (Baltimore). 2019 Feb;98(8):e14034. doi: 10.1097/MD.0000000000014034.

    PMID: 30813125BACKGROUND
  • Kim NS, Seo JH, Ko MH, Park SH, Kang SW, Won YH. Respiratory Muscle Strength in Patients With Chronic Obstructive Pulmonary Disease. Ann Rehabil Med. 2017 Aug;41(4):659-666. doi: 10.5535/arm.2017.41.4.659. Epub 2017 Aug 31.

    PMID: 28971051BACKGROUND
  • O'Donnell DE, Milne KM, James MD, de Torres JP, Neder JA. Dyspnea in COPD: New Mechanistic Insights and Management Implications. Adv Ther. 2020 Jan;37(1):41-60. doi: 10.1007/s12325-019-01128-9. Epub 2019 Oct 30.

    PMID: 31673990BACKGROUND
  • Abdallah SJ, Smith BM, Wilkinson-Maitland C, Li PZ, Bourbeau J, Jensen D. Effect of Abdominal Binding on Diaphragmatic Neuromuscular Efficiency, Exertional Breathlessness, and Exercise Endurance in Chronic Obstructive Pulmonary Disease. Front Physiol. 2018 Nov 14;9:1618. doi: 10.3389/fphys.2018.01618. eCollection 2018.

    PMID: 30487757BACKGROUND
  • Leelarungrayub J, Puntumetakul R, Sriboonreung T, Pothasak Y, Klaphajone J. Preliminary study: comparative effects of lung volume therapy between slow and fast deep-breathing techniques on pulmonary function, respiratory muscle strength, oxidative stress, cytokines, 6-minute walking distance, and quality of life in persons with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 5;13:3909-3921. doi: 10.2147/COPD.S181428. eCollection 2018.

    PMID: 30584292BACKGROUND
  • Wada JT, Borges-Santos E, Porras DC, Paisani DM, Cukier A, Lunardi AC, Carvalho CR. Effects of aerobic training combined with respiratory muscle stretching on the functional exercise capacity and thoracoabdominal kinematics in patients with COPD: a randomized and controlled trial. Int J Chron Obstruct Pulmon Dis. 2016 Oct 28;11:2691-2700. doi: 10.2147/COPD.S114548. eCollection 2016.

    PMID: 27822031BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Wajeeha Zia, PP-DPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wajeeha Zia, PP-DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

October 20, 2022

Study Start

October 1, 2022

Primary Completion

December 30, 2022

Study Completion

January 1, 2023

Last Updated

October 20, 2022

Record last verified: 2022-10