NCT06259188

Effectiveness of Personalized Breathing Exercise Device in Patients With COPD

Investigation of the Effectiveness of Personalized Breathing Exercise Device in Patients With COPD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The current "Global Initiative for Chronic Obstructive Lung Diseases" (GOLD) guideline emphasizes that pulmonary rehabilitation should be recommended to all chronic obstructive pulmonary disease (COPD) patients from Stage II onwards. Respiratory muscle training applied to individuals with COPD is an important part of pulmonary rehabilitation due to its benefits such as improving pulmonary function and respiratory muscle strength, reducing the severity of dyspnea, and increasing exercise capacity and quality of life. Although there is sufficient evidence in the literature about the benefits of IMT in individuals with COPD. There is little evidence showing the effects of EMT. Studies show that isolated IMT and EMT are effective in increasing respiratory muscle strength, endurance and exercise capacity. Results from a limited number of studies show that combined training of IMT and EMT is superior compared to isolated IMT or isolated EMT in improving exercise capacity and dyspnea. Incentive spirometers, with their different mechanical properties, are low-cost respiratory exercise devices that are widely used in the early postoperative period, lung diseases, long-term bed rest and in situations where it is necessary to maintain or increase the ventilation ability of the lung, but they do not apply any resistance to the respiratory muscles. In the pulmonary rehabilitation guidelines published by the American Thoracic Society (ATS) and the European Respiratory Society (ERS), the necessity of using devices that apply resistance to the respiratory muscles to strengthen the respiratory muscles is underlined. The personalized respiratory exercise device will be a device that has the clinical features of an incentive spirometer and respiratory muscle training devices (inspiratory and expiratory) and can be personalized according to the desired purpose. With the same device, patients will be able to both improve lung ventilation, such as an incentive spirometer, and strengthen their respiratory muscles.

Conditions

• Chronic Obstructive Pulmonary Disease
• Inspiratory Muscle Training
• Expiratory Muscle Training

Interventions

Type	Name	Description
DEVICE	Respiratory Muscle Training Device	In the both groups the initial pressure load will be set to the resistance level corresponding to the 40% of the MIP and MEP measurement. Participants will be asked to rest following 5 breathing cycles and repeat the training for 10 sets. In each set, there will be a one-minute rest break between repetitions. In breathing exercise device group participants will be able to practice both inspiratory and expiratory respiratory muscle training in a single breathing cycle. In IMT+EMT group, patients will be able to practice different to device. As the progression progresses, the perceived exertion level will be increased by 5-10% every week, to be in the range of 4-6 according to the Modified Borg scale.
DEVICE	Personalized Breathing Exercise Device	Personalized Breathing Exercise Device

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-05-29
• Completion: 2025-05-29
• First posted: 2024-02-14
• Last updated: 2024-10-08

Locations

1 site across 1 country: Turkey (Türkiye)