Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

Not Applicable

Completed

• Conditions: COPD; Pre-Lung-Transplantation; Hypercapnia; Respiratory Insufficiency
• Interventions: Other: continuous endurance training; Other: interval training

• Registration Number: NCT00962078
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-07-27
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2019-03-06
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-21
• Last Update Submitted: 2019-08-21
• Results First Posted: 2019-09-23
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Training	continuous endurance training	continuous training in lung transplant candidates
interval training	interval training	interval training in lung transplant candidates

Primary Outcome Measures

Name	Time	Method
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)	value at day 21 minus value at day 1

Secondary Outcome Measures

Name	Time	Method
Dyspnoea During Exercise Measured on the Borg Scale	mean values from day 1 to day 21	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; 1. Very slight; 2. Slight; 3. Moderate; 4. Somewhat severe; 5. Severe; 7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal

Trial Locations

Locations (1)

Klinikum Berchtesgadener Land; 🇩🇪 Schönau am Königssee, Germany