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

NCT06555445 | Not Yet Recruiting

• 1 other identifier: REC/RCR&AHS/23/0338
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Respiratory Muscles; Breathing Exercises; Dyspnea

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Other: BREATHING EXERCISE; Other: BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE

Interventions

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; BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE

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

BREATHING EXERCISE REGIMEN COUPLED WITH BREATHER DEVICE

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

National Hospital and medical center, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 28128970 BACKGROUND

• 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.

  PMID: 36604646 BACKGROUND

• 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.

  PMID: 35092746 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Sidra Afzal, PP-DPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IQBAL TARIQ, PHD

CONTACT

03338236752; iqbal.tariq@riphah.edu.pk

IMRAN AMJAD, PHD

CONTACT

03324390125; Imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)