Pulmonary Rehabilitation in Patients Before Lung Transplantation (LTx)

NCT ID: NCT00962078

Last Updated: 2019-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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COPD Pre-Lung-Transplantation Hypercapnia Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interval training

interval training in lung transplant candidates

Group Type OTHER

interval training

Intervention Type OTHER

at 100 percent of peak Watt

Continuous Training

continuous training in lung transplant candidates

Group Type OTHER

continuous endurance training

Intervention Type OTHER

at 60 percent of peak Watt

Interventions

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continuous endurance training

at 60 percent of peak Watt

Intervention Type OTHER

interval training

at 100 percent of peak Watt

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Klaus Kenn, Dr.med.

Role: STUDY_DIRECTOR

Klinikum Berchtesgadener Land, Schön-Kliniken

Locations

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Klinikum Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Ethikkommission

Identifier Type: -

Identifier Source: secondary_id

Landesärztekammer Bayern

Identifier Type: -

Identifier Source: secondary_id

Nr. 08022

Identifier Type: -

Identifier Source: secondary_id

PRÄ-LTX-08022

Identifier Type: -

Identifier Source: org_study_id

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