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

Idiopathic Pulmonary Fibrosis Clinical Trial

— ST2-IPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268915
• Other study ID #: EssaisCliniques_TCL3-FPI
• Status: Completed
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: December 9, 2018

Study information

• Verified date: August 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 hospital).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 9, 2018
• Est. primary completion date: December 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Diagnostic Test:
• 3 minutes sit-to-stand test
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

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	La Tronche
France	Groupement Hospitalier Est	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (19)

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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):118 — View Citation

Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. Review. — View Citation

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. — View Citation

Buatois S, Miljkovic D, Manckoundia P, Gueguen R, Miget P, Vançon 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: — View Citation

Carstensen B. Comparing methods of measurement: Extending the LoA by regression. Stat Med. 2010 Feb 10;29(3):401-10. doi: 10.1002/sim.3769. — View Citation

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, Carré P, Danel C, Faivre JB, Ferreti G, Just N, Kouzan S, Lebargy F, Marchand Adam S, Phili — View Citation

Craig CP, Reynolds SL, Airhart JW, Staab EV. Alterations in immune responses by attenuated Venezuelan equine encephalitis vaccine. I. Adjuvant effect of VEE virus infection in guinea pigs. J Immunol. 1969 May;102(5):1220-7. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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 wi — View Citation

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. Epub 2006 Jun 27. — View Citation

Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Bioche — View Citation

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. — View Citation

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, My — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days
Secondary	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	2 days