COPDNCT06308302
Comparative Effects of IMT Vs EMT Along With AIT in COPD Patients
A study testing Group A (Inspiratory Muscles Training + Aerobic Interval Training) and Group B (Expiratory Muscles Training +Aerobic Interval Training) in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Group A (Inspiratory Muscles Training + Aerobic Interval Training) and Group B (Expiratory Muscles Training +Aerobic Interval Training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePakistan
- Study dates
- 23 May 2023to 15 Feb 2024
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must have a diagnosed case of COPD.
- Participants must be between the ages of 30 and 55 years old.
- Participants must have GOLD II and III stage COPD.
- Both men and women are eligible for the study.
Who cannot join
- Participants with a history of cardiovascular disease.
- Participants with a history of neurological disease.
- Participants with a history of orthopaedic disease.
- Participants with a history of neuromuscular disease.
- Participants who had experienced a recent COPD exacerbation within the past 3 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al-Zahra Rehabilitation Center, Gulab Devi Teaching Hospital
Lahore, Punjab Province, 42000
About this study
Official title: Comparative Effects of Inspiratory Muscle Training vs Expiratory Muscle Training Along With Aerobic Interval Training on Functional Performance and Fatigue Level in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.
This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.
Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- COPD
- Being tested
- Group A (Inspiratory Muscles Training + Aerobic Interval Training), Group B (Expiratory Muscles Training +Aerobic Interval Training)
- Keywords
- Chronic Obstructive pulmonary disease, Dyspnea, Breathing Exercises, Pulmonary Disease, Fatigue, Functional Performance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Lung Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Inspiratory Muscles Training + Aerobic Interval Training)Other
Performed Inspiratory muscle training on a breather device (20), (10 inhales with maximum 3-sec hold), 3 sets with a 1-minute interval between each set, for 6 days a week along with aerobic interval training on alternate days (3 days a week for 20-25 minutes in 1st week, 30-35 minutes in 2nd week, 40 minutes in 3rd week, 45-60 minutes in 4th week each session). (120)
Baseline treatment given is Aerobic interval training and COPD medications.
Group B (Expiratory Muscles Training +Aerobic Interval Training)Other
Performed Expiratory muscle training along with aerobic interval training on alternate days (3 days a week for 20-25 minutes in 1st week, 30-35 minutes in 2nd week, 40-45 minutes in 3rd week, 45-60 minutes in 4th week per session). (120)
Baseline treatment given is Aerobic interval training and COPD medications.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A (Inspiratory Muscles Training +Aerobic Interval Training) Receives: Other: Group A (Inspiratory Muscles Training + Aerobic Interval Training) |
| Group B | Experimental | Group B (Expiratory Muscles Training +Aerobic Interval Training) Receives: Other: Group B (Expiratory Muscles Training +Aerobic Interval Training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council (mMRC) Dyspnea Scale
A widely recognized tool for evaluating the level of breathlessness experienced by patients with COPD. It provides a simple and efficient method of assessing the baseline functional disability due to dyspnea. experiencing breathlessness with strenuous exercise.
The scale ranges from 0 to 4, with each grade representing a different level of breathlessness, from only experiencing breathlessness with strenuous exercise (Grade 0) to being too breathless to leave the house or experiencing breathlessness when dressing or undressing (Grade 4).
Measured: 4 Weeks
6 Minute Walk Test
The 6-Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance, particularly in patients with COPD. The score of the 6MWT is the distance a patient walks in 6 minutes. The patient may take as many standing rests as they like, but the timer should keep going. The 6MWT measures exercise tolerance in people with various health conditions.
Measured: 4 Weeks
Karnofsky Performance Scale (KPS)
The Karnofsky Performance Scale (KPS) is an assessment tool used to predict the length of survival in terminally ill patients.It's an 11-point rating scale ranging from normal functioning (100) to dead (0) in ten-point increments. The higher the score, the more independent the person is.
Measured: 4 Weeks
Fatigue Severity Scale (FSS)
A tool used to measure the severity of fatigue in patients with Chronic Obstructive Pulmonary Disease (COPD). It's a 9-item questionnaire where each item is scored on a 7-point scale, with 1 indicating strong disagreement and 7 indicating strong agreement. The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity.
Measured: 4 week
FEV1
A Digital Spirometer is a device used to measure the volume and speed of air a person can inhale and exhale. It is often used to diagnose and monitor conditions like COPD. The spirometer measures the Forced Expiratory Volume in 1 second (FEV1), which is how much air you can exhale in the first second after a full inhalation. The FEV1 and FVC values are used to diagnose conditions like COPD.
