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NCT Number: NCT06555445

Effects of Breathing Exercises With and Without Inspiratory Muscle Training 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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Hospital and medical center, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location contact

Sidra Afzal, PP-DPT

CONTACT

[email protected]

03124378540

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breathing exercise

Other

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 DEVICE

Other

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PHD

CONTACT

[email protected]

03324390125

IQBAL TARIQ, PHD

CONTACT

[email protected]

03338236752

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Breathing Exercises With and Without Inspiratory Muscle Training on Dyspnea, Lung Volumes and Lung Capacities in COPD Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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