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

This study is currently recruiting participants.
Verified October 2013 by Klinikum Berchtesgadener Land der Schön-Kliniken
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Klinikum Berchtesgadener Land der Schön-Kliniken
ClinicalTrials.gov Identifier:
NCT01772667
First received: January 17, 2013
Last updated: October 30, 2013
Last verified: October 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 51
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772667

Contacts
Contact: Klaus Kenn, MD 0049865293 ext 1630 kkenn@schoen-kliniken.de

Locations
Germany
Schoen Klinik Berchtesgadener Land Recruiting
Schoenau am Koenigssee, Bavaria, Germany, 83471
Contact: Klaus Kenn, MD    +49 8652 931541    kkenn@schoen-kliniken.de   
Sponsors and Collaborators
Klinikum Berchtesgadener Land der Schön-Kliniken
Investigators
Study Director: Klaus Kenn, MD Head physician in the department of pulmology
  More Information

No publications provided

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
Study First Received: January 17, 2013
Last Updated: October 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by 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
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on April 15, 2014