Clinical trial NCT06182748: Physical Activity and Fibrosing Interstitial Lung Disease
Official title: Physical Activity and Fibrosing Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrotic Interstitial Lungs Diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal oxygen uptake (VO2pic) during maximal cardiopulmonary exercise testing on ergocycle
timeFrame: 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:
measure: During exercise testing : heart rate
timeFrame: 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)
measure: During exercise testing : ventilatory thresholds
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: During exercise testing : power
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: During exercise testing : speed
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: During exercise testing : distance covered on an inclined treadmill
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: During exercise testing : Cardiac output
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: During exercise testing : muscular oxygenation
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: During exercise testing : blood gases
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: Functionnal fitness tests
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: Physical activity : IPAQ (International Physical Activity Questionnaire) score
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
measure: Quality of life : SGRQ (ST. GEORGE'S RESPIRATORY QUESTIONNAIRE) score
timeFrame: at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Exercise and Sports Medicine Department
state: Seine Saint Denis
Study officials:
References: