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Completed

NCT Number: NCT00962078

Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Hypercapnia Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Lung-Transplantation Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Endurance Training

Other

at 60 percent of peak Watt

Interval training

Other

at 100 percent of peak Watt

Primary outcomes

  1. 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 outcomes

  1. Dyspnoea During Exercise Measured on the Borg Scale

    Time frame: 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

    • Very slight
    • Slight
    • Moderate
    • Somewhat severe
    • Severe

    7 Very severe 8 9 Very, very severe (almost maximal) 10 Maximal

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 19, 2009
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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