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

NCT ID: NCT02708719

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulmonary rehabilitation

multimodal pulmonary Rehabilitation program (3 weeks Duration)

Group Type OTHER

Pulmonary rehabilitation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Klaus Kenn

Prof. Dr. Klaus Kenn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Klaus Kenn, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Schoen Klinik BGL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Berchtesgardener Land

Schönau am Königssee, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MID 1-minute STST

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Real-Time Support for Exercise Persistence in COPD
NCT00373932 COMPLETED PHASE1/PHASE2