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Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

Primary Purpose

COPD, Pre-Lung-Transplantation, Hypercapnia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
continuous endurance training
interval training
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pre-LTx (listed for lung-transplantation or currently undergoing evaluation)
  • COPD Stadium IV GOLD
  • α-1-Antitrypsin-deficiency-Emphysema
  • respiratory Insufficiency
  • oxygen therapy (LTOT)

Exclusion Criteria:

  • serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation
  • clinical signs of manifest heart insufficiency
  • acute coronar syndrome
  • left heart insufficiency(EF < 40%)
  • missing Compliance

Sites / Locations

  • Klinikum Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

interval training

Continuous Training

Arm Description

interval training in lung transplant candidates

continuous training in lung transplant candidates

Outcomes

Primary Outcome Measures

Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)

Secondary Outcome Measures

Dyspnoea During Exercise Measured on the Borg Scale
The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea. The scale is like follows: 0 Nothing at all Very slight Slight Moderate Somewhat severe Severe 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal

Full Information

First Posted
July 27, 2009
Last Updated
August 21, 2019
Sponsor
Schön Klinik Berchtesgadener Land
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1. Study Identification

Unique Protocol Identification Number
NCT00962078
Brief Title
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
Official Title
Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to study the effects of a complex pulmonary rehabilitation program on mobility measured by 6 minute walking distance (6MWD) and physical activity, measured via Dynaport and Actibelt Aktivitätsmonitor, dyspnoea (VAS), quality of life (HRQL (SF36, EuroQul)), anxiety and depression (HADS)and PaCO2-behavior under physical activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pre-Lung-Transplantation, Hypercapnia, Respiratory Insufficiency
Keywords
COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interval training
Arm Type
Other
Arm Description
interval training in lung transplant candidates
Arm Title
Continuous Training
Arm Type
Other
Arm Description
continuous training in lung transplant candidates
Intervention Type
Other
Intervention Name(s)
continuous endurance training
Intervention Description
at 60 percent of peak Watt
Intervention Type
Other
Intervention Name(s)
interval training
Intervention Description
at 100 percent of peak Watt
Primary Outcome Measure Information:
Title
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Time Frame
value at day 21 minus value at day 1
Secondary Outcome Measure Information:
Title
Dyspnoea During Exercise Measured on the Borg Scale
Description
The Borg scale is a numeric scale that ranges from 0 to 10 points to rate dyspnea. The scale is like follows: 0 Nothing at all Very slight Slight Moderate Somewhat severe Severe 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal
Time Frame
mean values from day 1 to day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pre-LTx (listed for lung-transplantation or currently undergoing evaluation) COPD Stadium IV GOLD α-1-Antitrypsin-deficiency-Emphysema respiratory Insufficiency oxygen therapy (LTOT) Exclusion Criteria: serious Exacerbation (Symptoms longer than three days, change of therapy, e.i. antibiotics, steroids) during the last four weeks before rehabilitation clinical signs of manifest heart insufficiency acute coronar syndrome left heart insufficiency(EF < 40%) missing Compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr.med.
Organizational Affiliation
Klinikum Berchtesgadener Land, Schön-Kliniken
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

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