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Completed

NCT Number: NCT02708719

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berchtesgardener Land

Schönau am Königssee, Bavaria, 83471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary rehabilitation

Procedure

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

Primary outcomes

  1. MID of the 1-minute-STST

    Time frame: 21 days

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

Secondary outcomes

  1. 6-minute-walk distance

    Time frame: 21 days

    Maximal walk distance reached in 6 minutes

  2. CRQ Score

    Time frame: 21 days

    CRQ is a health-related Quality of life questionnaire

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2016
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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