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Idiopathic Pulmonary FibrosisST2-IPFNCT03268915

Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test

A study testing 3 minutes sit-to-stand test in people with Idiopathic Pulmonary Fibrosis, run by University Hospital, Grenoble at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to evaluate the reproductibility and the performance of the 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis. To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis in 2 centers (Grenoble university hospital and Lyon university… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
3 minutes sit-to-stand test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
2 sitesFrance
Study dates
9 Feb 2017to 9 Dec 2018
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

  • man or woman aged less than 85 years
  • patients with Idiopathic Pulmonary Fibrosis without any acute exacerbation during 4 months before the inclusion
  • Non-opposition to participation in research
  • Patient with 6 minutes walk test > 200 meters (with or without oxygen therapy)

Who cannot join

  • Patient with reduced locomotor activity, or joint pain that compromises the performance of the tests
  • Patient with 6 minutes walk test < 200 meters
  • Patient with an other etiology of pulmonary fibrosis
  • Other significant pulmonary diseases
  • Patient with unstable cardiac disease
  • Patient who may be, according to the investigator's assessment, not cooperating or respecting the obligations inherent in participating to the study.
  • Opposition to participation in research

Trial locations and contacts

2 sites in 1 country.

France2 sites
  • CHU Grenoble Alpes

    La Tronche, 38700

  • Groupement Hospitalier Est

    Lyon, 69677

Other trials in France

About this study

Official title: Assessment of the Reproducibility of the 3 Minutes Sit-to-stand Test in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study is designed to evaluate the reproductibility and the performance of the 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis.

To do this, the investigators are recruiting 40 patients with idiopathic pulmonary fibrosis in 2 centers (Grenoble university hospital and Lyon university hospital).

Read more

Patients had to achieve an effort test on a cycle ergometer. 2 visits are planned in the hospital. During each visit, patients will perform a 3 minutes sit-to-stand test, a 1 minute sit-to-stand test and a 6 minutes walk test. During the second visit, patients will also perform a 3 minutes sit-to-stand test with measurement of oxygen uptake.

The investigators will then analyse the results by comparing numbers of cycle, functional response and symptoms during the 3 minutes sit-to-stand test of the 2 visits. The investigators will also compare the functional response obtained during the 3 minutes sit-to-stand test, the 1 minute sit-to-stand test and the 6 minutes walk test.

Finally, the investigators will compare the maximal values of oxygen uptake, respiration rate and expired volume obtained during the 3 minutes sit-to-stand test to the effort test on cycle ergometer.

Being tested
3 minutes sit-to-stand test
Keywords
Idiopathic pulmonary fibrosis, 3 minutes sit-to-stand test, Interindividual reproductibility
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3 minutes sit-to-stand testDiagnostic test

    Also called 6 minutes walk test, 1 minute sit-to-stand test, 3 minutes sit-to-stand test with oxygen uptake measurement

    3 minutes sit-to-stand test, 1 minute sit-to-stand test, 6 minutes walk test will be performed 2 times for each patients 3 minutes sit-to-stand test with oxygen uptake measurement will be performed one time for each patient

Study groups in NCT03268915
Study groupRoleWhat they receive
patient with idiopathic pulmonary fibrosisExperimentalNot described
Receives: Diagnostic Test: 3 minutes sit-to-stand test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reproductibility of the 3 minutes sit-to-stand test in patient with idiopathic pulmonary fibrosis

    Evaluate the reproductibility for the number of rise and down during the 3 minutes sit-to-stand test of the 2 visits (the investigators will compare the number of rise and sit during the 3 minutes sit-to-stand test of the 2 visits to see if they are similar)

    Measured: 2 days

Secondary outcomes (9)
  1. Functional response during the 3 minutes sit-to-stand test: Oxygen saturation

    Evaluate the reproductibility of functional response (oxygen saturation) during the 3 minutes sit-to-stand test

    Measured: 2 days

  2. 3 minutes sit-to-stand test compared to the 6 minutes walk test: oxygen saturation

    compared oxygen saturation during the 3 minutes sit-to-stand test to the 6 minutes walk test

    Measured: 2 days

  3. 1 minute sit-to-stand test compared to 3 minutes sit-to-stand: oxygen saturation

    Compared oxygen saturation during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test

    Measured: 2 days

  4. Functional response during the 3 minutes sit-to-stand test: Heart rate

    Evaluate the reproductibility of functional response (heart rate) during the 3 minutes sit-to-stand test

    Measured: 2 days

  5. Functional response during the 3 minutes sit-to-stand test: symptoms

    Evaluate the reproductibility of functional response (symptoms) during the 3 minutes sit-to-stand test

    Measured: 2 days

  6. 3 minutes sit-to-stand test compared to the 6 minutes walk test: heart rate

    Compared heart rate during the 3 minutes sit-to-stand test to the 6 minutes walk test

    Measured: 2 days

  7. 3 minutes sit-to-stand test compared to the 6 minutes walk test: symptoms

    Compared symptoms during the 3 minutes sit-to-stand test to the 6 minutes walk test

    Measured: 2 days

  8. 1 minute sit-to-stand test compared to 3 minutes sit-to-stand: heart rate

    Compared heart rate during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test

    Measured: 2 days

  9. 1 minute sit-to-stand test compared to 3 minutes sit-to-stand: symptoms

    Compared symptoms during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2017
  2. Study start9 Feb 2017
  3. Primary completion9 Dec 2018
  4. Study completion9 Dec 2018

Resources

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
Not applicable
Intervention model
Single group
Model description
The investigators want to test the reproductibility of a 3 minutes sit-to-stand test in patients with idiopathic pulmonary fibrosis. For this, patient perform the test during 2 visits and the investigators are going to compare the results of the two visits.
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03268915
Sponsor's protocol ID
EssaisCliniques_TCL3-FPI
Acronym
ST2-IPF
Status last verified
Aug 2019
First submitted
21 Jul 2017
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • King TE Jr, Pardo A, Selman M. Idiopathic pulmonary fibrosis. Lancet. 2011 Dec 3;378(9807):1949-61. doi: 10.1016/S0140-6736(11)60052-4. Epub 2011 Jun 28.

