Chronic Obstructive Pulmonary Disease(SWTiCOPD)NCT02348151
Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With COPD
A study testing Treadmill and Corridor in people with Chronic Obstructive Pulmonary Disease, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Treadmill and Corridor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Jun 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically stable
- not dependent on oxygen to exercise
- diagnosis of COPD according to the GOLD
Who cannot join
- cognitive deficit or musculoskeletal
- in process of exacerbation
- have performed pulmonary rehabilitation
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Patricia Lira dos Santos
Mogi das Cruzes, São Paulo/Mogi Das Cruzes, 08773535
Patricia L Santos, Profissional, 551198408-4006, patylira22@hotmail.com
Ivan A Santos, Profissional, 551198690-6392, ivan.santos81@yahoo.com.br
About this study
Official title: Analysis of Metabolic and Ventilatory Demands During the Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With Chronic Obstructive Pulmonary Disease (COPD)
It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD patients' functional capacity. In the literature, there are still some controversies about performing the test on a treadmill or in a corridor and whether there is interference with the distance walked. Our hypothesis is that there is no interference with the distance walked, and thus we have one more option to perform the test in case there is no 10-meter corridor available.
Read the detailed description
Spirometry tests will be performed using ULTIMA CPX equipment. Volunteers will perform the tests twice, on different days (see protocol description), in a corridor and on a treadmill, until reaching their limit of tolerance. In the test performed on the treadmill and in the one performed in the corridor, subjects will simultaneously use the VO 2000. And the volunteers will fill out the Saint George's Respiratory Questionnaire (SGRQ).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Treadmill, Corridor
- Keywords
- COPD, SWTi, Treadmill
- 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.
TreadmillOther
The volunteers will perform the shuttle walk test on the treadmill
CorridorOther
The volunteers will perform the shuttle walk test on the corridor
| Study group | Role | What they receive |
|---|---|---|
| Treadmill | Experimental | The Shuttle is going to play on treadmill Receives: Other: Treadmill |
| Corridor | Active comparator | The Shuttle is going to play on corridor Receives: Other: Corridor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance reached in shuttle walk test
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Lira dos Santos, University of Nove de Julho
- Investigators
- Patrícia L Santos, Professional, Principal investigator, 551198408-4006
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348151
- Sponsor's protocol ID
- DPOCPC
- Acronym
- (SWTiCOPD)
- Status last verified
- Mar 2015
- First submitted
- 22 Jan 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
PubMed 1494764Stevens D, Elpern E, Sharma K, Szidon P, Ankin M, Kesten S. Comparison of hallway and treadmill six-minute walk tests. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1540-3. doi: 10.1164/ajrccm.160.5.9808139.
PubMed 10556117
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Metabolic and Ventilatory Demands During the Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02348151
- Acronym / sponsor ID
- (SWTiCOPD) / DPOCPC
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, SWTi, Treadmill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 28 Jan 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.
It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD patients' functional capacity. In the literature, there are still some controversies about performing the test on a treadmill or in a corridor and whether there is interference with the distance walked. Our hypothesis is that there is no interference with the distance walked, and thus we have one more option to perform the test in case there is no 10-meter corridor available.
Detailed description
Spirometry tests will be performed using ULTIMA CPX equipment. Volunteers will perform the tests twice, on different days (see protocol description), in a corridor and on a treadmill, until reaching their limit of tolerance. In the test performed on the treadmill and in the one performed in the corridor, subjects will simultaneously use the VO 2000. And the volunteers will fill out the Saint George's Respiratory Questionnaire (SGRQ).
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill | Experimental | Other: TreadmillThe Shuttle is going to play on treadmill |
| Corridor | Active comparator | Other: CorridorThe Shuttle is going to play on corridor |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinically stable
- not dependent on oxygen to exercise
- diagnosis of COPD according to the GOLD
Key exclusion criteria (3 listed)
- cognitive deficit or musculoskeletal
- in process of exacerbation
- have performed pulmonary rehabilitation
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 |
|---|---|---|
| TreadmillThe volunteers will perform the shuttle walk test on the treadmill | Other | Treadmill |
| CorridorThe volunteers will perform the shuttle walk test on the corridor | Other | Corridor |
Primary outcome
The distance reached in shuttle walk test
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Results publication: PubMed 1494764Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
- Results publication: PubMed 10556117Stevens D, Elpern E, Sharma K, Szidon P, Ankin M, Kesten S. Comparison of hallway and treadmill six-minute walk tests. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1540-3. doi: 10.1164/ajrccm.160.5.9808139.
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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.
Patrícia L Santos, Professional principal investigator
551198408-4006
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill and Corridor in people with Chronic Obstructive Pulmonary Disease, run by University of Nove de Julho at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 10 Mar 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernanda C Lanza, PhD (55113385-9241, lanza@uninove.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance reached in shuttle walk test (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02348151, which also lists 2 linked publications.
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 10 Mar 2015.