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

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: Not yet recruiting
• Conditions: COPD
• Intervention / Treatment: Other: BREATHING EXERCISE; Other: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imran Amjad, PhD; Phone Number: 03324390125; Email: Imran.amjad@riphah.edu.pk
• Study Contact Backup: Name: Iqbal Tariq, phd; Phone Number: 03338236752; Email: Iqbal.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • National Hospital and medical center, Lahore
      • Contact: Sidra Afzal, PP-DPT; Phone Number: 03124378540; Email: sidra.afzal@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	baseline and fourth week

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sidra Afzal, PP-DPT, Riphah International University

Publications and helpful links

General 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.
• Worth 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.
• Kovacs 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Dyspnea; Breathing Exercises; Respiratory Muscles
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID 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