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

Not Applicable

Not yet recruiting

• Conditions: COPD
• Interventions: Other: BREATHING EXERCISE; Other: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE

• Registration Number: NCT06555445
• Lead Sponsor: Riphah International University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study Start: 2024-08-15
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2024-11-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE	BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE	Participants will use the BREATHER device daily, performing the routine 5-7 days per week
BREATHING EXERCISE	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
BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE	BREATHING EXERCISE	Participants will use the BREATHER device daily, performing the routine 5-7 days per week

Primary Outcome Measures

Name	Time	Method
6-minute Walk Test (6MWT)	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:	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.

Trial Locations

Locations (1)

National Hospital and medical center, Lahore; 🇵🇰 Lahore, Punjab, Pakistan