Measured: 4 Weeks
FVC
Digital Spirometer will be used to measure the volume and speed of air a person can inhale and exhale. The spirometer measures the Forced Vital Capacity (FVC), which is the largest amount of air that you can forcefully exhale after breathing in as deeply as you can. Pre-post reading will be taken. it is measures in liters.
Measured: 4 weeks
FEV1/FVC
Digital Spirometer is a device used to measure the volume and speed of air a person can inhale and exhale. The FEV1 and FVC values are used to diagnose conditions like COPD. The ratio of FEV1 to FVC (FEV1/FVC) is calculated and expressed as a percentage. Pre-Post readings will be taken.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start23 May 2023
- Primary completion30 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Muriam Ghani, MSCPPT, Principal investigator, Ripha International University-LHR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308302
- Sponsor's protocol ID
- REC/RCR&AHS/23/0355
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 35279265Landt E, Colak Y, Lange P, Laursen LC, Nordestgaard BG, Dahl M. Chronic Cough in Individuals With COPD: A Population-Based Cohort Study. Chest. 2020 Jun;157(6):1446-1454. doi: 10.1016/j.chest.2019.12.038. Epub 2020 Jan 25.
PubMed 31987882Gutierrez Villegas C, Paz-Zulueta M, Herrero-Montes M, Paras-Bravo P, Madrazo Perez M. Cost analysis of chronic obstructive pulmonary disease (COPD): a systematic review. Health Econ Rev. 2021 Aug 17;11(1):31. doi: 10.1186/s13561-021-00329-9.
PubMed 34403023Chen S, Kuhn M, Prettner K, Yu F, Yang T, Barnighausen T, Bloom DE, Wang C. The global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a health-augmented macroeconomic modelling study. Lancet Glob Health. 2023 Aug;11(8):e1183-e1193. doi: 10.1016/S2214-109X(23)00217-6.
PubMed 37474226Agarwal D. COPD generates substantial cost for health systems. Lancet Glob Health. 2023 Aug;11(8):e1138-e1139. doi: 10.1016/S2214-109X(23)00304-2. No abstract available.
PubMed 37474208Carter P, Lagan J, Fortune C, Bhatt DL, Vestbo J, Niven R, Chaudhuri N, Schelbert EB, Potluri R, Miller CA. Association of Cardiovascular Disease With Respiratory Disease. J Am Coll Cardiol. 2019 May 7;73(17):2166-2177. doi: 10.1016/j.jacc.2018.11.063. Epub 2019 Mar 4.
PubMed 30846341Hughes MJ, McGettrick HM, Sapey E. Shared mechanisms of multimorbidity in COPD, atherosclerosis and type-2 diabetes: the neutrophil as a potential inflammatory target. Eur Respir Rev. 2020 Mar 20;29(155):190102. doi: 10.1183/16000617.0102-2019. Print 2020 Mar 31.
PubMed 32198215Li Y, Gao H, Zhao L, Wang J. Osteoporosis in COPD patients: Risk factors and pulmonary rehabilitation. Clin Respir J. 2022 Jul;16(7):487-496. doi: 10.1111/crj.13514. Epub 2022 Jun 10.
PubMed 35688435Li Z, Liu S, Wang L, Smith L. Mind-Body Exercise for Anxiety and Depression in COPD Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Dec 18;17(1):22. doi: 10.3390/ijerph17010022.
PubMed 31861418Zou M, Zhang W, Xu Y, Zhu Y. Relationship Between COPD and GERD: A Bibliometrics Analysis. Int J Chron Obstruct Pulmon Dis. 2022 Dec 6;17:3045-3059. doi: 10.2147/COPD.S391878. eCollection 2022.
PubMed 36510485
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Inspiratory Muscle Training vs Expiratory Muscle Training Along With Aerobic Interval Training on Functional Performance and Fatigue Level in COPD Patients
- ClinicalTrials.gov ID
- NCT06308302
- Acronym / sponsor ID
- REC/RCR&AHS/23/0355
- Conditions
- COPD
- Keywords
- Chronic Obstructive pulmonary disease, Dyspnea, Breathing Exercises, Pulmonary Disease, Fatigue, Functional Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 13 Mar 2024 (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.
Chronic Obstructive Pulmonary Disease (COPD) is the 3rd leading cause of mortality and 7th leading cause of ill-health worldwide. It is characterized by persistent and progressive air flow resistance with expiratory flow more compromised as compared to inspiratory flow leading to CO2 retention and prominent hyperinflation of lungs. The overall effects of COPD on the patient's entire body include pulmonary, followed by extra-pulmonary manifestations in which musculoskeletal derangements are more pronounced and interfere with daily activities, further deteriorating the patient's health. Restricted air flow leads to an increase in shortness of breath on slight exertion and early fatigue or exhaustion of respiratory muscles due to over work. Literature from the past describes how COPD care has advanced and emphasizes the value of pulmonary rehabilitation in addition to medicinal management to treat decadence. Many studies show that Inspiratory muscle training has positive effect on ABG's, some PFT's and diaphragmatic function. Endurance and strength training improve patient activity of daily living and dyspnea.
