Chronic Obstructive Pulmonary Disease, Expiratory Muscle Training, Inspiratory Muscle Training
Conditions
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.
Interventions
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.
DEVICEPersonalized Breathing Exercise Device
Personalized Breathing Exercise Device
Sponsors
Biruni University
The Scientific and Technological Research Council of Turkey
Istanbul University
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal static inspiratory mouth pressure | 1 week-8 week | Measurement will be made with a respiratory muscle strength measuring device. MIP: maximal inspiratory pressure |
| Maximal static expiratory mouth pressure | 1 week-8 week | Measurement will be made with a respiratory muscle strength measuring device. MEP: maximal expiratory pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Functions FEV1/FVC | 1 week-8 week | Pulmonary function test: FEV1/FVC% |
| Respiratory Functions PEF | 1 week-8 week | Pulmonary function test: PEF L/S and % |
| Diffusion Capacity | 1 week-8 week | Pulmonary function test: DLCO% |
| Respiratory Functions FEV1 | 1 week-8 week | Pulmonary function test: FEV1 L and % |
| Activities of daily living | 1 week-8 week | 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. |
| Activity Status | 1 week-8 week | 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 |
| Device ease of use | 8 week | 5-Likert Scale: Scoring will be determined as 1- very difficult to use and 5- very easy to use. |
| Exercise capacity | 1 week-8 week | Spiropalm six minute walk test |
| Respiratory Functions FVC | 1 week-8 week | Pulmonary function test: FVC L and % |
Countries
Turkey (Türkiye)
Contacts
Primary ContactOzge Ertan
Backup ContactBuket Akıncı
Outcome results
None listed