Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

August 21, 2019 updated by: Klaus Kenn, Schön Klinik Berchtesgadener Land

Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schönau am Königssee, Germany, 83471
        • Klinikum Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: interval training
interval training in lung transplant candidates
Other: interval training
at 100 percent of peak Watt
OTHER: Continuous Training
continuous training in lung transplant candidates
Other: continuous endurance training
at 60 percent of peak Watt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Time Frame: value at day 21 minus value at day 1
value at day 21 minus value at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnoea During Exercise Measured on the Borg Scale
Time Frame: mean values from day 1 to day 21

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

  1. Very slight
  2. Slight
  3. Moderate
  4. Somewhat severe
  5. Severe

7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal
mean values from day 1 to day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Investigators

  • Study Director: Klaus Kenn, Dr.med., Klinikum Berchtesgadener Land, Schön-Kliniken

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

August 18, 2009

First Posted (ESTIMATE)

August 19, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRÄ-LTX-08022
  • Ethikkommission
  • Landesärztekammer Bayern
  • Nr. 08022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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