Reliability, Sensitivity and Validity of the 6 Minute Step Test in Chronic Obstructive Pulmonary Disease (COPD) Patients
31 ottobre 2013 aggiornato da: Valeria Amorim Pires Di Lorenzo, Universidade Federal de Sao Carlos
Evaluation of Reliability, Sensitivity and Validity of the Six Minute Step Test in Patients With Chronic Obstructive Pulmonary Disease and Its Relation With Predictors Markers of Risk of Death
Chronic Obstructive Pulmonary Disease (COPD) leads to a reduction in exercise capacity that affects the quality of life and increases mortality of these patients.
So, exercise tests are considered as an essential component of the clinical evaluation of the patients with COPD.
The objective of this study is to evaluate the reproducibility sensitivity and validity of the Six Minute Step Test (6MST) in patients with COPD and in health volunteers, and verify its relation with the "Body-Mass Index, Airways Obstruction, Dyspnea and Exercise Capacity" Index (BODE).
This Observational, Transversal, Prospective study will be conducted in the "Special Unit of Respiratory Physiotherapy", of the "Federal University of São Carlos".
To participate in this study, 120 subjects, both gender, will be invited and will be allocated in five groups: Group I (30 healthy young subjects of 17 to 27 years old), Group II (30 healthy elderly individuals of 60 to 75 years old), and patients COPD, 60 to 80 years old, with mild, moderate, severe and very severe obstruction determined by the forced expiratory volume in one second (FEV1) by forced vital capacity (FVC) relation "FEV1/FVC" <70% and FEV1 in predict percentage < 80% composing the Group III (20 COPD patients in GOLD stage I), Group IV (20 COPD patients in GOLD stage II) and Group V (20 patients COPD stages III and IV).
All subjects will be submitted to body composition and anthropometric assessment, pulmonary function test, three 6-minutes walk test (6MWT) and three 6MST.
Furthermore, the patients of the groups III, IV and V will answer the Modified Medical Research Council (mMRC) scale, and BODE index will be calculated to each of them.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
91
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
São Paulo
-
São Carlos, São Paulo, Brasile, 13561-206
- Unidade Especial de Fisioterapia Respiratória
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 75 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Young and elderly healthy subjects presented pulmonary function within the normal range, confirmed by spirometry
- Patients with clinical and spirometric diagnosis of COPD
Exclusion Criteria:
- Lung disease exacerbated
- Decompensated heart disease
- Rheumatic, neurological or orthopedic disease, preventing them from doing the tests by limiting the exercise
- Peripheral oxygen saturation < 80% without physical effort
- Subjects who does not complete the first day of evaluation
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Healthy Young Subjects
Subjects apparently healthy, with age of 18 to 27 years old.
|
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Altri nomi:
|
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Altro: Healthy Elderly subjects
Subjects apparently healthy, with age of 60 to 75 years old.
|
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Altri nomi:
|
|
Altro: COPD Patients
Patients with clinical and spirometric diagnosis of COPD
|
The patients underwent a test where they need to step up and down a 20cm test during six minutes.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
First "Six Minute Step Test" Performance
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute.
The performance will be evaluated by the number of the steps.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Step Test" Performance
Lasso di tempo: On the first or second day of evaluation (random), 30 minutes after the first 6MST.
|
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minutes.
The performance will be evaluated by the number of the climbs.
|
On the first or second day of evaluation (random), 30 minutes after the first 6MST.
|
|
Third "Six Minute Step Test" Performance
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the patient will step up and down a 20cm step during six minutes.
The performance will be evaluated by the number of the climbs.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
First "Six Minute Walk Test" Distance
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
The performance will be the distance (meters)that it walk.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Walk Test" Distance
Lasso di tempo: On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
The performance will be the distance (meters)that it walk.
|
On the first or second day of evaluation (random), 30 minutes after the first 6MWT.
|
|
Third "Six Minute Walk Test" Distance
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes.
