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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02708719
Enrollment
105
Registered
2016-03-15
Start date
2016-04-30
Completion date
2017-12-31
Last updated
2018-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, MID, 1-minute sit-to-stand-test

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.

Interventions

PROCEDUREPulmonary 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.

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Schön Klinik Berchtesgadener Land
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MID of the 1-minute-STST21 daysChange of maximum 1-minute sit-to-stand repititions

Secondary

MeasureTime frameDescription
6-minute-walk distance21 daysMaximal walk distance reached in 6 minutes
CRQ Score21 daysCRQ is a health-related Quality of life questionnaire

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026