NCT01418768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 4, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

August 9, 2011

Last Update Submit

February 1, 2013

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDCATRehabilitationchronic obstructive pulmonary disease GOLD III/IV

Outcome Measures

Primary Outcomes (1)

  • Change in CAT-score

    day 1 to day 21

Secondary Outcomes (9)

  • 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

    day 1 to day 21

  • Change in diffusing capacity

    day 1 to day 21

  • Change in forced expiratory volume in 1 second (FEV1)

    day 1 to day 21

  • +4 more secondary outcomes

Study Arms (1)

Rehabilitation

EXPERIMENTAL
Other: inpatient rehabiliation

Interventions

inpatient rehabiliationOTHER

inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.

Rehabilitation

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head physician pneumology

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 17, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

February 4, 2013

Record last verified: 2013-02

Locations

DE(1)