Clinical trial NCT06259188: Effectiveness of Personalized Breathing Exercise Device in Patients With COPD
Official title: Investigation of the Effectiveness of Personalized Breathing Exercise Device in Patients With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Inspiratory Muscle Training
Expiratory Muscle Training
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Biruni University
name: The Scientific and Technological Research Council of Turkey
name: Istanbul University
First posted: 2024-02-14
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with COPD by a pulmonologist according to GOLD 2022 diagnostic criteria (GOLD, 2022) and in classes B, C and D according to GOLD
* Followed for at least 6 months
* Clinically stable patients without exacerbations or infections

Exclusion Criteria:

* Patients with a history of spontaneous or trauma-related pneumothorax
* Patients with middle ear-related pathologies (such as tympanic membrane rupture, otitis)
* Orthopedic and neurological problems that may interfere with exercise training
* Changes in medical treatment during the study
* Patients with unstable concomitant cardiac disease
* Patients who have been involved in another pulmonary rehabilitation program within the last 6 months
* Insufficient cooperation

Primary outcomes:
measure: Maximal static inspiratory mouth pressure
timeFrame: 1 week-8 week
measure: Maximal static expiratory mouth pressure
timeFrame: 1 week-8 week
Secondary outcomes:
measure: Respiratory Functions FEV1
timeFrame: 1 week-8 week
measure: Respiratory Functions FVC
timeFrame: 1 week-8 week
measure: Respiratory Functions FEV1/FVC
timeFrame: 1 week-8 week
measure: Respiratory Functions PEF
timeFrame: 1 week-8 week
measure: Diffusion Capacity
timeFrame: 1 week-8 week
measure: Exercise capacity
timeFrame: 1 week-8 week
measure: Activities of daily living
timeFrame: 1 week-8 week
measure: Activity Status
timeFrame: 1 week-8 week
measure: Device ease of use
timeFrame: 8 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ozge Ertan
role: PRINCIPAL_INVESTIGATOR
References: