NCT04347044

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2020

Completed
Last Updated

August 19, 2020

Status Verified

April 1, 2020

Enrollment Period

7.6 years

First QC Date

April 13, 2020

Last Update Submit

August 18, 2020

Conditions

EmphysemaPulmonary RehabilitationBronchoscopic Lung Volume Reduction

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Carbonmonoxide diffusion test

    15 minutes

Study Arms (2)

Pulmonary Rehabilitation Group

EXPERIMENTAL

Optimal medication and clinical follow-up plus Pulmonary rehabiltation

Other: Pulmonary RehabilitationOther: Standart care

Non-Pulmonary Rehabilitation Group

ACTIVE COMPARATOR

Optimal medication and clinical follow-up

Other: Standart care

Interventions

Pulmonary RehabilitationOTHER

Exercise training+ Optimal medication and clinical follow-up

Pulmonary Rehabilitation Group
Standart careOTHER

Optimal medication and clinical follow-up

Non-Pulmonary Rehabilitation GroupPulmonary Rehabilitation Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

April 13, 2020

First Posted

April 15, 2020

Study Start

January 1, 2013

Primary Completion

August 18, 2020

Study Completion

August 18, 2020

Last Updated

August 19, 2020

Record last verified: 2020-04