Effectiveness of Personalized Breathing Exercise Device in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06259188
• Other study ID #: 1001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: May 29, 2025

Study information

• Verified date: February 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Ozge Ertan
• Phone: +902124141500
• Email: ozge.ertann[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: May 29, 2025
• Est. primary completion date: May 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Inspiratory Muscle Training
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• Personalized Breathing Exercise Device
Personalized Breathing Exercise Device

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)	Biruni University, Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal static inspiratory mouth pressure	Measurement will be made with a respiratory muscle strength measuring device. MIP: maximal inspiratory pressure	1 week-8 week
Primary	Maximal static expiratory mouth pressure	Measurement will be made with a respiratory muscle strength measuring device. MEP: maximal expiratory pressure	1 week-8 week
Secondary	Respiratory Functions	Pulmonary function test: FEV1 L and %	1 week-8 week
Secondary	Respiratory Functions	Pulmonary function test: FVC L and %	1 week-8 week
Secondary	Respiratory Functions	Pulmonary function test: FEV1/FVC%	1 week-8 week
Secondary	Respiratory Functions	Pulmonary function test: PEF L/S and %	1 week-8 week
Secondary	Diffusion Capacity	Pulmonary function test: DLCO%	1 week-8 week
Secondary	Exercise capacity	Spiropalm six minute walk test	1 week-8 week
Secondary	Activities of daily living	London Chest Activities of Daily Living Scale (LCADL): Perceived dyspnea while performing activities of daily living is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum total score 0 and maximum total score is 75.	1 week-8 week
Secondary	Activity Status	Duke Activity Status Index: The Duke Activity Status Index (DASI) is a patient-reported estimate of functional capacity, maximal oxygen consumption (VO2 max) and maximum metabolic equivalent of tasks (METs). The DASI questionnaire produces a score between 0 and 58.2 points	1 week-8 week
Secondary	Device ease of use	5-Likert Scale: Scoring will be determined as 1- "very difficult to use" and 5- "very easy to use".	8 week