Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT00962078
First received: July 27, 2009
Last updated: November 10, 2011
Last verified: November 2011

July 27, 2009
November 10, 2011
July 2008
October 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962078 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • COPD
  • Pre-Lung-Transplantation
  • Hypercapnia
  • Respiratory Insufficiency
  • Other: continuous endurance training
    at 60 percent of peak Watt
  • Other: interval training
    at 100 percent of peak Watt
  • interval training
    interval training in lung transplant candidates
    Intervention: Other: interval training
  • Continuous Training
    continuous training in lung transplant candidates
    Intervention: Other: continuous endurance training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00962078
PRÄ-LTX-08022, Ethikkommission, Landesärztekammer Bayern, Nr. 08022
No
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
Klinikum Berchtesgadener Land der Schön-Kliniken
Not Provided
Study Director: Klaus Kenn, Dr.med. Klinikum Berchtesgadener Land, Schön-Kliniken
Klinikum Berchtesgadener Land der Schön-Kliniken
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP