NCT02708719

Brief Summary

The purpose of this study is to determine the minimal important difference (MID) for the 1-minute-sit-to-stand-test (STST) with an anchor-based method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

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

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

March 10, 2016

Last Update Submit

February 14, 2018

Conditions

COPD

Keywords

COPDMID1-minute sit-to-stand-test

Outcome Measures

Primary Outcomes (1)

  • MID of the 1-minute-STST

    Change of maximum 1-minute sit-to-stand repititions

    21 days

Secondary Outcomes (2)

  • 6-minute-walk distance

    21 days

  • CRQ Score

    21 days

Study Arms (1)

Pulmonary rehabilitation

OTHER

multimodal pulmonary Rehabilitation program (3 weeks Duration)

Procedure: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationPROCEDURE

Inpatient pulmonary rehabilitation has a duration of 3 weeks. This multimodal program consists of exercise training, breathing therapy, medical council, education and psychological support.

Pulmonary rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Patients with COPD (GOLD-Stage II to IV)
  • Ability to stand-up and walk
  • written informed consent

You may not qualify if:

  • orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training
  • acute exacerbation
  • heart failure, acute coronary syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berchtesgardener Land

Schönau am Königssee, Bavaria, 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 Officials

  • Klaus Kenn, Prof. Dr.

    Schoen Klinik BGL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Klaus Kenn

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 15, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 15, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)