Comparison of the 1-min Sit-to-Stand Test to the 6-minute Walk Test in the Respiratory Functional Assessment of Pulmonary Fibrosis (LaMinute_FIP)

September 30, 2022 updated by: Groupe Hospitalier Paris Saint Joseph

Comparison of the 1-min Sit-to-Stand Test to the 6-minute Walk Test in the Respiratory Functional Assessment of Pulmonary Fibrosis: a Cross-over Trial

Fibrosing interstitial lung diseases or pulmonary fibrosis represent a heterogeneous group of progressive pulmonary pathologies, responsible for a significant morbi-mortality. They are defined by an infiltration of the pulmonary interstitium associating in a variable way an inflammatory component (deposit of inflammatory cells) and a fibrosing component (deposit of collagen). Idiopathic pulmonary fibrosis (IPF) is the most common and most severe pulmonary fibrosis. Other pulmonary fibroses are mainly represented by non-specific interstitial lung disease, pulmonary fibroses associated with connectivites, hypersensitivity pneumonitis, certain pneumoconiosis (occupational diseases) and sarcoidosis. The process of fibrosis is responsible for a loss of elasticity of the lung, leading to a decrease in lung volumes associated with an alteration of gas exchange.

In these diseases, the clinician must be able to rely on reliable means to assess the severity of the disease based mainly on the measurement of lung volumes and gas exchange, at diagnosis and in the follow-up of the patient, in order to propose the most appropriate management. Lung volumes are assessed by respiratory function tests. Forced vital capacity is the reference volume value used. Impaired gas exchange is assessed at rest by measuring carbon monoxide diffusion capacity, arterial oxygen saturation and arterial blood gases.

The functional capacity to exercise is also a very important evaluation criterion in terms of prognosis and in the follow-up of the patient. It is assessed by means of ergocycle tests which mainly determine the maximal oxygen consumption. These are relatively complex tests that require special equipment and are not routinely performed. Simpler field tests have been developed to assess functional capacity during exercise, the most widely used and validated being the 6-minute Walk Test (TM6).

Other field tests to assess functional capacity to exercise have been developed, such as the 30-second, 1-minute, and 3-minute chair lift tests, stepper tests, and step and stair tests. Among them, the 1-minute chair lift test (TLC1) is the best evaluated. It consists of sitting down and getting up from a chair as many times as possible in 1 minute. The criteria measured are mainly the number of lifts and desaturation. Thus, the fundamental advantage of the TLC1 over the TM6 is the exemption from temporal and spatial constraints since it takes only a few minutes and can be performed in a medical office. While TLC1 seems to be the most suitable, there are still a few pitfalls in substituting TLC1 for TM6 during diffuse interstitial lung disease.

First, there is only one study reporting the results of TLC1 in a healthy population. It provides a chart of results according to age. Unfortunately, only the number of lifts is reported without any data on heart rate, SaO2 or sensation of dyspnea.

In respiratory pathologies, TLC1 has been studied mainly in patients with chronic obstructive pulmonary disease (COPD) and little in PID. Unlike TM6, TLC1 is reproducible and has no learning effect in this population. Interestingly, one study found that peak desaturation and peak oxygen consumption occurred during the recovery phase some seconds after the end of the test.

Studies on TLC1 during SID do not allow us to conclude that this test can substitute for TM6. However, investigators may note certain limitations, in particular the small number of patients studied and the retrospective nature of the 2 largest of them. Above all, it seems that the use of TLC1 could be optimized by taking into account the recovery phase in the evaluation of desaturation.

The hypothesis of our study is that the TLC1 taking into account the recovery phase can replace the TM6 in the management of fibrosing PID for prognostic evaluation, patient follow-up and indication of oxygen therapy. It is more accessible and its use by all practitioners in face-to-face or telemedicine would allow a better management of these patients. Finally, the investigators hypothesize that the TLC1 will result in lower costs in the management of these patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient whose age is ≥ 18 years
  • Patient with fibrosing interstitial lung disease
  • French-speaking patient
  • Patient affiliated to a health insurance plan
  • Patient who has given free, informed and written consent

Exclusion Criteria:

  • Patient with an exacerbation of fibrosis in the last 6 months
  • Patient with comorbidities limiting exercise performance
  • Distance traveled < 200m at TM6
  • Patient on long-term oxygen therapy (LTO)
  • Patient already included in a type 1 interventional research protocol (RIPH1)
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Pregnant or breastfeeding patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TLC1_TM6
Patient doing 1-minute chair lift test (TLC1) before 6-minute Walk Test (TM6).
Other: TLC1_TM6
Following this inclusion, patients are performing 1-minute chair lift test (TLC1) before 6-minute Walk Test (TM6). Each exercise will be separated by 30 minutes during which the patient will be sitting in a waiting room.
Experimental: TM6_TLC1
Patient performing 6-minute Walk Test (TM6) before 1-minute chair lift test (TLC1)
Other: TM6_TLC1
Following this inclusion, patients are performing 6-minute Walk Test (TM6) before 1-minute chair lift test (TLC1). Each exercise will be separated by 30 minutes during which the patient will be sitting in a waiting room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Strength of the relationship between O2 desaturation obtained with WT-6 and TLC1 at Day 1
Time Frame: Day 1
This outcome corresponds to the difference of O2 desaturation obtained with TM6 and TLC1.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Equivalence of the percentage of desaturation on the TM6 and the TLC1
Time Frame: Month 6
This outcome corresponds to the Difference between initial SaO2 and final SaO2. The objective is to test the equivalence of the percentage of desaturation between these 2 parameters obtained with the TM6 and the TLC1.
Month 6
Strength of the relationship between O2 desaturation obtained with WT-6 and TLC1 at month 6
Time Frame: Month 6
This outcome corresponds to nadir of O2 desaturation obtained with TM6 and TLC1.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Jean Marc NACCACHE, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2022

Primary Completion (Anticipated)

February 28, 2024

Study Completion (Anticipated)

December 5, 2024

Study Registration Dates

First Submitted

June 29, 2022

First Submitted That Met QC Criteria

July 4, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LaMinute_FIP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe