Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
• Diaphragmatic breathing technique
basic breathing technique
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring dyspnea, pulmonary function testing, diaphragmatic training, abdominal training
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Group A: will be treated with basic breathing technique.
Group B: will be treated by will be breathing technique along with diaphragm and abdominal training.
Outcomes
Primary Outcome Measures
• 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.
• 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.
Secondary Outcome Measures
• Dyspnea MDP
Use these scales to rate the intensity of the breathing sensations you feel [felt] (like the loudness of sound, regardless of whether the sensation is pleasant or unpleasant; for example a sensation could be intense without being unpleasant.)
Full Information
NCT ID
NCT05587829
First Posted
September 5, 2022
Last Updated
October 17, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05587829
Brief Title
Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.
Official Title
Effects of Diaphragm and Abdominal Muscle Training on Pulmonary Function Testing and Dyspnea Among Chronic Obstructive Pulmonary Disease Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 1, 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
No
5. Study Description
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.
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a set of diseases that cause airflow obstruction, breathing difficulties, wheezing and chest tightness. Risk factors are smoking and non-tobacco-smoking, the use of biomass fuel and open fires for domestic purposes in poorly ventilated households. Physiotherapy is an important component of multidisciplinary therapies. Airway clearing, pulmonary rehabilitation, inspiratory muscle training, and non-invasive ventilation is the prior treatment .The aim of this study will be to find the effects of diaphragm and abdominal muscle training on pulmonary function testing and dyspnea among COPD patients .
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
dyspnea, pulmonary function testing, diaphragmatic training, abdominal training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Group A: will be treated with basic breathing technique.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B: will be treated by will be breathing technique along with diaphragm and abdominal training.
Intervention Type
Other
Intervention Name(s)
• Diaphragmatic breathing technique
Other Intervention Name(s)
• Abdominal breathing technique
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
basic breathing technique
Intervention Description
Deep Breathing for 15 minutes
Primary Outcome Measure Information:
Title
• Spirometer for pulmonary function testing FVC
Description
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.
Time Frame
4 months
Title
• Spirometer for pulmonary function testing FVC1
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
• Dyspnea MDP
Description
Use these scales to rate the intensity of the breathing sensations you feel [felt] (like the loudness of sound, regardless of whether the sensation is pleasant or unpleasant; for example a sensation could be intense without being unpleasant.)
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wajeeha Zia, PP-DPT
Phone
0323 4500788
Email
wajeeha.zia@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajeeha Zia, PP-DPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
32780415
Citation
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.
Results Reference
background
PubMed Identifier
29386343
Citation
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.
Results Reference
background
PubMed Identifier
29543134
Citation
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.
Results Reference
background
PubMed Identifier
22497532
Citation
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.
Results Reference
background
PubMed Identifier
29755807
Citation
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. Erratum In: Turk Thorac J. 2018 Jul;19(3):158.
Results Reference
background
PubMed Identifier
27028990
Citation
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.
Results Reference
background
PubMed Identifier
22464088
Citation
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.
Results Reference
background
PubMed Identifier
30458805
Citation
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.
Results Reference
background
PubMed Identifier
21282809
Citation
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.
Results Reference
background
PubMed Identifier
31719191
Citation
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.
Results Reference
background
PubMed Identifier
11069801
Citation
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.
Results Reference
background
PubMed Identifier
30953791
Citation
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.
Results Reference
background
PubMed Identifier
30813125
Citation
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.
Results Reference
background
PubMed Identifier
28971051
Citation
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.
Results Reference
background
PubMed Identifier
31673990
Citation
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.
Results Reference
background
PubMed Identifier
30487757
Citation
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.
Results Reference
background
PubMed Identifier
30584292
Citation
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.
Results Reference
background
PubMed Identifier
27822031
Citation
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.
Results Reference
background
Learn more about this trial
Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.
We'll reach out to this number within 24 hrs