This study intricate the collation of Respiratory Muscle Training and Aerobic Interval Training on functional performance, exertional dyspnea and fatigue level in patients diagnosed with COPD. A randomized controlled trial will be integrated with the sample size of 53 patients which is calculated through epi-tool. Age of selected Patients will fall between 30-55 years and will be randomly assigned into 2 groups. Group A (Experimental group A) will get Inspiratory breather training along-with Aerobic Interval Training, Group B (Experimental group B) will get Expiratory muscle training along-with Aerobic Interval Training (Same Protocol). Data will be gathered from Pulmonology wards and OPD of selected hospital. Clinical Assessment will be incorporated through Karnofsky performance scale, Fatigue Severity Scale, MmRC Dyspnea scale, Digital Spirometer, and 6MWT. Pre-intervention assessment measures and Post-intervention measures will be noted and results will be compared. Study Duration will be of 06 months after approval of synopsis. Data analysis will be done through SPSS.
Key words: Aerobic Interval training (AIT), The Breather Device (BD), 6-min walk test (6MWT), Fatigue severity scale (FSS), Modified Medical Research Council dyspnea scale (mMRC), Chronic Obstructive Pulmonary Disease (COPD).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Group A (Inspiratory Muscles Training + Aerobic Interval Training)Group A (Inspiratory Muscles Training +Aerobic Interval Training) |
| Group B | Experimental | Other: Group B (Expiratory Muscles Training +Aerobic Interval Training)Group B (Expiratory Muscles Training +Aerobic Interval Training) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must have a diagnosed case of COPD.
- Participants must be between the ages of 30 and 55 years old.
- Participants must have GOLD II and III stage COPD.
- Both men and women are eligible for the study.
Key exclusion criteria (5 listed)
- Participants with a history of cardiovascular disease.
- Participants with a history of neurological disease.
- Participants with a history of orthopaedic disease.
- Participants with a history of neuromuscular disease.
- Participants who had experienced a recent COPD exacerbation within the past 3 months.
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 |
|---|---|---|
| Group A (Inspiratory Muscles Training + Aerobic Interval Training)Performed Inspiratory muscle training on a breather device (20), (10 inhales with maximum 3-sec hold), 3 sets with a 1-minute interval between each set, for 6 days a week along with aerobic interval training on alternate days (3 days a week for 20-25 minutes in 1st week, 30-35 minutes in 2nd week, 40 minutes in 3rd week, 45-60 minutes in 4th week each session). (120) Baseline treatment given is Aerobic interval training and COPD medications. | Other | Group A |
| Group B (Expiratory Muscles Training +Aerobic Interval Training)Performed Expiratory muscle training along with aerobic interval training on alternate days (3 days a week for 20-25 minutes in 1st week, 30-35 minutes in 2nd week, 40-45 minutes in 3rd week, 45-60 minutes in 4th week per session). (120) Baseline treatment given is Aerobic interval training and COPD medications. | Other | Group B |
Primary outcome
Modified Medical Research Council (mMRC) Dyspnea Scale
Time frame: 4 Weeks
A widely recognized tool for evaluating the level of breathlessness experienced by patients with COPD. It provides a simple and efficient method of assessing the baseline functional disability due to dyspnea. experiencing breathlessness with strenuous exercise. The scale ranges from 0 to 4, with each grade representing a different level of breathlessness, from only experiencing breathlessness with strenuous exercise (Grade 0) to being too breathless to leave the house or experiencing breathlessness when dressing or undressing (Grade 4).
6 Minute Walk Test
Time frame: 4 Weeks
The 6-Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance, particularly in patients with COPD. The score of the 6MWT is the distance a patient walks in 6 minutes. The patient may take as many standing rests as they like, but the timer should keep going. The 6MWT measures exercise tolerance in people with various health conditions.
Karnofsky Performance Scale (KPS)
Time frame: 4 Weeks
The Karnofsky Performance Scale (KPS) is an assessment tool used to predict the length of survival in terminally ill patients.It's an 11-point rating scale ranging from normal functioning (100) to dead (0) in ten-point increments. The higher the score, the more independent the person is.
Fatigue Severity Scale (FSS)
Time frame: 4 week
A tool used to measure the severity of fatigue in patients with Chronic Obstructive Pulmonary Disease (COPD). It's a 9-item questionnaire where each item is scored on a 7-point scale, with 1 indicating strong disagreement and 7 indicating strong agreement. The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity.
FEV1
Time frame: 4 Weeks
A Digital Spirometer is a device used to measure the volume and speed of air a person can inhale and exhale. It is often used to diagnose and monitor conditions like COPD. The spirometer measures the Forced Expiratory Volume in 1 second (FEV1), which is how much air you can exhale in the first second after a full inhalation. The FEV1 and FVC values are used to diagnose conditions like COPD.
FVC
Time frame: 4 weeks
Digital Spirometer will be used to measure the volume and speed of air a person can inhale and exhale. The spirometer measures the Forced Vital Capacity (FVC), which is the largest amount of air that you can forcefully exhale after breathing in as deeply as you can. Pre-post reading will be taken. it is measures in liters.
FEV1/FVC
Time frame: 4 weeks
Digital Spirometer is a device used to measure the volume and speed of air a person can inhale and exhale. The FEV1 and FVC values are used to diagnose conditions like COPD. The ratio of FEV1 to FVC (FEV1/FVC) is calculated and expressed as a percentage. Pre-Post readings will be taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 35279265Adeloye 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.
- Background: PubMed 31987882Landt E, Colak Y, Lange P, Laursen LC, Nordestgaard BG, Dahl M. Chronic Cough in Individuals With COPD: A Population-Based Cohort Study. Chest. 2020 Jun;157(6):1446-1454. doi: 10.1016/j.chest.2019.12.038. Epub 2020 Jan 25.
- Background: PubMed 34403023Gutierrez Villegas C, Paz-Zulueta M, Herrero-Montes M, Paras-Bravo P, Madrazo Perez M. Cost analysis of chronic obstructive pulmonary disease (COPD): a systematic review. Health Econ Rev. 2021 Aug 17;11(1):31. doi: 10.1186/s13561-021-00329-9.
- Background: PubMed 37474226Chen S, Kuhn M, Prettner K, Yu F, Yang T, Barnighausen T, Bloom DE, Wang C. The global economic burden of chronic obstructive pulmonary disease for 204 countries and territories in 2020-50: a health-augmented macroeconomic modelling study. Lancet Glob Health. 2023 Aug;11(8):e1183-e1193. doi: 10.1016/S2214-109X(23)00217-6.
- Background: PubMed 37474208Agarwal D. COPD generates substantial cost for health systems. Lancet Glob Health. 2023 Aug;11(8):e1138-e1139. doi: 10.1016/S2214-109X(23)00304-2. No abstract available.
- Background: PubMed 30846341Carter P, Lagan J, Fortune C, Bhatt DL, Vestbo J, Niven R, Chaudhuri N, Schelbert EB, Potluri R, Miller CA. Association of Cardiovascular Disease With Respiratory Disease. J Am Coll Cardiol. 2019 May 7;73(17):2166-2177. doi: 10.1016/j.jacc.2018.11.063. Epub 2019 Mar 4.
- Background: PubMed 32198215Hughes MJ, McGettrick HM, Sapey E. Shared mechanisms of multimorbidity in COPD, atherosclerosis and type-2 diabetes: the neutrophil as a potential inflammatory target. Eur Respir Rev. 2020 Mar 20;29(155):190102. doi: 10.1183/16000617.0102-2019. Print 2020 Mar 31.
- Background: PubMed 35688435Li Y, Gao H, Zhao L, Wang J. Osteoporosis in COPD patients: Risk factors and pulmonary rehabilitation. Clin Respir J. 2022 Jul;16(7):487-496. doi: 10.1111/crj.13514. Epub 2022 Jun 10.
- Background: PubMed 31861418Li Z, Liu S, Wang L, Smith L. Mind-Body Exercise for Anxiety and Depression in COPD Patients: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Dec 18;17(1):22. doi: 10.3390/ijerph17010022.
- Background: PubMed 36510485Zou M, Zhang W, Xu Y, Zhu Y. Relationship Between COPD and GERD: A Bibliometrics Analysis. Int J Chron Obstruct Pulmon Dis. 2022 Dec 6;17:3045-3059. doi: 10.2147/COPD.S391878. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Hafiza Muriam Ghani, MSCPPT principal investigator
Ripha International University-LHR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A (Inspiratory Muscles Training + Aerobic Interval Training) and Group B (Expiratory Muscles Training +Aerobic Interval Training) in people with COPD, 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 5 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 Mar 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?
Modified Medical Research Council (mMRC) Dyspnea Scale (time frame: 4 Weeks). The study lists 7 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 NCT06308302, which also lists 10 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 Mar 2024.