Effects of Breathing Exercises With and Without Inspiratory Muscle Training in COPD Patients

August 13, 2024 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • National Hospital and medical center, Lahore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BREATHING EXERCISE
The participants in group A will be engaging in structured breathing exercises, focusing on the following two techniques Diaphragmatic Breathing and Pursed Lip Breathing
Other: BREATHING EXERCISE
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
Active Comparator: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE
Participants will use the BREATHER device daily, performing the routine 5-7 days per week
Other: BREATHING EXERCISE
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
Other: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline and fourth week
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.
baseline and fourth week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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