COPDNCT06555445
Effects of Breathing Exercises With and Without Inspiratory Muscle Training in COPD Patients
A study testing BREATHING EXERCISE and BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a major health issue that affects a large proportion of the population, especially those over 50 years old. It is characterized by breathlessness and reduced lung function. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- BREATHING EXERCISE and BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2024to 15 Dec 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 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be aged between 35 and 50 years (23).
- Be of any gender.
- Have a clinical diagnosis of COPD, severity ranging according to GOLD stages of COPD II to III stages (24).
- Have the functional ability to perform the prescribed breathing exercises and inspiratory muscle training (25).
- Demonstrate a willingness to participate in the study by providing informed consent
Who cannot join
- Diagnosed musculoskeletal disorders that could potentially interfere with the e execution of the exercises.
- Recent chest injuries that might complicate the respiratory function.
- Pregnancy, given the potential for altered respiratory mechanics and concerns for f fetal safety.
- Prior history of abdominal or pelvic surgeries, as these could affect diaphragmatic movement and overall respiratory function.
- A history of malignancy, due to the potential for compromised overall health status and related complications.
- Active or latent tuberculosis, to prevent exacerbating the condition and potentially spreading the infection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Hospital and medical center, Lahore
Lahore, Punjab Province, 54000
Sidra Afzal, PP-DPT, 03124378540, sidra.afzal@riphah.edu.pk
About this study
Official title: Effects of Breathing Exercises With and Without Inspiratory Muscle Training on Dyspnea, Lung Volumes and Lung Capacities in COPD Patients
Chronic Obstructive Pulmonary Disease (COPD) is a major health issue that affects a large proportion of the population, especially those over 50 years old. It is characterized by breathlessness and reduced lung function. It has been hypothesized that practicing specific breathing exercises could potentially alleviate these symptoms and enhance lung volumes and capacities. In addition, there is a lack of clarity on the effects of inspiratory muscle training along with these breathing exercises, warranting further investigation. To determine the effects of breathing exercises with and without inspiratory muscle training on dyspnea, lung volumes and lung capacities in COPD patients. A total of 46 patients, aged over 50, will be enrolled from National Hospital and medical center, Lahore and Ittefaq Hospital, Lahore. These patients will be randomly divided into two groups A and B: the first group will be assigned to perform only diaphragmatic and pursed lip breathing exercises daily for 2 months. In contrast, the second group will also receive breather, which will involve inhaling through a mouthpiece with variable resistance and using breath-holding techniques. The trial will follow strict ethical guidelines, with all participants providing informed consent. Outcomes will be measured through pulmonary function tests and the Modified Borg Dyspnea Scale. The study will also obtain the necessary approval from the respective ethical committees of the participating institutions. The data will be analyzed in SPSS 26.0.
- Conditions
- COPD
- Being tested
- BREATHING EXERCISE, BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE
- Keywords
- Respiratory Muscles, Breathing Exercises, Dyspnea
- 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.
BREATHING EXERCISEOther
Participants will be guided to adopt a deep breathing practice by emphasizing the use of the diaphragm muscle, thereby minimizing the contribution of accessory muscles during inspiration. This approach fosters the efficiency of respiratory mechanics, aiding in the mitigation of dyspnea symptoms. Participants are directed to undertake these exercises 2-3 times per day, dedicating 15-20 minutes per session, consistently over a period of 2 months. Pursed-Lip Breathing .This technique involves exhaling through semi-closed lips, creating a resistance that helps control the rate of exhalation and, thus, optimizes lung volumes and capacities. This exercise is recommended to be performed similarly to diaphragmatic breathing, 2-3 times daily for 15- 20 minutes per session for a period of 2 months
BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICEOther
The resistance on the BREATHER device will be adjusted to match each participant's abilities and progression. The resistance level will be challenging yet manageable, ensuring participant comfort. Each daily session will consist of 15-30 minutes with the BREATHER device and can be split into two shorter sessions if necessary. The total duration of this treatment protocol will span 2 months. The BREATHER device will be employed for both inspiratory and expiratory muscle training. Alongside the device usage, specific breathing exercises, such as diaphragmatic and pursed lip breathing, will be performed
| Study group | Role | What they receive |
|---|---|---|
| BREATHING EXERCISE | Experimental | The participants in group A will be engaging in structured breathing exercises, focusing on the following two techniques Diaphragmatic Breathing and Pursed Lip Breathing Receives: Other: BREATHING EXERCISE |
| BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE | Active comparator | Participants will use the BREATHER device daily, performing the routine 5-7 days per week Receives: Other: BREATHING EXERCISE; Other: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute Walk Test (6MWT)
The 6MWT is a simple and widely used exercise test that measures functional capacity. It provides an objective measure of the patient's ability to perform daily activities and is reflective of submaximal level of functional capacity. In a 6- minute Walk Test (6MWT), the distance covered will depend on the individual's current physical health, age, sex, and other factors. On average, healthy adults may be able to walk between 400 and 700 meters in six minutes. However, individuals with COPD or other respiratory conditions might cover significantly less distance. The test is designed to measure the individual's functional capacity, with the goal being to increase this distance over time through appropriate interventions.
