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Trial record 9 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test (ST2-IPF)

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ClinicalTrials.gov Identifier: NCT03268915
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.


Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Diagnostic Test: 3 minutes sit-to-stand test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Assessment of the Reproducibility of the 3 Minutes Sit-to-stand Test in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : December 9, 2018
Estimated Study Completion Date : December 9, 2018


Arm Intervention/treatment
Experimental: patient with idiopathic pulmonary fibrosis 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
Other Names:
  • 6 minutes walk test
  • 1 minute sit-to-stand test
  • 3 minutes sit-to-stand test with oxygen uptake measurement




Primary Outcome Measures :
  1. Reproductibility of the 3 minutes sit-to-stand test in patient with idiopathic pulmonary fibrosis [ Time Frame: 2 days ]
    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)


Secondary Outcome Measures :
  1. Functional response during the 3 minutes sit-to-stand test: Oxygen saturation [ Time Frame: 2 days ]
    Evaluate the reproductibility of functional response (oxygen saturation) during the 3 minutes sit-to-stand test

  2. 3 minutes sit-to-stand test compared to the 6 minutes walk test: oxygen saturation [ Time Frame: 2 days ]
    compared oxygen saturation during the 3 minutes sit-to-stand test to the 6 minutes walk test

  3. 1 minute sit-to-stand test compared to 3 minutes sit-to-stand: oxygen saturation [ Time Frame: 2 days ]
    Compared oxygen saturation during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test

  4. Functional response during the 3 minutes sit-to-stand test: Heart rate [ Time Frame: 2 days ]
    Evaluate the reproductibility of functional response (heart rate) during the 3 minutes sit-to-stand test

  5. Functional response during the 3 minutes sit-to-stand test: symptoms [ Time Frame: 2 days ]
    Evaluate the reproductibility of functional response (symptoms) during the 3 minutes sit-to-stand test

  6. 3 minutes sit-to-stand test compared to the 6 minutes walk test: heart rate [ Time Frame: 2 days ]
    Compared heart rate during the 3 minutes sit-to-stand test to the 6 minutes walk test

  7. 3 minutes sit-to-stand test compared to the 6 minutes walk test: symptoms [ Time Frame: 2 days ]
    Compared symptoms during the 3 minutes sit-to-stand test to the 6 minutes walk test

  8. 1 minute sit-to-stand test compared to 3 minutes sit-to-stand: heart rate [ Time Frame: 2 days ]
    Compared heart rate during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test

  9. 1 minute sit-to-stand test compared to 3 minutes sit-to-stand: symptoms [ Time Frame: 2 days ]
    Compared symptoms during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03268915


Contacts
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Contact: Bernard Aguilaniu +33680984146 b.aguilaniu@me.com
Contact: Sebastien Quetant +33476767575 squetant@chu-grenoble.fr

Locations
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France
CHU Grenoble Alpes Recruiting
La Tronche, France, 38700
Contact: Arnaud FEDI    +33476767575    afedi@chu-grenoble.fr   
Contact: Sebastien Quetant    +33476767575    squetant@chu-grenoble.fr   
Groupement Hospitalier Est Recruiting
Lyon, France, 69677
Contact: Jean-Charles Glerant    +33472357613    jean-charles.glerant@chu-lyon.fr   
Contact: Vincent Cottin    +33472357072    vincent.cottin@chu-lyon.fr   
Sponsors and Collaborators
University Hospital, Grenoble

Publications of Results:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03268915     History of Changes
Other Study ID Numbers: EssaisCliniques_TCL3-FPI
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
Idiopathic pulmonary fibrosis
3 minutes sit-to-stand test
Interindividual reproductibility

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial