Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
Primary Purpose
COPD, Pre-Lung-Transplantation, Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
continuous endurance training
interval training
Sponsored by
About this trial
This is an interventional treatment trial for COPD focused on measuring COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD
Eligibility 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
Sites / Locations
- Klinikum Berchtesgadener Land
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
interval training
Continuous Training
Arm Description
interval training in lung transplant candidates
continuous training in lung transplant candidates
Outcomes
Primary Outcome Measures
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00962078
First Posted
July 27, 2009
Last Updated
August 21, 2019
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT00962078
Brief Title
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
Official Title
Effects of a Complex Pulmonary Rehabilitation Program on Patients With End Stage Lung Diseases Undergoing Evaluation for Lung Transplantation (Pre-LTx)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Pre-Lung-Transplantation, Hypercapnia, Respiratory Insufficiency
Keywords
COPD, Pre-Lung-Transplantation, Intervall versus continuous training, 6 MWD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
interval training
Arm Type
Other
Arm Description
interval training in lung transplant candidates
Arm Title
Continuous Training
Arm Type
Other
Arm Description
continuous training in lung transplant candidates
Intervention Type
Other
Intervention Name(s)
continuous endurance training
Intervention Description
at 60 percent of peak Watt
Intervention Type
Other
Intervention Name(s)
interval training
Intervention Description
at 100 percent of peak Watt
Primary Outcome Measure Information:
Title
Effects of a Multimodal Pulmonary Rehabilitation Program on 6 Minute Walking Distance (6MWD)
Time Frame
value at day 21 minus value at day 1
Secondary Outcome Measure Information:
Title
Dyspnoea During Exercise Measured on the Borg Scale
Description
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
Time Frame
mean values from day 1 to day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, Dr.med.
Organizational Affiliation
Klinikum Berchtesgadener Land, Schön-Kliniken
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum Berchtesgadener Land
City
Schönau am Königssee
ZIP/Postal Code
83471
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)
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