The performance will be the distance (meters)that it walk.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
|
"Body-Mass Index, Airflow Obstruction, Dyspnea, Exercise Capacity" Index (BODE Index)
Lasso di tempo: Second day
|
It was evaluated only in the COPD patients. BODE index is a prognostic index used in COPD patients, it is a 0-10 scale, where lower values means better prognostic. It is composed by other commonly used evaluations tools in COPD, Forced Expiratory Volume in the First second (from spirometry); classification in the scale ranging from 0-3, Body-mass index, classification in the scale ranging from 0-1; Six-minute walk test distance, classification in the scale ranging from 0-3 and referred dyspnea, classification in the scale ranging from 0-3. It was only used the total score (0-10) |
Second day
|
|
First "Six Minute Walk Test" Exertion Perception
Lasso di tempo: First day or second day of the protocol (random)
|
This test was conducted by the "Rater 1", the subject walked as far as it could in a 30m corridor during 6 minutes.
The Exertion Perception will be evaluated using BORG scale.
This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt).
Lower values means that the patient feel less discomfort.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Walk Test" Exertion Perception
Lasso di tempo: First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
The Exertion Perception will be evaluated using BORG scale.
This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt).
Lower values means that the patient feel less discomfort.
|
First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
|
Third "Six Minute Walk Test" Exertion Perception
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes.
The Exertion Perception will be evaluated using BORG scale.
This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt).
Lower values means that the patient feel less discomfort.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
|
First "Six Minute Step Test" Exertion Perception
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute.
The Exertion Perception will be evaluated using BORG scale.
This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt).
Lower values means that the patient feel less discomfort.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Step Test" Exertion Perception
Lasso di tempo: First day or second day of the protocol (random), 30 minutes after the first 6MST
|
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute.The Exertion Perception will be evaluated using BORG scale.
This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt).
Lower values means that the patient feel less discomfort.
|
First day or second day of the protocol (random), 30 minutes after the first 6MST
|
|
Third "Six Minute Step Test" Exertion Perception
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the patient will step up down one 20cm step during six minute.
The Exertion Perception will be evaluated using BORG scale.
This scale is a self-reported scale, which range from 0 to 10, where 0 means none exertion perception and 10 means very intense exertion perception (the highest the patient has ever felt).
Lower values means that the patient feel less discomfort.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
|
First "Six Minute Walk Test" Peripheral Oxygen Saturation
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
It will be evaluated by a pulse oxymeter.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Walk Test" Peripheral Oxygen Saturation
Lasso di tempo: ,First day or second day of the protocol (random) 30 minutes after the first 6MWT
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
It will be evaluated by a pulse oxymeter.
|
,First day or second day of the protocol (random) 30 minutes after the first 6MWT
|
|
Third "Six Minute Walk Test" Peripheral Oxygen Saturation
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes.
It will be evaluated by a pulse oxymeter.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
|
First "Six Minute Step Test" Peripheral Oxygen Saturation
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute.
It will be evaluated by a pulse oxymeter.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Step Test" Peripheral Oxygen Saturation
Lasso di tempo: First day or second day of the protocol (random) ,30 minutes after the first 6MST
|
This test will be conducted by the "Rater 1", the patient will step up and down one 20cm step during six minute.
It will be evaluated by a pulse oxymeter .
|
First day or second day of the protocol (random) ,30 minutes after the first 6MST
|
|
Third "Six Minute Step Test" Peripheral Oxygen Saturation
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the patient will step up and down one 20cm step during six minute.
It will be evaluated by a pulse oxymeter.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
|
First "Six Minute Walk Test" Heart Rate
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
It will be evaluated by a cardio monitor.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Walk Test" Heart Rate
Lasso di tempo: First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
This test will be conducted by the "Rater 1", the subject will walk as far as it can in a 30m corridor during 6 minutes.
It will be evaluated by a cardio monitor at rest and every two minutes of the test.
|
First day or second day of the protocol (random), 30 minutes after the first 6MWT
|
|
Third "Six Minute Walk Test" Heart Rate
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the subject will walk as far as it can in a 30m corridor during 6 minutes.
It will be evaluated by a cardio monitor.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MST, the choice of the first test was random, and there was a 30 minute interval between them.
|
|
First "Six Minute Step Test" Heart Rate
Lasso di tempo: First day or second day of the protocol (random)
|
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute.
