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OpenTrials
Completed

NCT Number: NCT03518177

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

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.

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Key information

Conditions

Emphysema Bronchoscopic Lung Volume Reduction Home-based Pulmonary Rehabilitation Hospital-based Pulmonary Rehabilitation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hospital-based pulmonary rehabilitation

Other

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

Other

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

Primary outcomes

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

    Time frame: 8 weeks

  2. Change from baseline modified Medical Council Dyspnea score at 8 weeks

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 8, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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