Chronic Obstructive Pulmonary DiseaseNCT02631434
Comparison Between Sit-to-stand Test and Six-minute Walk Test in Chronic Obstructive Pulmonary Disease
A study testing sit-to-stand test and six-minutes walking test in people with Chronic Obstructive Pulmonary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- sit-to-stand test and six-minutes walking test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to Aug 2013
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically stable for a minimum of 4 weeks
- no recent infectious exacerbations
Who cannot join
- musculoskeletal or joint disorders
- contra-indications to perform exercises
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- sit-to-stand test, six-minutes walking 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.
sit-to-stand testProcedure or surgery
six-minutes walking testProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| sit-to-stand | Experimental | To perform a sit-to-stand test Receives: Procedure: sit-to-stand test |
| six minute walking test | Active comparator | To perform a six minutes walking test Receives: Procedure: six-minutes walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of sit-to-stand movement
Measured: 1 minute
walked distance
Measured: 6 minutes
Secondary outcomes (3)
heart rate
Measured: 6 minutes
fraction of oxygen-saturated hemoglobin measured by pulsed oximeter
Measured: 6 minutes
breathlessness measured by visual analogic scale
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631434
- Sponsor's protocol ID
- STSTCOPD
- Status last verified
- Dec 2015
- First submitted
- 25 Nov 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Sit-to-stand Test and Six-minute Walk Test in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02631434
- Acronym / sponsor ID
- STSTCOPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Dec 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.
Comparison between sit-to-stand test and six minutes walking test in chronic obstructive pulmonary disease patients
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sit-to-stand | Experimental | Procedure: sit-to-stand testTo perform a sit-to-stand test |
| six minute walking test | Active comparator | Procedure: six-minutes walking testTo perform a six minutes walking test |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinically stable for a minimum of 4 weeks
- no recent infectious exacerbations
Key exclusion criteria (2 listed)
- musculoskeletal or joint disorders
- contra-indications to perform exercises
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 |
|---|---|---|
| sit-to-stand test | Procedure or surgery | sit-to-stand |
| six-minutes walking test | Procedure or surgery | six minute walking test |
Primary outcome
number of sit-to-stand movement
Time frame: 1 minute
walked distance
Time frame: 6 minutes
3 secondary outcomes
heart rate
Time frame: 6 minutes
fraction of oxygen-saturated hemoglobin measured by pulsed oximeter
Time frame: 6 minutes
breathlessness measured by visual analogic scale
Time frame: 6 minutes
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 16 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sit-to-stand test and six-minutes walking test in people with Chronic Obstructive Pulmonary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 2 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 16 Dec 2015. 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 Belgium. 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?
number of sit-to-stand movement (time frame: 1 minute). The study lists 2 primary outcomes in all. 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 16 Dec 2015.