NCT03518177

Brief Summary

The recent years, the use of bronchoscopic lung volume reduction in emphysema patients instead of surgical operations has become widespread. Before this procedure, the implementation of Pulmonary Rehabilitation became a necessity. The inadequacy of the number of Pulmonary Rehabilitation Centers in our country and in our city and the increasing number of mentioned operations have increased the need for different exercise program applications. Prior to valve and coil applications in our study, changes in clinical conditions of patients will be examined if Pulmonary Rehabilitation is performed at home or in a hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

April 25, 2018

Last Update Submit

March 6, 2019

Conditions

EmphysemaBronchoscopic Lung Volume ReductionHospital-based Pulmonary RehabilitationHome-based Pulmonary Rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Change from baseline distance covered in six-minute walk test at 8 weeks

    8 weeks

  • Change from baseline modified Medical Council Dyspnea score at 8 weeks

    The scale will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.

    8 weeks

  • Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 8 weeks

    The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.

    8 weeks

  • Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

    8 weeks

Study Arms (2)

Hospital-based PR group

EXPERIMENTAL

The patient will receive an 8-week supervised Pulmonary Rehabilitation Exercise Program at hospital

Other: Hospital-based pulmonary rehabilitation

Home-based PR group

EXPERIMENTAL

The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program at home

Other: Home-based pulmonary rehabilitation

Interventions

Hospital-based pulmonary rehabilitationOTHER

The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, treadmill walking, cycle ergometer, arm ergometer training and strengthening trainning with free weights at hospital.

Hospital-based PR group
Home-based pulmonary rehabilitationOTHER

The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home

Home-based PR group

Eligibility Criteria

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

You may qualify if:

  • Patients with emphysema and bronchoscopic lung volume reduction procedures decided by chest physician
  • Acceptance of participation in a 2-month Pulmonary Rehabilitation program.

You may not qualify if:

  • Possible orthopedic, cardiovascular or psychological disturbance that may prevent exercising.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

Related Publications (1)

  • Pehlivan E, Yazar E, Balci A, Turan D, Demirkol B, Cetinkaya E. A comparative study of the effectiveness of hospital-based versus home-based pulmonary rehabilitation in candidates for bronchoscopic lung volume reduction. Heart Lung. 2020 Nov-Dec;49(6):959-964. doi: 10.1016/j.hrtlng.2020.06.011. Epub 2020 Jul 21.

    PMID: 32709500DERIVED

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
Model Details: Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation(Group 2).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 8, 2018

Study Start

May 15, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

TU(1)