Clinical trial NCT05540054: Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure
Official title: Investigation of Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure in Chronic Obstructive Pulmonary Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
IMT
Keywords: IMT
COPD
pulmonary rehabilitation
bronchoscopic procedure
Bronchoscopic lung volume reduction
valve
coil
balloon
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effectiveness of inspiratory muscle training (IMT) before bronchoscopic procedure in Chronic Obstructive Pulmonary Patients (COPD). Patients with a diagnosis of COPD, who are listed for a bronchoscopic procedure and referred to the pulmonary rehabilitation (PR) clinic, will be randomly divided into two groups. Standard PR exercise program will be applied to both groups. In addition to the standard program, IMT will be applied to one of the groups. The effect of IMT on exercise program gains will be examined.

Detailed description: * Cases diagnosed with COPD by a chest diseases specialist at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital will be included in the study.
* The cases meeting the inclusion criteria will be randomized and divided into two groups, called the standard rehabilitation group (PRGr) and the inspiratory muscle training group (IMTGr).
* Initial exercise sessions and all evaluations of all cases will be performed in the hospital. The 2nd and 3rd training repetitions will be held at their homes via online synchronized videoconferencing. The exercise video will be sent to the smart phones of the cases who have completed 3 training sessions. Participants will be called once a week by phone and exercise follow-up will be carried out.
* All subjects will continue to exercise 5 days a week for 2 months. The standard PR consists of breathing exercises, peripheral muscle strength and self walking training. In addition, IMT was applied to IMTGr.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-75
* Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to -American Thoracic and European Respiratory Societies (ATS-ERS) and being a candidate patient for bronchoscopic lung volume reduction procedure
* Presence of dyspnea on exertion
* Stable clinical state at the time of inclusion without infection or exacerbation in the previous 4 weeks
* Ability to use a smart phone

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\min).
* A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
* Participation in a pulmonary rehabilitation program within the past 12 months.

Primary outcomes:
measure: Exercise capacity
timeFrame: Change from baseline at 2 months
measure: Dyspnea perception
timeFrame: Change from baseline at 2 months
measure: Respiratory muscle strength
timeFrame: Change from baseline at 2 months
measure: Clinical status follow-up after bronchoscopic procedure
timeFrame: Change from baseline at 1 year after bronchoscopic procedure
Secondary outcomes:
measure: Fatigue severity
timeFrame: Change from baseline at 2 months
measure: Physical activity level
timeFrame: Change from baseline at 2 months
measure: Anxiety level
timeFrame: Change from baseline at 2 months
measure: Depression level
timeFrame: Change from baseline at 2 months
measure: Quality of life level
timeFrame: Change from baseline at 2 months
measure: Pulmonary function tests (PFTs)
timeFrame: Change from baseline at 2 months
measure: Peripheral muscle strength measurement
timeFrame: Change from baseline at 2 months
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Esra Pehlivan
state: Üsküdar
Study officials:
References: