Fibrotic Interstitial Lungs DiseasesAP-PIDNCT06182748
Physical Activity and Fibrosing Interstitial Lung Disease
A study testing Training on eccentric ergocycle and Training on concentric ergocycle in people with Fibrotic Interstitial Lungs Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrotic Interstitial Lungs Diseases
- What is being tested?
- Training on eccentric ergocycle and Training on concentric ergocycle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Exercise and Sports Medicine Department
Bobigny, Seine Saint Denis, 93009
PLANES Carole, MD, PhD, 01.48.95.56.38, carole.planes@aphp.fr
LHUISSIER FRANCOIS, 01.48.02.64.68, francois.lhuissier@aphp.fr
About this study
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
Read the 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.
- Conditions
- Fibrotic Interstitial Lungs Diseases
- Being tested
- Training on eccentric ergocycle, Training on concentric ergocycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on eccentric ergocycleOther
Also called Exercise training modality
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.
Training on concentric ergocycleOther
Also called Exercise training modality
Subjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals.
| Study group | Role | What they receive |
|---|---|---|
| Training on eccentric ergocycle (experimental group) | Experimental | 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. Receives: Other: Training on eccentric ergocycle |
| Training on concentric ergocycle (control group) | Active comparator | In concentric cycling, quadriceps contract to push pedals. Receives: Other: Training on concentric ergocycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen uptake (VO2pic) during maximal cardiopulmonary exercise testing on ergocycle
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.
Measured: 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 outcomes (11)
During exercise testing : heart rate
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
muscle oxygenation measured by near infrared spectroscopy (NIRS) (Oxygen quantity)
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start30 Nov 2023
- Primary completion2 Mar 2024
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrotic Interstitial Lungs DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182748
- Sponsor's protocol ID
- APHP230734
- Acronym
- AP-PID
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2023
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Fibrosing Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06182748
- Acronym / sponsor ID
- AP-PID / APHP230734
- Conditions
- Fibrotic Interstitial Lungs Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training on eccentric ergocycle (experimental group) | Experimental | Other: Training on eccentric ergocycleIn 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. |
| Training on concentric ergocycle (control group) | Active comparator | Other: Training on concentric ergocycleIn concentric cycling, quadriceps contract to push pedals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on eccentric ergocycleAlso: Exercise training modalitySubjects 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 | Training on eccentric ergocycle (experimental group) |
| Training on concentric ergocycleAlso: Exercise training modalitySubjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals. | Other | Training on concentric ergocycle (control group) |
Primary outcome
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.
11 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on eccentric ergocycle and Training on concentric ergocycle in people with Fibrotic Interstitial Lungs Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.