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CompletedNCT03518177Updated Mar 8, 2019

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

An interventional study of Hospital-based pulmonary rehabilitation and Home-based pulmonary rehabilitation in Emphysema, Bronchoscopic Lung Volume Reduction and Hospital-based Pulmonary Rehabilitation, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-08.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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03

In context

Emphysema

339 studies on the registry are indexed under Emphysema; 59 are open to participants now.

This study's enrollment of 66 is above the median of 48 across 208 interventional studies indexed under Emphysema.

Browse Emphysema studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 365 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    Hospital-based PR group

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

    Other: Hospital-based pulmonary rehabilitation

  • Experimental
    Home-based PR group

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

    Other: Home-based pulmonary rehabilitation

Interventions

  • OtherHospital-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.

  • OtherHome-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

06

What researchers measure

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

    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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Yedikule Chest Disease Hospital
    Istanbul, Zeytinburnu 34200, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 32709500 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Nov 2018, 5 months.

Of 39 non-industry interventional studies with no phase under Emphysema, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 59. This study's 5 months is below that.

Counting every sponsor, half of 61 studies reached it within 37 months; a quarter within 25 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 25, 2018
First posted
May 8, 2018
StartActual
May 15, 2018
Primary completionActual
Nov 1, 2018
CompletionActual
Dec 1, 2018
Last update
Mar 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03518177
Responsible party
esra pehlivan (Principal Investigator, Istanbul Medipol University Hospital) — Principal investigator
First posted
May 8, 2018
Start date
May 15, 2018
Primary completion
Nov 1, 2018
Completion
Dec 1, 2018
Last update
Mar 8, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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