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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 27, 2009
Last Updated: November 10, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Hypercapnia
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Signs and Symptoms, Respiratory
Signs and Symptoms
 Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 21, 2013