Measured: baseline and fourth week
Modified Borg Dyspnea Scale:
The Modified Borg Dyspnea Scale is a self-reported scale that measures perceived exertion and breathlessness, also known as dyspnea. This scale plays a critical role in assessing how a patient's Chronic Obstructive Pulmonary Disease (COPD) is affecting their quality of life and ability to carry out daily activities.
Measured: baseline and fourth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Afzal, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555445
- Sponsor's protocol ID
- REC/RCR&AHS/23/0338
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 28128970Worth H, Buhl R, Criee CP, Kardos P, Guckel E, Vogelmeier CF. In 'real world' patients with COPD, exacerbation history, and not blood eosinophils, is the most reliable predictor of future exacerbations. Respir Res. 2023 Jan 5;24(1):2. doi: 10.1186/s12931-023-02311-x.
PubMed 36604646Kovacs G, Avian A, Bachmaier G, Troester N, Tornyos A, Douschan P, Foris V, Sassmann T, Zeder K, Lindenmann J, Brcic L, Fuchsjaeger M, Agusti A, Olschewski H. Severe Pulmonary Hypertension in COPD: Impact on Survival and Diagnostic Approach. Chest. 2022 Jul;162(1):202-212. doi: 10.1016/j.chest.2022.01.031. Epub 2022 Jan 31.
PubMed 35092746
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Exercises With and Without Inspiratory Muscle Training on Dyspnea, Lung Volumes and Lung Capacities in COPD Patients
- ClinicalTrials.gov ID
- NCT06555445
- Acronym / sponsor ID
- REC/RCR&AHS/23/0338
- Conditions
- COPD
- Keywords
- Respiratory Muscles, Breathing Exercises, Dyspnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 15 Aug 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 a major health issue that affects a large proportion of the population, especially those over 50 years old. It is characterized by breathlessness and reduced lung function. It has been hypothesized that practicing specific breathing exercises could potentially alleviate these symptoms and enhance lung volumes and capacities. In addition, there is a lack of clarity on the effects of inspiratory muscle training along with these breathing exercises, warranting further investigation. To determine the effects of breathing exercises with and without inspiratory muscle training on dyspnea, lung volumes and lung capacities in COPD patients. A total of 46 patients, aged over 50, will be enrolled from National Hospital and medical center, Lahore and Ittefaq Hospital, Lahore. These patients will be randomly divided into two groups A and B: the first group will be assigned to perform only diaphragmatic and pursed lip breathing exercises daily for 2 months. In contrast, the second group will also receive breather, which will involve inhaling through a mouthpiece with variable resistance and using breath-holding techniques. The trial will follow strict ethical guidelines, with all participants providing informed consent. Outcomes will be measured through pulmonary function tests and the Modified Borg Dyspnea Scale. The study will also obtain the necessary approval from the respective ethical committees of the participating institutions. The data will be analyzed in SPSS 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BREATHING EXERCISE | Experimental | Other: BREATHING EXERCISEThe participants in group A will be engaging in structured breathing exercises, focusing on the following two techniques Diaphragmatic Breathing and Pursed Lip Breathing |
| BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE | Active comparator | Other: BREATHING EXERCISE, Other: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICEParticipants will use the BREATHER device daily, performing the routine 5-7 days per week |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be aged between 35 and 50 years (23).