    PubMed 21719092
  • Cottin V, Crestani B, Valeyre D, Wallaert B, Cadranel J, Dalphin JC, Delaval P, Israel-Biet D, Kessler R, Reynaud-Gaubert M, Cordier JF, Aguilaniu B, Bouquillon B, Carre P, Danel C, Faivre JB, Ferreti G, Just N, Kouzan S, Lebargy F, Marchand Adam S, Philippe B, Prevot G, Stach B, Thivolet-Bejui F; French National Reference and Competence Centers for Rare Diseases; Societe de Pneumologies de Langue Francaise. [French practical guidelines for the diagnosis and management of idiopathic pulmonary fibrosis. From the National Reference and the Competence centers for rare diseases and the Societe de Pneumologie de Langue Francaise]. Rev Mal Respir. 2013 Dec;30(10):879-902. doi: 10.1016/j.rmr.2013.09.007. Epub 2013 Oct 25. No abstract available. French.

    PubMed 24314711
  • Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

    PubMed 21471066
  • Nalysnyk L, Cid-Ruzafa J, Rotella P, Esser D. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012 Dec 1;21(126):355-61. doi: 10.1183/09059180.00002512.

    PubMed 23204124
  • Huang XF, Gao F, Xue ZQ, Wang Y, Xu GW. [Multifactorial analysis of survival in breast cancer]. Zhonghua Zhong Liu Za Zhi. 1988 Mar;10(2):117-9. Chinese.

    PubMed 3208648
  • du Bois RM, Weycker D, Albera C, Bradford WZ, Costabel U, Kartashov A, Lancaster L, Noble PW, Sahn SA, Szwarcberg J, Thomeer M, Valeyre D, King TE Jr. Six-minute-walk test in idiopathic pulmonary fibrosis: test validation and minimal clinically important difference. Am J Respir Crit Care Med. 2011 May 1;183(9):1231-7. doi: 10.1164/rccm.201007-1179OC. Epub 2010 Dec 3.

    PubMed 21131468
  • Nathan SD, du Bois RM, Albera C, Bradford WZ, Costabel U, Kartashov A, Noble PW, Sahn SA, Valeyre D, Weycker D, King TE Jr. Validation of test performance characteristics and minimal clinically important difference of the 6-minute walk test in patients with idiopathic pulmonary fibrosis. Respir Med. 2015 Jul;109(7):914-22. doi: 10.1016/j.rmed.2015.04.008. Epub 2015 Apr 24.

    PubMed 25956020
  • 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.

    PubMed 12091180
  • Jones CJ, Rikli RE, Beam WC. A 30-s chair-stand test as a measure of lower body strength in community-residing older adults. Res Q Exerc Sport. 1999 Jun;70(2):113-9. doi: 10.1080/02701367.1999.10608028.

    PubMed 10380242
  • Buatois S, Miljkovic D, Manckoundia P, Gueguen R, Miget P, Vancon G, Perrin P, Benetos A. Five times sit to stand test is a predictor of recurrent falls in healthy community-living subjects aged 65 and older. J Am Geriatr Soc. 2008 Aug;56(8):1575-7. doi: 10.1111/j.1532-5415.2008.01777.x. No abstract available.

    PubMed 18808608
  • Macfarlane DJ, Chou KL, Cheng YH, Chi I. Validity and normative data for thirty-second chair stand test in elderly community-dwelling Hong Kong Chinese. Am J Hum Biol. 2006 May-Jun;18(3):418-21. doi: 10.1002/ajhb.20503.

    PubMed 16634026
  • Hill CJ, Denehy L, Holland AE, McDonald CF. Measurement of functional activity in chronic obstructive pulmonary disease: the grocery shelving task. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):402-9. doi: 10.1097/HCR.0b013e31818c3c65.

    PubMed 19008696
  • Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9. doi: 10.1080/15412550903156317.

    PubMed 19863362
  • Brodin E, Ljungman S, Sunnerhagen KS. Rising from a chair: a simple screening test for physical function in predialysis patients. Scand J Urol Nephrol. 2008;42(3):293-300. doi: 10.1080/00365590701797556.

    PubMed 18432536
  • Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. doi: 10.1016/j.rmed.2006.05.007. Epub 2006 Jun 27.

    PubMed 16806873

Questions about this trial

What is this clinical trial studying?

A study testing 3 minutes sit-to-stand test in people with Idiopathic Pulmonary Fibrosis, run by University Hospital, Grenoble at 2 sites in France.

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 7 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 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

Reproductibility of the 3 minutes sit-to-stand test in patient with idiopathic pulmonary fibrosis (time frame: 2 days). 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 NCT03268915, which also lists 19 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 8 Aug 2019.

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