Pulmonary Disease, Chronic ObstructiveSTAND-UPNCT02441725
Validation of the 1-minute Sit-to-stand Test in Patients With COPD
A study testing 1-minute sit-to-stand test in people with Pulmonary Disease, Chronic Obstructive, run by University of Zurich at 1 site in Switzerland.
Trial summary
This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- 1-minute sit-to-stand test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to May 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis according to GOLD criteria; post bronchodilator FEV1/FVC<70%
- Male and female patients ≥40 years of age
- Able to do at least 5 repetitions in the 1-min STS test at baseline assessment
- Written informed consent by the participant
Who cannot join
- Lower limb joint surgery in the preceding 3 months
- Too unstable medically to perform exercise tests
- Predominant neurological or musculoskeletal limitation to walking
- Cognitive reading impairment and/or difficulties managing the eDiary and step-counter
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1-minute Sit-to-stand Test: A Multicentre Validation Study of a Simple Exercise Capacity Test in Patients With Chronic Obstructive Pulmonary Disease
This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires.
Read the detailed description
Exercise capacity is a strong predictor for mortality, exacerbations and health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD). The 1-minute sit-to-stand test (1-min STS test) is a promising exercise capacity test that is simple to conduct and requires few resources.
This study will provide an in-depth validation of the 1-min STS test, specifically evaluating the tests reliability, validity, responsiveness to change and minimal clinically important difference. The study will also assess the predictive properties of the 1-min STS test with regards to detecting exacerbations, as well as identify patterns of physical activity and patient-reported symptoms of exacerbations.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- 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.
1-minute sit-to-stand testOther
Validation of the 1-minute sit-to-stand test in a COPD patient population
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation Patients | Other | Validation of the 1-minute sit-to-stand test; for participants who consent including a extended daily assessment period of physical activity and patient-reported symptoms of exacerbations:
Male and female COPD inpatients (≥40 years of age) from two pulmonary rehabilitation clinics (Klinik Barmelweid and Zürcher Höhenklinik Wald) Receives: Other: 1-minute sit-to-stand test |
| Acute Care Hospital Patients | Other | Validation of the 1-minute sit-to-stand test, including daily assessment of physical activity and patient-reported symptoms of exacerbations:
Male and female COPD inpatients from two acute care hospitals (≥40 years of age; Stadtspital Waid and Spital Uster) Receives: Other: 1-minute sit-to-stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-minute sit-to-stand test
Number of repetitions performed in the 1-minute sit-to-stand test
Measured: Change from baseline after pulmonary rehabilitation programme
Secondary outcomes (17)
5-repetition sit-to-stand test
Time taken to perform 5 sit-to-stand repetitions
Measured: Change from baseline after pulmonary rehabilitation programme
6-minute walk test
Distance walked in 6 minutes
Measured: Change from baseline after pulmonary rehabilitation programme
Quadriceps maximal voluntary contraction force
Measured: Change from baseline after pulmonary rehabilitation programme
Chronic Respiratory Questionnaire
Measured: Change from baseline after pulmonary rehabilitation programme
Hospital Anxiety and Depression Scale
Measured: Change from baseline after pulmonary rehabilitation programme
COPD Assessment Test
Measured: Change from Baseline after pulmonary rehabilitation programme
Baseline Dyspnoea & Transition Dyspnoea Index
Measured: Change from baseline after pulmonary rehabilitation programme
Feeling Thermometer
Measured: Change from baseline after pulmonary rehabilitation programme
Oxygen consumption (VO2)
Measured: Change from baseline (pre-exercise test) during and after test
Carbon dioxide production (VCO2)
Measured: Change from baseline (pre-exercise test) during and after test
Respiratory exchange ratio (RER)
Measured: Change from baseline (pre-exercise test) during and after test
Minute ventilation (VE)
Measured: Change from baseline (pre-exercise test) during and after test
Heart Rate
Measured: Change from baseline (pre-exercise test) during and after test
Blood oxygen saturation
Measured: Change from baseline (pre-exercise test) during and after test
Symptoms of exacerbations
The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)
Measured: Daily course over 3 months
Physical activity
As measured by a pedometer
Measured: Daily course over 3 months
Localisation
As measured by GPS information
Measured: Daily course over 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja Frei, pHd, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441725
- Sponsor's protocol ID
- STAND-UP Study
- Acronym
- STAND-UP
- Status last verified
- Oct 2016
- First submitted
- 29 Apr 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1-minute Sit-to-stand Test: A Multicentre Validation Study of a Simple Exercise Capacity Test in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02441725
- Acronym / sponsor ID
- STAND-UP / STAND-UP Study
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 May 2015 (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.
