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

Official title

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

Overview

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.

Interventions

• 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 exhal
• 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 de

Primary outcome measures

• 6-minute Walk Test (6MWT) [Time frame: baseline and fourth week]
• Modified Borg Dyspnea Scale: [Time frame: baseline and fourth week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• National Hospital and medical center, Lahore — Lahore

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 Respi PMID 28128970
• 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
• 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

Identifiers

NCT: NCT06555445 · REC/RCR&AHS/23/0338

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