Physical Activity and Fibrosing Interstitial Lung Disease

NCT ID: NCT06182748

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2026-01-30

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.

Conditions

Fibrotic Interstitial Lungs Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Training on eccentric ergocycle

Intervention Type: OTHER

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 ergocycle (control group)

In concentric cycling, quadriceps contract to push pedals.

Group Type: ACTIVE_COMPARATOR

Training on concentric ergocycle

Intervention Type: OTHER

Subjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals.

Interventions

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.

Intervention Type: OTHER

Training on concentric ergocycle

Subjects will train on regular concentric ergocycles. In concentric cycling, quadriceps contract to push pedals.

Intervention Type: OTHER

Other Intervention Names

Exercise training modality; Exercise training modality

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Exercise and Sports Medicine Department

Bobigny, Seine Saint Denis, France

Site Status: RECRUITING

Countries

France

Facility Contacts

PLANES Carole, MD, PhD

Role: primary

carole.planes@aphp.fr

01.48.95.56.38

LHUISSIER FRANCOIS

Role: backup

francois.lhuissier@aphp.fr

01.48.02.64.68

Other Identifiers

APHP230734

Identifier Type: -

Identifier Source: org_study_id