Development of a MID for the 1-minute Sit-to-stand Test

COPD Clinical Trial

Official title:

Development of a Minimal Important Difference for the 1-minute Sit-to-stand Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708719
• Other study ID #: MID 1-minute STST
• Status: Completed
• Phase: N/A
• First received: March 10, 2016
• Last updated: February 14, 2018
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Klinikum Berchtesgadener Land der Schön-Kliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In this study we develop the minimal important difference for the 1-minute sit-to-stand-test (STST) with an anchor-based method.

First step of this study is to find out the differences in the number of repetitions during 1-minute STST, 6-minute walk distance and health-related quality of life from pre to post inpatient pulmonary Rehabilitation program (3 weeks Duration) in the Schoen-Klinik Berchtesgadener Land.

In Addition, Balance tests on the Leonardo-Mechanograph will be performed and the Hospital Anxiety and Depression Scale (HADS) and Chronic Respiratory Questionnaire (CRQ) will be assessed.

For the second step we will use an anchor-based approach to estimate the MID of the STST. 6MWD and CRQ are used as anchors for which the MID has been established before.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with COPD (GOLD-Stage II to IV)

• Ability to stand-up and walk

• written informed consent

Exclusion Criteria:

• orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training

• acute exacerbation

• heart failure, acute coronary syndrome

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
Germany	Berchtesgardener Land	Schönau am Königssee	Bayern

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken	AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MID of the 1-minute-STST	Change of maximum 1-minute sit-to-stand repititions	21 days
Secondary	6-minute-walk distance	Maximal walk distance reached in 6 minutes	21 days
Secondary	CRQ Score	CRQ is a health-related Quality of life questionnaire	21 days