Chronic Obstructive Pulmonary DiseaseNCT05587829
Effects of Diaphragm and Abdominal Muscle Training on PFT and Dyspnea Among COPD Obstructive Pulmonary Disease Patients.
A study testing • Diaphragmatic breathing technique and basic breathing technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- • Diaphragmatic breathing technique and basic breathing technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to 1 Jan 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Diaphragm and Abdominal Muscle Training on Pulmonary Function Testing and Dyspnea Among Chronic Obstructive Pulmonary Disease 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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- • Diaphragmatic breathing technique, basic breathing technique
- Keywords
- dyspnea, pulmonary function testing, diaphragmatic training, abdominal training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
• Diaphragmatic breathing techniqueOther
Also called • Abdominal breathing technique
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
basic breathing techniqueOther
Deep Breathing for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: will be treated with basic breathing technique. Receives: Other: basic breathing technique |
| Group B | Experimental | Group B: will be treated by will be breathing technique along with diaphragm and abdominal training. Receives: Other: • Diaphragmatic breathing technique; Other: basic breathing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (1)
• 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.)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study startOct 2022 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajeeha Zia, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587829
- Sponsor's protocol ID
- Aqsa Minahil
- Status last verified
- Oct 2022
- First submitted
- 5 Sep 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32780415Magitta 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.
PubMed 29386343Langer 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.
PubMed 29543134Waatevik 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.
PubMed 22497532Masjedi 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.
PubMed 29755807Ko 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.
PubMed 27028990Yamaguti 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.
PubMed 22464088Xu 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.
PubMed 30458805Gosselink 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.
PubMed 21282809Lu 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.
PubMed 31719191Scherer 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.
PubMed 11069801Bostanci 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.
PubMed 30953791Wang 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.
PubMed 30813125Kim 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.
PubMed 28971051O'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.
PubMed 31673990
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm and Abdominal Muscle Training on Pulmonary Function Testing and Dyspnea Among Chronic Obstructive Pulmonary Disease Patients.
- ClinicalTrials.gov ID
- NCT05587829
- Acronym / sponsor ID
- Aqsa Minahil
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- dyspnea, pulmonary function testing, diaphragmatic training, abdominal training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: basic breathing techniqueGroup A: will be treated with basic breathing technique. |
| Group B | Experimental | Other: • Diaphragmatic breathing technique, Other: basic breathing techniqueGroup B: will be treated by will be breathing technique along with diaphragm and abdominal training. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| • Diaphragmatic breathing techniqueAlso: • Abdominal breathing techniqueIn 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 | Other | Group B |
| basic breathing techniqueDeep Breathing for 15 minutes | Other | Group A, Group B |
Primary outcome
• Spirometer for pulmonary function testing FVC
Time frame: 4 months
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
Time frame: 4 months
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.
1 secondary outcome
• Dyspnea MDP
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Background: PubMed 32780415Olloquequi 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.
- Background: PubMed 29386343Magitta 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.
- Background: PubMed 29543134Langer 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.
- Background: PubMed 22497532Waatevik 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.
- Background: PubMed 29755807Masjedi 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.
- Background: PubMed 27028990Ko 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.
- Background: PubMed 22464088Yamaguti 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.
- Background: PubMed 30458805Xu 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.
- Background: PubMed 21282809Gosselink 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.
- Background: PubMed 31719191Lu 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.
- Background: PubMed 11069801Scherer 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.
- Background: PubMed 30953791Bostanci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wajeeha Zia, PP-DPT principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing • Diaphragmatic breathing technique and basic breathing technique in people with Chronic Obstructive Pulmonary Disease, run by Riphah International University.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wajeeha Zia, PP-DPT (0323 4500788, wajeeha.zia@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Spirometer for pulmonary function testing FVC (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT05587829, which also lists 18 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 20 Oct 2022.