- Be of any gender.
- Have a clinical diagnosis of COPD, severity ranging according to GOLD stages of COPD II to III stages (24).
- Have the functional ability to perform the prescribed breathing exercises and inspiratory muscle training (25).
- Demonstrate a willingness to participate in the study by providing informed consent
Key exclusion criteria (6 listed)
- Diagnosed musculoskeletal disorders that could potentially interfere with the e execution of the exercises.
- Recent chest injuries that might complicate the respiratory function.
- Pregnancy, given the potential for altered respiratory mechanics and concerns for f fetal safety.
- Prior history of abdominal or pelvic surgeries, as these could affect diaphragmatic movement and overall respiratory function.
- A history of malignancy, due to the potential for compromised overall health status and related complications.
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 |
|---|---|---|
| BREATHING EXERCISEParticipants will be guided to adopt a deep breathing practice by emphasizing the use of the diaphragm muscle, thereby minimizing the contribution of accessory muscles during inspiration. This approach fosters the efficiency of respiratory mechanics, aiding in the mitigation of dyspnea symptoms. Participants are directed to undertake these exercises 2-3 times per day, dedicating 15-20 minutes per session, consistently over a period of 2 months. Pursed-Lip Breathing .This technique involves exhaling through semi-closed lips, creating a resistance that helps control the rate of exhalation and, thus, optimizes lung volumes and capacities. This exercise is recommended to be performed similarly to diaphragmatic breathing, 2-3 times daily for 15- 20 minutes per session for a period of 2 months | Other | BREATHING EXERCISE, BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE |
| BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICEThe resistance on the BREATHER device will be adjusted to match each participant's abilities and progression. The resistance level will be challenging yet manageable, ensuring participant comfort. Each daily session will consist of 15-30 minutes with the BREATHER device and can be split into two shorter sessions if necessary. The total duration of this treatment protocol will span 2 months. The BREATHER device will be employed for both inspiratory and expiratory muscle training. Alongside the device usage, specific breathing exercises, such as diaphragmatic and pursed lip breathing, will be performed | Other | BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE |
Primary outcome
6-minute Walk Test (6MWT)
Time frame: baseline and fourth week
The 6MWT is a simple and widely used exercise test that measures functional capacity. It provides an objective measure of the patient's ability to perform daily activities and is reflective of submaximal level of functional capacity. In a 6- minute Walk Test (6MWT), the distance covered will depend on the individual's current physical health, age, sex, and other factors. On average, healthy adults may be able to walk between 400 and 700 meters in six minutes. However, individuals with COPD or other respiratory conditions might cover significantly less distance. The test is designed to measure the individual's functional capacity, with the goal being to increase this distance over time through appropriate interventions.
Modified Borg Dyspnea Scale:
Time frame: baseline and fourth week
The Modified Borg Dyspnea Scale is a self-reported scale that measures perceived exertion and breathlessness, also known as dyspnea. This scale plays a critical role in assessing how a patient's Chronic Obstructive Pulmonary Disease (COPD) is affecting their quality of life and ability to carry out daily activities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 28128970Vogelmeier 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.
- Background: PubMed 36604646Worth H, Buhl R, Criee CP, Kardos P, Guckel E, Vogelmeier CF. In 'real world' patients with COPD, exacerbation history, and not blood eosinophils, is the most reliable predictor of future exacerbations. Respir Res. 2023 Jan 5;24(1):2. doi: 10.1186/s12931-023-02311-x.
- Background: PubMed 35092746Kovacs G, Avian A, Bachmaier G, Troester N, Tornyos A, Douschan P, Foris V, Sassmann T, Zeder K, Lindenmann J, Brcic L, Fuchsjaeger M, Agusti A, Olschewski H. Severe Pulmonary Hypertension in COPD: Impact on Survival and Diagnostic Approach. Chest. 2022 Jul;162(1):202-212. doi: 10.1016/j.chest.2022.01.031. Epub 2022 Jan 31.
- 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.
Sidra Afzal, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BREATHING EXERCISE and BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE 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 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 15 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IQBAL TARIQ, PHD (03338236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute Walk Test (6MWT) (time frame: baseline and fourth week). 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 NCT06555445, which also lists 3 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 15 Aug 2024.