Clinical trial NCT03518177: Comparison of the Effectiveness of Home and Hospital-based PR in Candidate Patients With BLVR
Official title: Comparison of the Effectiveness of Home and Supervised Pulmonary Rehabilitation in Candidate Patients With Bronchoscopic Lung Volume Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Bronchoscopic Lung Volume Reduction
Hospital-based Pulmonary Rehabilitation
Home-based Pulmonary Rehabilitation
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel groups will be formed from patients with hospital-based pulmonary rehabilitation (Group 1) and those with home-based pulmonary rehabilitation(Group 2).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline distance covered in six-minute walk test at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline modified Medical Council Dyspnea score at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline Chronic Obstructive Airway Disease assesment test(CAT) score at 8 weeks
timeFrame: 8 weeks
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Disease Hospital
state: Zeytinburnu
Study officials:
References:
citation: 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.