Effects of an Inpatient Rehabilitation for Patients With... | NCT01418768

Studies
Effects of an Inpatient Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD) III/IV

NCT01418768

Sponsor

Schön Klinik Berchtesgadener Land

Status

Completed

Last Update Posted

Feb 4, 2013Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

inpatient rehabiliation

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

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Aug 16, 2011

First Posted Date

Aug 17, 2011Estimated

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

Feb 1, 2013

Last Update Posted Date

Feb 4, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Klaus Kenn, Head physician pneumology, Schön Klinik Berchtesgadener LandPrincipal Investigator

Lead Sponsor

Schön Klinik Berchtesgadener LandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to determine if there is a change in the CAT-score after an inpatient rehabilitation of three weeks and if it correlates with other common parameters.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rehabilitation	Experimental		Other: inpatient rehabiliation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
inpatient rehabiliation	Other	inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.	Rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in CAT-score		day 1 to day 21

Secondary Outcomes

Measure	Description	Time Frame
Change in 6 minutes walking distance		day 1 to day 21
Change in Short-Form 36		day 1 to day 21
Change in Hospital Anxiety and Depression Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

inpatient rehabilitation in Schön Klinik Berchtesgadener Land
stable COPD(GOLD severity III and IV with and without respiratory insufficiency)

Exclusion Criteria:

severe exacerbation in the last four weeks
acute coronary syndrome
unability to cooperate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

75 Years

Standard Ages

ChildAdultOlder 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

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided