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Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

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ClinicalTrials.gov Identifier: NCT00962078
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : November 11, 2011
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken

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.

Condition or disease Intervention/treatment Phase
COPD Pre-Lung-Transplantation Hypercapnia Respiratory Insufficiency Other: continuous endurance training Other: interval training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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)
Study Start Date : July 2008
Actual Primary Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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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

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

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 Posted: August 19, 2009    Key Record Dates
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