Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR

Emphysema Clinical Trial

Official title:

Comparison of the Effectiveness of Home and Supervised Pulmonary Rehabilitation in Candidate Patients With Bronchoscopic Lung Volume Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518177
• Other study ID #: esra pehlivan
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2019
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The records of emphysema patients referred to the Pulmonary Rehabilitation Unit for prophylactic pulmonary rehabilitation prior to bronchoscopic lung volume reduction will be recorded prospectively. Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation (Group 2). The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program and will be reevaluated after 8 weeks. The differences in the parameters of initial and rehabilitation end-tracing and the differences between the groups will be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with emphysema and bronchoscopic lung volume reduction procedures decided by chest physician

• Acceptance of participation in a 2-month Pulmonary Rehabilitation program.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bronchoscopic Lung Volume Reduction
• Emphysema
• Home-based Pulmonary Rehabilitation
• Hospital-based Pulmonary Rehabilitation

Intervention

Other:
• Hospital-based pulmonary rehabilitation
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.
• Home-based pulmonary rehabilitation
The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home

Locations

Country	Name	City	State
Turkey	Yedikule Chest Disease Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline distance covered in six-minute walk test at 8 weeks		8 weeks
Primary	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
Primary	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
Primary	Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks		8 weeks