Physical Activity and Fibrosing Interstitial Lung Disease (AP-PID)

October 18, 2024 updated by: Assistance Publique - Hôpitaux de Paris
Fibrotic interstitial lungs diseases (ILD) are a group of chronic and rare diseases characterized by an altered blood oxygenation in the lung, leading to dyspnea and physical limitation. Physical training is efficient to fight vicious circle of physical deconditioning observed in ILD. Eccentric cycling is an interesting modality of endurance training, allowing better exercise tolerance and adherence while developing cardiorespiratory function. Feasibility and efficacity of eccentric cycling were shown in chronic obstructive pulmonary disease but never in ILD. The primary aim of our work is to compare concentric and eccentric cycling training on physical capacities in ILD. Moreover, we will study the effects of training on the different steps of oxygen transport at exercise, from the lung to the muscles through the blood transport. Our second goal is then to characterize the physiological mechanisms underlying the benefits of exercising in ILD patients. Evaluations will be led during one year to study the long-term effects of training

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

60 patients with fibrosing interstitial lung disease will be included in this study. Initial assessments at the beginning will be conducted for an overview of initials abilities and divided in 3 sessions. The first session (day 1) patients will be tested on maximal cardiopulmonary exercise testing with different devices to evaluate oxygen transport, and on different functional tests like 6minute walk test, sit to stand test, .. The second session (day 6) is composed by respiratory tests like spirometry, plethysmography and diffusing capacity of nitric oxyde and carbon monoxyde at rest and exercise. The last session, one week after the first (day 9), patients will performed a maximal cardiopulmonary treadmill testing, strength testing and physical activity questionnaire. Between day 1 and day 9, patients will be asked to wear an accelerometer to quantify daily physical activity and completed quality of life questionnaire. Then, patients will be randomised in control group (concentric cycling) and experimental group (eccentric cycling). They will be trained 3 times/week during 12 weeks at the same intensity, verified by gas exchange analysis (50 à 70% VO2reserve). The training is composed of aerobic training (eccentric or concentric cycling according to randomisation), muscle training and adapted sports. All assessments of the beginning will be also conducted after 12 weeks of training (3 months after inclusion) to study impact of training and between groups to compare the two cycling modalities in this population. To allow a follow-up after training, all assessments will be conducted 6 and 12 months after the inclusion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • France
    • Seine Saint Denis
      • Bobigny, Seine Saint Denis, France, 93009

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Fibrosing PID with fibrosis score > 10% of lung volume on chest CT scan
  • Be able to attend physical reconditioning 3 times a week
  • Be affiliated to a health insurance scheme
  • Sign informed consent form

Exclusion Criteria:

  • Any contraindication to physical activity (hereafter, after Dany-Michel Marcadeta, Bruno Pavy et al. Recommendations of the French Society of Cardiology for stress tests 2018)
  • Be unable to perform exercise on an ergocycle or treadmill
  • Be unable to perform a stress test, particularly for people on long-term oxygen therapy rest oxygen therapy at home
  • IRS during an exacerbation
  • Change in treatment < 3 months
  • Sarcoidosis
  • Connectivitis
  • Pregnancy in progress
  • Participation in a therapeutic intervention study
  • Patient under guardianship
  • Person subject to a legal protection measure
  • Patient on state medical aid

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training on eccentric ergocycle (experimental group)
In eccentric cycling, pedals push against the user's feet in the opposite direction, user has to slow down pedals and quadriceps muscles lengthen during contraction.
Other: Training on eccentric ergocycle
Subjects will train on eccentric ergocycles. In eccentric cycling, pedals push against the user's feet in the opposite direction, user has to slow down pedals and quadriceps muscles lengthen during contraction.
Other Names:
  • Exercise training modality
Active Comparator: Training on concentric ergocycle (control group)
In concentric cycling, quadriceps contract to push pedals.
Other: Training on concentric ergocycle
Subjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals.
Other Names:
  • Exercise training modality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximal oxygen uptake (VO2pic) during maximal cardiopulmonary exercise testing on ergocycle
Time Frame: VO2pic will be obtained at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
VO2pic is the gold standard indicator of cardiorespiratory function. In healthy people, disabled people and patients with ILD, there is a strong correlation between low VO2pic and high risk of mortality and comorbidities. It is often measured during incremental cardiopulmonary exercise testing with gas exchange measurements.Subjects have to cycle until exhaustion. VO2pic is the highest oxygen consumption recorded before test stop.
VO2pic will be obtained at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
During exercise testing : heart rate
Time Frame: All these evaluations will be obtained at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
All these evaluations will be obtained at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : ventilatory thresholds
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : power
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
power will be evaluated with handgrip test (number of repetition) Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : speed
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
Distance walked (meters) Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : distance covered on an inclined treadmill
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
distance covered on an inclined treadmill (meters) Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : Cardiac output
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : muscular oxygenation
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
muscle oxygenation measured by near infrared spectroscopy (NIRS) (Oxygen quantity)
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
During exercise testing : blood gases
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
quantity of oxygen in arterial blood These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
Functionnal fitness tests
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
number of chair lifts These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
Physical activity : IPAQ (International Physical Activity Questionnaire) score
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
Quality of life : SGRQ (ST. GEORGE'S RESPIRATORY QUESTIONNAIRE) score
Time Frame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
These evaluations show exhaustively different steps of oxygen transport, from breath to muscle extraction. Functionals tests show low level of physical fitness observed in ILD patients. Evaluation before and after training could show the impact of physical training on these parameters to improve quality of life and well being. In comparing different modalities of training, we would like to show what type of training is the most efficient for this population. As ILD patients have altered respiratory functions, evaluation before and after training could show improvement. General training can create neocapillarisation in muscle, we hypothesise that in the lung exercise training could conducted to a better diffusion in the lung, which is the core problem in fibrosing ILD.
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP230734

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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