NCT04159129

Brief Summary

The aim of this study is to evaluate the effects of a three-week inpatient pulmonary rehabilitation (PR) program on the walking speed in patients with chronic obstructive (COPD) or interstitial lung disease (ILD).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

November 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 7, 2019

Last Update Submit

November 20, 2019

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, Interstitial

Keywords

walking speeddyspnoestressanxietytraffic light

Outcome Measures

Primary Outcomes (1)

  • change of maximum walking speed

    assessed during a walk of 11m

    Day 1 and Day 21

Secondary Outcomes (11)

  • Change of usual walking Speed

    Day 1 and Day 21

  • Change in balance

    Day 1 and Day 21

  • Change in walking speed during a field walk test

    Day 1 and Day 21

  • Change in tension symptoms during a field walk test

    Day 1 and Day 21

  • Change of exercise capacity

    Day 1 and Day 21

  • +6 more secondary outcomes

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with COPD or ILD who fulfill the inclusion criteria will be recruited during an inpatient pulmonary Rehabilitation program.

You may qualify if:

  • Participation in a pulmonary Rehabilitation program (Schön Klinik BGL)
  • Indication: COPD or ILD
  • COPD; FEV1 \<50%
  • ILD: FVC \<70%
  • written informed consent

You may not qualify if:

  • non compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schön Klinikum Berchtesgadener Land

Schönau am Königssee, Bavaria, 83471, Germany

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung Diseases, InterstitialAnxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Klaus Kenn, Prof.

    Schön Klinik Berchtesgadener Land

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus Kenn, Prof.

CONTACT

0049865293kkenn@schoen-klinik.de

Inga Jarosch, PhD

CONTACT

0049865293ijarosch@schoen-klinik.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Klaus Kenn

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 12, 2019

Study Start

November 7, 2019

Primary Completion

April 30, 2020

Study Completion

July 31, 2020

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)