Trial record 7 of 98 for:    Open Studies | "Pulmonary Fibrosis"

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014