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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3 minutes sit-to-stand test
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic pulmonary fibrosis, 3 minutes sit-to-stand test, Interindividual reproductibility

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble Alpes
  • Groupement Hospitalier Est

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient with idiopathic pulmonary fibrosis

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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

Full Information

First Posted
July 21, 2017
Last Updated
August 7, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03268915
Brief Title
Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test
Acronym
ST2-IPF
Official Title
Assessment of the Reproducibility of the 3 Minutes Sit-to-stand Test in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
December 9, 2018 (Actual)
Study Completion Date
December 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic pulmonary fibrosis, 3 minutes sit-to-stand test, Interindividual reproductibility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient with idiopathic pulmonary fibrosis
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
3 minutes sit-to-stand test
Other Intervention Name(s)
6 minutes walk test, 1 minute sit-to-stand test, 3 minutes sit-to-stand test with oxygen uptake measurement
Intervention Description
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
Primary Outcome Measure Information:
Title
Reproductibility of the 3 minutes sit-to-stand test in patient with idiopathic pulmonary fibrosis
Description
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)
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Functional response during the 3 minutes sit-to-stand test: Oxygen saturation
Description
Evaluate the reproductibility of functional response (oxygen saturation) during the 3 minutes sit-to-stand test
Time Frame
2 days
Title
3 minutes sit-to-stand test compared to the 6 minutes walk test: oxygen saturation
Description
compared oxygen saturation during the 3 minutes sit-to-stand test to the 6 minutes walk test
Time Frame
2 days
Title
1 minute sit-to-stand test compared to 3 minutes sit-to-stand: oxygen saturation
Description
Compared oxygen saturation during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test
Time Frame
2 days
Title
Functional response during the 3 minutes sit-to-stand test: Heart rate
Description
Evaluate the reproductibility of functional response (heart rate) during the 3 minutes sit-to-stand test
Time Frame
2 days
Title
Functional response during the 3 minutes sit-to-stand test: symptoms
Description
Evaluate the reproductibility of functional response (symptoms) during the 3 minutes sit-to-stand test
Time Frame
2 days
Title
3 minutes sit-to-stand test compared to the 6 minutes walk test: heart rate
Description
Compared heart rate during the 3 minutes sit-to-stand test to the 6 minutes walk test
Time Frame
2 days
Title
3 minutes sit-to-stand test compared to the 6 minutes walk test: symptoms
Description
Compared symptoms during the 3 minutes sit-to-stand test to the 6 minutes walk test
Time Frame
2 days
Title
1 minute sit-to-stand test compared to 3 minutes sit-to-stand: heart rate
Description
Compared heart rate during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test
Time Frame
2 days
Title
1 minute sit-to-stand test compared to 3 minutes sit-to-stand: symptoms
Description
Compared symptoms during the 3 minutes sit-to-stand test with 1 minute sit-to-stand test
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Groupement Hospitalier Est
City
Lyon
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Idiopathic Pulmonary Fibrosis (IPF) and the 3 Minutes Sit-to-stand Test

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