Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962078
• Other study ID #: PRÄ-LTX-08022
• Secondary ID: EthikkommissionL
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2019
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• pre-LTx (listed for lung-transplantation or currently undergoing evaluation)

• COPD Stadium IV GOLD

• a-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

Related Conditions & MeSH terms

• COPD
• Hypercapnia
• Pre-Lung-Transplantation
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Other:
• continuous endurance training
at 60 percent of peak Watt
• interval training
at 100 percent of peak Watt

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land	Schönau am Königssee

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)		value at day 21 minus value at day 1
Secondary	Dyspnoea During Exercise Measured on the Borg Scale	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; Very slight; Slight; Moderate; Somewhat severe; Severe; 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal	mean values from day 1 to day 21