We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962078
First Posted: August 19, 2009
Last Update Posted: November 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
  Purpose
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.

Condition Intervention
COPD Pre-Lung-Transplantation Hypercapnia Respiratory Insufficiency Other: continuous endurance training Other: interval training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)

Resource links provided by NLM:


Further study details as provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • Effects of a multimodal pulmonary rehabilitation program on physical activity measured via 6 minute walking distance(6MWD) [ Time Frame: day 1, day 14 and day 21 ]

Secondary Outcome Measures:
  • Dyspnoea; Health Related Quality of Life (HRQL) in pre-LTx-Patients; PaCO2-behavior during training; Comparison of CT- and IT-Methode; Prevalence of anxiety and depression (HADS) in patients with end stage lung disease undergoing rehabilitation [ Time Frame: day 1, day 14 and day 21 ]

Enrollment: 60
Study Start Date: July 2008
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
interval training
interval training in lung transplant candidates
Other: interval training
at 100 percent of peak Watt
Continuous Training
continuous training in lung transplant candidates
Other: continuous endurance training
at 60 percent of peak Watt

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962078


Locations
Germany
Klinikum Berchtesgadener Land
Schönau am Königssee, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Investigators
Study Director: Klaus Kenn, Dr.med. Klinikum Berchtesgadener Land, Schön-Kliniken
  More Information

Responsible Party: Klaus Kenn, Dr, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT00962078     History of Changes
Other Study ID Numbers: PRÄ-LTX-08022
Ethikkommission
Landesärztekammer Bayern
Nr. 08022
First Submitted: July 27, 2009
First Posted: August 19, 2009
Last Update Posted: November 11, 2011
Last Verified: November 2011

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
COPD
Pre-Lung-Transplantation
Intervall versus continuous training
6 MWD

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms