Clinical trial NCT06555445: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
Keywords: Respiratory Muscles
Breathing Exercises
Dyspnea
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 6-minute Walk Test (6MWT)
timeFrame: baseline and fourth week
measure: Modified Borg Dyspnea Scale:
timeFrame: baseline and fourth week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: National Hospital and medical center, Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sidra Afzal, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.