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

Not Applicable

Completed

• Conditions: COPD
• Interventions: Procedure: Pulmonary rehabilitation

• Registration Number: NCT02708719
• Lead Sponsor: Schön Klinik Berchtesgadener Land

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-10
• Study First Posted: 2016-03-15
• Study Start: 2016-04
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary rehabilitation	Pulmonary rehabilitation	multimodal pulmonary Rehabilitation program (3 weeks Duration)

Primary Outcome Measures

Name	Time	Method
MID of the 1-minute-STST	21 days	Change of maximum 1-minute sit-to-stand repititions

Secondary Outcome Measures

Name	Time	Method
6-minute-walk distance	21 days	Maximal walk distance reached in 6 minutes
CRQ Score	21 days	CRQ is a health-related Quality of life questionnaire

Trial Locations

Locations (1)

Berchtesgardener Land; 🇩🇪 Schönau am Königssee, Bayern, Germany