Physical Activity and Fibrosing Interstitial Lung Disease
ConditionFibrotic Interstitial Lungs Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Training on eccentric ergocycle
Other interventionSubjects 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 ergocycle
Other interventionSubjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Training on eccentric ergocycle (experimental group)Experimental treatment 1 intervention
Group B: Training on concentric ergocycle (control group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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)Secondary outcomes
1
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.
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)2
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.
Time frame
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)3
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.
Time frame
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)4
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.
Time frame
at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)Sponsors and contacts
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Source ClinicalTrials.gov