This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires.
Detailed description
Exercise capacity is a strong predictor for mortality, exacerbations and health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD). The 1-minute sit-to-stand test (1-min STS test) is a promising exercise capacity test that is simple to conduct and requires few resources.
This study will provide an in-depth validation of the 1-min STS test, specifically evaluating the tests reliability, validity, responsiveness to change and minimal clinically important difference. The study will also assess the predictive properties of the 1-min STS test with regards to detecting exacerbations, as well as identify patterns of physical activity and patient-reported symptoms of exacerbations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation Patients | Other | Other: 1-minute sit-to-stand testValidation of the 1-minute sit-to-stand test; for participants who consent including a extended daily assessment period of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients (≥40 years of age) from two pulmonary rehabilitation clinics (Klinik Barmelweid and Zürcher Höhenklinik Wald) |
| Acute Care Hospital Patients | Other | Other: 1-minute sit-to-stand testValidation of the 1-minute sit-to-stand test, including daily assessment of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients from two acute care hospitals (≥40 years of age; Stadtspital Waid and Spital Uster) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD diagnosis according to GOLD criteria; post bronchodilator FEV1/FVC<70%
- Male and female patients ≥40 years of age
- Able to do at least 5 repetitions in the 1-min STS test at baseline assessment
- Written informed consent by the participant
Key exclusion criteria (4 listed)
- Lower limb joint surgery in the preceding 3 months
- Too unstable medically to perform exercise tests
- Predominant neurological or musculoskeletal limitation to walking
- Cognitive reading impairment and/or difficulties managing the eDiary and step-counter
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 |
|---|---|---|
| 1-minute sit-to-stand testValidation of the 1-minute sit-to-stand test in a COPD patient population | Other | Acute Care Hospital Patients, Pulmonary Rehabilitation Patients |
Primary outcome
1-minute sit-to-stand test
Time frame: Change from baseline after pulmonary rehabilitation programme
Number of repetitions performed in the 1-minute sit-to-stand test
17 secondary outcomes
5-repetition sit-to-stand test
Time frame: Change from baseline after pulmonary rehabilitation programme
6-minute walk test
Time frame: Change from baseline after pulmonary rehabilitation programme
Quadriceps maximal voluntary contraction force
Time frame: Change from baseline after pulmonary rehabilitation programme
Chronic Respiratory Questionnaire
Time frame: Change from baseline after pulmonary rehabilitation programme
Hospital Anxiety and Depression Scale
Time frame: Change from baseline after pulmonary rehabilitation programme
COPD Assessment Test
Time frame: Change from Baseline after pulmonary rehabilitation programme
Baseline Dyspnoea & Transition Dyspnoea Index
Time frame: Change from baseline after pulmonary rehabilitation programme
Feeling Thermometer
Time frame: Change from baseline after pulmonary rehabilitation programme
Oxygen consumption (VO2)
Time frame: Change from baseline (pre-exercise test) during and after test
Carbon dioxide production (VCO2)
Time frame: Change from baseline (pre-exercise test) during and after test
Respiratory exchange ratio (RER)
Time frame: Change from baseline (pre-exercise test) during and after test
Minute ventilation (VE)
Time frame: Change from baseline (pre-exercise test) during and after test
Heart Rate
Time frame: Change from baseline (pre-exercise test) during and after test
Blood oxygen saturation
Time frame: Change from baseline (pre-exercise test) during and after test
Symptoms of exacerbations
Time frame: Daily course over 3 months
Physical activity
Time frame: Daily course over 3 months
Localisation
Time frame: Daily course over 3 months
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 25 Oct 2016.
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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.
Anja Frei, pHd principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-minute sit-to-stand test in people with Pulmonary Disease, Chronic Obstructive, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 4 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 25 Oct 2016. 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 Switzerland. 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?
1-minute sit-to-stand test (time frame: Change from baseline after pulmonary rehabilitation programme). 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 25 Oct 2016.