Status and Develepment Mental Quality of Life COPD/IPF In... | NCT03477526

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

NCT03477526

Sponsor

Schön Klinik Berchtesgadener Land

Status

Terminated

Last Update Posted

Nov 13, 2020Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Idiopathic Pulmonary Fibrosis and COPD

Interventions

Pulmonary rehabilitation program

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PhD Student stopped working on this project

Expanded Access Info

Start Date

Feb 26, 2019Actual

Primary Completion Date

Feb 27, 2019Actual

Completion Date

Feb 27, 2019Actual

First Submitted Date

Mar 19, 2018

First Submission Date that Met QC Criteria

Mar 19, 2018

First Posted Date

Mar 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2020

Last Update Posted Date

Nov 13, 2020Actual

Name	Class
Lungenfibrose e.V.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD patients (GOLD stage III-IV)	Experimental		Procedure: Pulmonary rehabilitation program
IPF patients	Active Comparator		Procedure: Pulmonary rehabilitation program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary rehabilitation program	Procedure	3 weeks, ...	COPD patients (GOLD stage III-IV) IPF patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety score	Hospital Anxiety and Depression scale	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Anxiety score	Hospital Anxiety and Depression scale	3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schön Klinik Berchtesgadener Land		Schönau am Königssee		83471	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054990	Idiopathic Pulmonary Fibrosis
D029424	Pulmonary Disease, Chronic Obstructive
D011658	Pulmonary Fibrosis
D001008	Anxiety Disorders
D003863	Depression
D009043	Motor Activity

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive

Browse Leaves

Not provided

Browse Branches

Not provided