Chronic Obstructive Pulmonary DiseaseNCT00660738
Functional Tests in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
Objectives: to evaluate and compare the responses to the various functional tests, and the concordance between the six-minute walk test in hallway (6MWT) and the of oval track (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute step test (6MST) and the sit-to-stand test (STST)… Read more about this study
- Who is it for?
- Ages 55 to 81 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 11 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Feb 2008
- Phase
- Observational
- 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 55 to 81 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: chronic obstructive pulmonary disease.
Who may be able to join
- Tiffeneau index<70% e 30%<FEV1<80% predict;
- no presenting exacerbation during the study period;
- clinical stability for the four weeks preceding the study outset;
- no-smokers or ex-smokers.
Who cannot join
- being incapable of understanding the scales and questionary;
- being unable to perform the tests.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Special Unit of Respiratory Physiotherapy of Federal University of Sao Carlos (UFSCar)
São Carlos, São Paulo, 676
About this study
Official title: Comparison of Different Functional Tests and Relation With Functional State and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
Objectives: to evaluate and compare the responses to the various functional tests, and the concordance between the six-minute walk test in hallway (6MWT) and the of oval track (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of life. Methods: Ten patients with COPD (71±8years, FEV1<80%predicted) were assessed using the functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and the Medical Research Council scales; and the quality of life was assessed using the St George's Respiratory Questionnaire (SGRQ).
Read the detailed description
Results: In the interests analysis, there was lower walking distance in the 6MWTT and 6MWTTI was observed, to compare in the 6MWT and 6MWToT; the ΔSp,O2 (delta of arterial oxygen saturation measured by pulse oximeter) in the 6MWTTI was significantly greater that in the 6MWT, but not between to change in dyspnea and fatigue/pain in the lower-limbs between rest and exercise of peak (Δ). Concordance and correlation was observed between the lower Sp,O2 of the 6MWT with the 6MWToT, 6MWTT, 6MWTTI, 6MST and STST. Strong correlations was observed between the performances on the 6MST and 6MWT, 6MWToT and 6MWTT; and between the physical activity domain of the SGRQ with the performances in the 6MWT, 6MWToT, 6MWTT,6MST and STST. Conclusion: The functional tests produced similar subjective responses; however, the 6MWTTI caused greater desaturation that 6MWT. The concordance between the 6MWT and the tests performed, suggests acceptable use of any these tests in the physiotherapeutic clinical routine of the individuals COPD. The tests in performed, except the 6MWTTI, shown to be indicators of the quality of life (physical activity domain).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, walking, exercise test, quality of life, dyspnea, desaturation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 01 | Patients with clinical and spirometric diagnosis of COPD, with FEV1<80% |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Bruna Varanda Pessoa, Universidade Federal de Sao Carlos
- Investigators
- Bruna Varanda Pessoa, Master, Physiotherapist, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660738
- Sponsor's protocol ID
- 074/2007
- Status last verified
- Jan 2012
- First submitted
- 10 Apr 2008
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cataneo DC, Kobayasi S, Carvalho LR, Paccanaro RC, Cataneo AJ. Accuracy of six minute walk test, stair test and spirometry using maximal oxygen uptake as gold standard. Acta Cir Bras. 2010 Apr;25(2):194-200. doi: 10.1590/s0102-86502010000200013.
PubMed 20305888Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Baarends EM, Schols AM, Mostert R, Wouters EF. Peak exercise response in relation to tissue depletion in patients with chronic obstructive pulmonary disease. Eur Respir J. 1997 Dec;10(12):2807-13. doi: 10.1183/09031936.97.10122807.
PubMed 9493665Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Cataneo DC, Cataneo AJ. Accuracy of the stair climbing test using maximal oxygen uptake as the gold standard. J Bras Pneumol. 2007 Mar-Apr;33(2):128-33. doi: 10.1590/s1806-37132007000200005. English, Portuguese.
PubMed 17724530Dal Corso S, Duarte SR, Neder JA, Malaguti C, de Fuccio MB, de Castro Pereira CA, Nery LE. A step test to assess exercise-related oxygen desaturation in interstitial lung disease. Eur Respir J. 2007 Feb;29(2):330-6. doi: 10.1183/09031936.00094006. Epub 2006 Oct 18.
PubMed 17050559Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaime A, Vassaux C, Celli BR. Distance and oxygen desaturation during the 6-min walk test as predictors of long-term mortality in patients with COPD. Chest. 2008 Oct;134(4):746-752. doi: 10.1378/chest.08-0520. Epub 2008 Jul 14.
PubMed 18625667Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
PubMed 14999112Casas A, Vilaro J, Rabinovich R, Mayer A, Barbera JA, Rodriguez-Roisin R, Roca J. Encouraged 6-min walking test indicates maximum sustainable exercise in COPD patients. Chest. 2005 Jul;128(1):55-61. doi: 10.1378/chest.128.1.55.
PubMed 16002916Dourado VZ, Tanni SE, Vale SA, Faganello MM, Sanchez FF, Godoy I. Systemic manifestations in chronic obstructive pulmonary disease. J Bras Pneumol. 2006 Mar-Apr;32(2):161-71. doi: 10.1590/s1806-37132006000200012. English, Portuguese.
PubMed 17273586Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
PubMed 17507545Hadeli KO, Siegel EM, Sherrill DL, Beck KC, Enright PL. Predictors of oxygen desaturation during submaximal exercise in 8,000 patients. Chest. 2001 Jul;120(1):88-92. doi: 10.1378/chest.120.1.88.
PubMed 11451821Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
PubMed 3342669Kovelis D, Segretti NO, Probst VS, Lareau SC, Brunetto AF, Pitta F. Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Dec;34(12):1008-18. doi: 10.1590/s1806-37132008001200005. English, Portuguese.
PubMed 19180335ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Functional Tests and Relation With Functional State and Quality of Life in Individuals With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00660738
- Acronym / sponsor ID
- 074/2007
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, walking, exercise test, quality of life, dyspnea, desaturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jan 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Apr 2008 (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.
Objectives: to evaluate and compare the responses to the various functional tests, and the concordance between the six-minute walk test in hallway (6MWT) and the of oval track (6MWToT), of treadmill (6MWTT), and of treadmill with inclination (6MWTTI), the six-minute step test (6MST) and the sit-to-stand test (STST), in patients with Chronic Obstructive Pulmonary Disease (COPD), and to correlate the responses with functional state and quality of life. Methods: Ten patients with COPD (71±8years, FEV1<80%predicted) were assessed using the functional tests. A dyspnea was assessed using the London Chest Activity of Daily Living and the Medical Research Council scales; and the quality of life was assessed using the St George's Respiratory Questionnaire (SGRQ).
Detailed description
Results: In the interests analysis, there was lower walking distance in the 6MWTT and 6MWTTI was observed, to compare in the 6MWT and 6MWToT; the ΔSp,O2 (delta of arterial oxygen saturation measured by pulse oximeter) in the 6MWTTI was significantly greater that in the 6MWT, but not between to change in dyspnea and fatigue/pain in the lower-limbs between rest and exercise of peak (Δ). Concordance and correlation was observed between the lower Sp,O2 of the 6MWT with the 6MWToT, 6MWTT, 6MWTTI, 6MST and STST. Strong correlations was observed between the performances on the 6MST and 6MWT, 6MWToT and 6MWTT; and between the physical activity domain of the SGRQ with the performances in the 6MWT, 6MWToT, 6MWTT,6MST and STST. Conclusion: The functional tests produced similar subjective responses; however, the 6MWTTI caused greater desaturation that 6MWT. The concordance between the 6MWT and the tests performed, suggests acceptable use of any these tests in the physiotherapeutic clinical routine of the individuals COPD. The tests in performed, except the 6MWTTI, shown to be indicators of the quality of life (physical activity domain).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 01 | – | –Patients with clinical and spirometric diagnosis of COPD, with FEV1<80% |
Who may qualify
- Ages
- 55 to 81 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic obstructive pulmonary disease.
Key inclusion criteria (4 listed)
- Tiffeneau index<70% e 30%<FEV1<80% predict;
- no presenting exacerbation during the study period;
- clinical stability for the four weeks preceding the study outset;
- no-smokers or ex-smokers.
Key exclusion criteria (2 listed)
- being incapable of understanding the scales and questionary;
- being unable to perform the tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 24 Jan 2012.
- Background: PubMed 20305888Cataneo DC, Kobayasi S, Carvalho LR, Paccanaro RC, Cataneo AJ. Accuracy of six minute walk test, stair test and spirometry using maximal oxygen uptake as gold standard. Acta Cir Bras. 2010 Apr;25(2):194-200. doi: 10.1590/s0102-86502010000200013.
- Results publication: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Results publication: PubMed 9493665Baarends EM, Schols AM, Mostert R, Wouters EF. Peak exercise response in relation to tissue depletion in patients with chronic obstructive pulmonary disease. Eur Respir J. 1997 Dec;10(12):2807-13. doi: 10.1183/09031936.97.10122807.
- Results publication: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Results publication: PubMed 17724530Cataneo DC, Cataneo AJ. Accuracy of the stair climbing test using maximal oxygen uptake as the gold standard. J Bras Pneumol. 2007 Mar-Apr;33(2):128-33. doi: 10.1590/s1806-37132007000200005. English, Portuguese.
- Results publication: PubMed 17050559Dal Corso S, Duarte SR, Neder JA, Malaguti C, de Fuccio MB, de Castro Pereira CA, Nery LE. A step test to assess exercise-related oxygen desaturation in interstitial lung disease. Eur Respir J. 2007 Feb;29(2):330-6. doi: 10.1183/09031936.00094006. Epub 2006 Oct 18.
- Results publication: PubMed 18625667Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaime A, Vassaux C, Celli BR. Distance and oxygen desaturation during the 6-min walk test as predictors of long-term mortality in patients with COPD. Chest. 2008 Oct;134(4):746-752. doi: 10.1378/chest.08-0520. Epub 2008 Jul 14.
- Results publication: PubMed 14999112Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. doi: 10.1056/NEJMoa021322.
- Results publication: PubMed 16002916Casas A, Vilaro J, Rabinovich R, Mayer A, Barbera JA, Rodriguez-Roisin R, Roca J. Encouraged 6-min walking test indicates maximum sustainable exercise in COPD patients. Chest. 2005 Jul;128(1):55-61. doi: 10.1378/chest.128.1.55.
- Results publication: PubMed 17273586Dourado VZ, Tanni SE, Vale SA, Faganello MM, Sanchez FF, Godoy I. Systemic manifestations in chronic obstructive pulmonary disease. J Bras Pneumol. 2006 Mar-Apr;32(2):161-71. doi: 10.1590/s1806-37132006000200012. English, Portuguese.
- Results publication: PubMed 17507545Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.
- Results publication: PubMed 11451821Hadeli KO, Siegel EM, Sherrill DL, Beck KC, Enright PL. Predictors of oxygen desaturation during submaximal exercise in 8,000 patients. Chest. 2001 Jul;120(1):88-92. doi: 10.1378/chest.120.1.88.
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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.
Bruna Varanda Pessoa, Master, Physiotherapist principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Sao Carlos 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 4 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 24 Jan 2012. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00660738, which also lists 25 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 24 Jan 2012.