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

Not Applicable

Completed

• Conditions: Home-based Pulmonary Rehabilitation; Emphysema; Bronchoscopic Lung Volume Reduction; Hospital-based Pulmonary Rehabilitation
• Interventions: Other: Hospital-based pulmonary rehabilitation; Other: Home-based pulmonary rehabilitation

• Registration Number: NCT03518177
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-05-08
• Study Start: 2018-05-15
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital-based PR group	Hospital-based pulmonary rehabilitation	The patient will receive an 8-week supervised Pulmonary Rehabilitation Exercise Program at hospital
Home-based PR group	Home-based pulmonary rehabilitation	The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program at home

Primary Outcome Measures

Name	Time	Method
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	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.
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks	8 weeks
Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 8 weeks	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.

Trial Locations

Locations (1)

Yedikule Chest Disease Hospital; 🇹🇷 Istanbul, Zeytinburnu, Turkey