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Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01772667
First Posted: January 21, 2013
Last Update Posted: November 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
  Purpose
There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. The aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.

Condition Intervention
Idiopathic Pulmonary Fibrosis Procedure: Inpatient Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Long Term Effects of a 3-week Inpatient Pulmonary Rehabilitation Program in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:

Primary Outcome Measures:
  • Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation [ Time Frame: 1 week before rehabilitation to 3 month after finishing rehabilitation ]

Secondary Outcome Measures:
  • Delta of physical activity level from 1 week pre rehabilitation to 3 month post rehabilitation [ Time Frame: 1 week before rehabilitation to 3 month after finishing rehabilitation ]
  • Delta of SF36-score (questionnaire to measure quality of life) from 1 week pre to 3 month post rehabilitation [ Time Frame: 1 week before rehabilitation to 3 month after finishing rehabilitation ]

Estimated Enrollment: 51
Study Start Date: October 2013
Study Completion Date: October 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Usual care during the whole study period without pulmonary rehabilitation. The patients will perform their normal daily life.
Active Comparator: Inpatient Rehabilitation
3-week inpatient multimodal pulmonary rehabilitation program, including daily exercise training, breathing therapy, medical treatment and psychological support. In the following 3 month, the patients will perform their normal daily life.
Procedure: Inpatient Rehabilitation
Rehabilitation program in "Schoen Klinik Berchtesgadener Land"

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • want to start a rehabilitation program in "Schoen Klinik Berchtesgadener Land"
  • patients with idiopathic pulmonary fibrosis (vital capacity > 50% pred.)

Exclusion Criteria:

  • exacerbation in the last 4 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772667


Locations
Germany
Schoen Klinik Berchtesgadener Land
Schoenau am Koenigssee, Bavaria, Germany, 83471
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Investigators
Study Director: Klaus Kenn, MD Head physician in the department of pulmology
  More Information

Responsible Party: Klaus Kenn, Head physician of the Department of Pulmology, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier: NCT01772667     History of Changes
Other Study ID Numbers: Fibrosis2013
First Submitted: January 17, 2013
First Posted: January 21, 2013
Last Update Posted: November 23, 2016
Last Verified: November 2016

Keywords provided by Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken:
pulmonary fibrosis
interstitial lung disease
pulmonary rehabilitation
exercise capacity
physical activity
quality of life

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial