The Effect of Pulmonary Rehabilitation on Bronchoscopic Volume Reduction Process Success

The data of patients undergoing bronchoscopic volume reduction procedure will be analyzed retrospectively. Patients will be divided into two groups as patients with and without Pulmonary Rehabilitation before the procedure, and changes in functional levels of patients will be compared.

Study Overview

• Status: Completed
• Conditions: Emphysema; Pulmonary Rehabilitation; Bronchoscopic Lung Volume Reduction
• Intervention / Treatment: Other: Pulmonary Rehabilitation; Other: Standart care

Detailed Description

The data of patients who underwent bronchoscopic volume reduction between January 2013 and March 2019 will be examined.

Patients will be divided into two groups as pulmonary rehabilitation applied (PR group) and not applied (Control group) before the procedure.

Changes in the parameters of initial and rehabilitation follow-up will be examined.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Between the ages of 18-75
• Patients with a diagnosis of emphysema and bronchoscopic procedures

Exclusion Criteria:

• Patients who develop complications related to the procedure after bronchoscopic procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulmonary Rehabilitation Group; Optimal medication and clinical follow-up plus Pulmonary rehabiltation	Other: Pulmonary Rehabilitation; Exercise training+ Optimal medication and clinical follow-up; Other: Standart care; Optimal medication and clinical follow-up
Active Comparator: Non-Pulmonary Rehabilitation Group; Optimal medication and clinical follow-up	Other: Standart care; Optimal medication and clinical follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six minute walking test	The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were asked to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating were measured, and the walking distance were recorded	20 minutes
Pulmonary Function Tests	PFTs were performed by using the Sensormedics model 2400 (Yorba Linda, CA, USA) spirometry device, and according to the American Thoracic Society (ATS) guidelines	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbonmonoxide diffusion test	It will performed in the pulmonary function test laboratory using Cosmed Quark PFT (USA) with single-breath technique	15 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): August 18, 2020
• Study Completion (Actual): August 18, 2020

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Emphysema
• Other Study ID Numbers: BLVR_PR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No