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NCT Number: NCT03268915

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble Alpes, La Tronche, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 minutes sit-to-stand test

Diagnostic 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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: ST2-IPF

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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