It will be evaluated by a cardio monitor.
|
First day or second day of the protocol (random)
|
|
Second "Six Minute Step Test" Heart Rate
Lasso di tempo: First day or second day of the protocol (random), 30 minutes after the first 6MST
|
This test will be conducted by the "Rater 1", the patient will step up and down a 20cm step during six minute.
It will be evaluated by a cardio monitor.
|
First day or second day of the protocol (random), 30 minutes after the first 6MST
|
|
Third "Six Minute Step Test" Heart Rate
Lasso di tempo: On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
This test will be conducted by the "Rater 2", the patient will step up and down a 20cm step during six minute.
It will be evaluated by a cardio monitor.
|
On the third day of evaluation, seven days after the first day of evaluation. Since it was performed in the same day of the third 6MWT, the choice of the first test was random, and there was a 30 minute interval between them.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Valéria Amorim Pires Di Lorenzo, PhD, Universidade Federal de São Carlos
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- ATS 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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
- Miller 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.
- Rabe 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.
- Knudson RJ, Lebowitz MD, Holberg CJ, Burrows B. Changes in the normal maximal expiratory flow-volume curve with growth and aging. Am Rev Respir Dis. 1983 Jun;127(6):725-34. doi: 10.1164/arrd.1983.127.6.725.
- Enright PL, McBurnie MA, Bittner V, Tracy RP, McNamara R, Arnold A, Newman AB; Cardiovascular Health Study. The 6-min walk test: a quick measure of functional status in elderly adults. Chest. 2003 Feb;123(2):387-98. doi: 10.1378/chest.123.2.387.
- Fromer L, Cooper CB. A review of the GOLD guidelines for the diagnosis and treatment of patients with COPD. Int J Clin Pract. 2008 Aug;62(8):1219-36. doi: 10.1111/j.1742-1241.2008.01807.x. Epub 2008 Jun 28.
- Kovelis 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.
- Casanova 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.
- Celli 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.
- Hadeli 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.
- Leung AS, Chan KK, Sykes K, Chan KS. Reliability, validity, and responsiveness of a 2-min walk test to assess exercise capacity of COPD patients. Chest. 2006 Jul;130(1):119-25. doi: 10.1378/chest.130.1.119.
- Baarends 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.
- Pinto-Plata VM, Cote C, Cabral H, Taylor J, Celli BR. The 6-min walk distance: change over time and value as a predictor of survival in severe COPD. Eur Respir J. 2004 Jan;23(1):28-33. doi: 10.1183/09031936.03.00034603.
- Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. doi: 10.1164/rccm.200407-855OC. Epub 2005 Jan 21.
- Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
- Cahalin LP, Mathier MA, Semigran MJ, Dec GW, DiSalvo TG. The six-minute walk test predicts peak oxygen uptake and survival in patients with advanced heart failure. Chest. 1996 Aug;110(2):325-32. doi: 10.1378/chest.110.2.325.
- Cataneo 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.
- Casas 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.
- Dal 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.
- Dourado 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.
- Dourado VZ, Antunes LC, Tanni SE, de Paiva SA, Padovani CR, Godoy I. Relationship of upper-limb and thoracic muscle strength to 6-min walk distance in COPD patients. Chest. 2006 Mar;129(3):551-7. doi: 10.1378/chest.129.3.551.
- Soler-Cataluna JJ, Sanchez-Sanchez L, Martinez-Garcia MA, Sanchez PR, Salcedo E, Navarro M. Mid-arm muscle area is a better predictor of mortality than body mass index in COPD. Chest. 2005 Oct;128(4):2108-15. doi: 10.1378/chest.128.4.2108.
- Pessoa BV, Arcuri JF, Labadessa IG, Costa JN, Sentanin AC, Di Lorenzo VA. Validity of the six-minute step test of free cadence in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2014 May-Jun;18(3):228-36. doi: 10.1590/bjpt-rbf.2014.0041.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2011
Completamento primario (Effettivo)
1 dicembre 2012
Completamento dello studio (Effettivo)
1 dicembre 2012
Date di iscrizione allo studio
Primo inviato
17 febbraio 2011
Primo inviato che soddisfa i criteri di controllo qualità
17 febbraio 2011
Primo Inserito (Stima)
18 febbraio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
26 novembre 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
31 ottobre 2013
Ultimo verificato
1 settembre 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TD6reprod
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .