COPDNCT02708719
Development of a MID for the 1-minute Sit-to-stand Test
A study testing Pulmonary rehabilitation in people with COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with COPD (GOLD-Stage II to IV)
- Ability to stand-up and walk
- written informed consent
Who cannot join
- orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training
- acute exacerbation
- heart failure, acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Minimal Important Difference 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.
Read the 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.
- Conditions
- COPD
- Being tested
- Pulmonary rehabilitation
- Keywords
- COPD, MID, 1-minute sit-to-stand-test
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationProcedure or surgery
Inpatient pulmonary rehabilitation has a duration of 3 weeks. This multimodal program consists of exercise training, breathing therapy, medical council, education and psychological support.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Other | multimodal pulmonary Rehabilitation program (3 weeks Duration) Receives: Procedure: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MID of the 1-minute-STST
Change of maximum 1-minute sit-to-stand repititions
Measured: 21 days
Secondary outcomes (2)
6-minute-walk distance
Maximal walk distance reached in 6 minutes
Measured: 21 days
CRQ Score
CRQ is a health-related Quality of life questionnaire
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof. Dr., Principal investigator, Schoen Klinik BGL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708719
- Sponsor's protocol ID
- MID 1-minute STST
- Status last verified
- Feb 2018
- First submitted
- 10 Mar 2016
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Minimal Important Difference for the 1-minute Sit-to-stand Test
- ClinicalTrials.gov ID
- NCT02708719
- Acronym / sponsor ID
- MID 1-minute STST
- Conditions
- COPD
- Keywords
- COPD, MID, 1-minute sit-to-stand-test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Other | Procedure: Pulmonary rehabilitationmultimodal pulmonary Rehabilitation program (3 weeks Duration) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with COPD (GOLD-Stage II to IV)
- Ability to stand-up and walk
- written informed consent
Key exclusion criteria (3 listed)
- orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training
- acute exacerbation
- heart failure, acute coronary syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationInpatient pulmonary rehabilitation has a duration of 3 weeks. This multimodal program consists of exercise training, breathing therapy, medical council, education and psychological support. | Procedure or surgery | Pulmonary rehabilitation |
Primary outcome
MID of the 1-minute-STST
Time frame: 21 days
Change of maximum 1-minute sit-to-stand repititions
2 secondary outcomes
6-minute-walk distance
Time frame: 21 days
CRQ Score
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Prof. Dr. principal investigator
Schoen Klinik BGL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MID of the 1-minute-STST (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.