Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure

NCT ID: NCT05540054

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-01

Brief Summary

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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

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* 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.

Conditions

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Copd IMT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard pulmonary rehabilitation group (PR)

Patients diagnosed with COPD and listed for bronchoscopic procedure.

Group Type EXPERIMENTAL

Standard pulmonary rehabilitation programme

Intervention Type OTHER

The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.

Inspiratory muscle training group (PR+IMT)

Patients diagnosed with COPD and listed for bronchoscopic procedure.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device.

Standard pulmonary rehabilitation programme

Intervention Type OTHER

The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.

Interventions

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Inspiratory muscle training

Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device.

Intervention Type OTHER

Standard pulmonary rehabilitation programme

The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Esra Pehlivan

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BLVR_IMT

Identifier Type: -

Identifier Source: org_study_id