Back to resultsLong Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Inpatient Rehabilitation
Sponsored by
About this trial
This is an interventional health services research trial for Idiopathic Pulmonary Fibrosis focused on measuring pulmonary fibrosis, interstitial lung disease, pulmonary rehabilitation, exercise capacity, physical activity, quality of life
Eligibility 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
Sites / Locations
- Schoen Klinik Berchtesgadener Land
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual care
Inpatient Rehabilitation
Arm Description
Usual care during the whole study period without pulmonary rehabilitation. The patients will perform their normal daily life.
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.
Outcomes
Primary Outcome Measures
Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation
Secondary Outcome Measures
Delta of physical activity level from 1 week pre rehabilitation to 3 month post rehabilitation
Delta of SF36-score (questionnaire to measure quality of life) from 1 week pre to 3 month post rehabilitation
Full Information
NCT ID
NCT01772667
First Posted
January 17, 2013
Last Updated
September 2, 2020
Sponsor
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT01772667
Brief Title
Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
Official Title
Long Term Effects of a 3-week Inpatient Pulmonary Rehabilitation Program in Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
pulmonary fibrosis, interstitial lung disease, pulmonary rehabilitation, exercise capacity, physical activity, quality of life
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care during the whole study period without pulmonary rehabilitation. The patients will perform their normal daily life.
Arm Title
Inpatient Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Inpatient Rehabilitation
Intervention Description
Rehabilitation program in "Schoen Klinik Berchtesgadener Land"
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kenn, MD
Organizational Affiliation
Head physician in the department of pulmology
Official's Role
Study Director
Facility Information:
Facility Name
Schoen Klinik Berchtesgadener Land
City
Schoenau Am Koenigssee
State/Province
Bavaria
ZIP/Postal Code
83471
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
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