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Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation

Primary Purpose

Idiopathic Pulmonary Fibrosis and COPD

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pulmonary rehabilitation program
Sponsored by
Schön Klinik Berchtesgadener Land
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Idiopathic Pulmonary Fibrosis and COPD focused on measuring pulmonary fibrosis, COPD, pulmonary rehabilitation, mental status (anxiety and depression), quality of life, physical activity

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • COPD GOLD III-IV
  • IPF according Pulmonary Guidelines

Exclusion Criteria:

< 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient

Sites / Locations

  • Schön Klinik Berchtesgadener Land

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COPD patients (GOLD stage III-IV)

IPF patients

Arm Description

Outcomes

Primary Outcome Measures

Anxiety score
Hospital Anxiety and Depression scale

Secondary Outcome Measures

Anxiety score
Hospital Anxiety and Depression scale

Full Information

First Posted
March 19, 2018
Last Updated
November 10, 2020
Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Lungenfibrose e.V.
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1. Study Identification

Unique Protocol Identification Number
NCT03477526
Brief Title
Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation
Official Title
Status and Develepment Mental Quality of Life in Lung Fibrosis in Comparison of COPD Inpatients Before and After Pulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
PhD Student stopped working on this project
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Lungenfibrose e.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis and COPD
Keywords
pulmonary fibrosis, COPD, pulmonary rehabilitation, mental status (anxiety and depression), quality of life, physical activity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD patients (GOLD stage III-IV)
Arm Type
Experimental
Arm Title
IPF patients
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation program
Intervention Description
3 weeks, ...
Primary Outcome Measure Information:
Title
Anxiety score
Description
Hospital Anxiety and Depression scale
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Anxiety score
Description
Hospital Anxiety and Depression scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD GOLD III-IV IPF according Pulmonary Guidelines Exclusion Criteria: < 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau a.Königssee
ZIP/Postal Code
83471
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation

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