Physical Activity and Fibrosing Interstitial Lung Disease

NCT06182748 | Recruiting

• 1 other identifier: APHP230734
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Fibrotic Interstitial Lungs Diseases

Outcome Measures

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.

  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

  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

  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

  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

  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

  at initial evaluation, after 3 months of training (M3), and 6 months and 12 months following the inclusion (M6 and M12, respectively)

Study Arms (2)

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.

Other: Training on eccentric ergocycle

Training on concentric ergocycle (control group)

ACTIVE COMPARATOR

In concentric cycling, quadriceps contract to push pedals.

Other: Training on concentric ergocycle

Interventions

Training on eccentric ergocycle 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.

Also known as: Exercise training modality

Training on eccentric ergocycle (experimental group)

Training on concentric ergocycle OTHER

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

Also known as: Exercise training modality

Training on concentric ergocycle (control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Exercise and Sports Medicine Department

Bobigny, Seine Saint Denis, 93009, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 27, 2023
• Study Start: November 30, 2023
• Primary Completion: March 2, 2024
• Study Completion: January 30, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

FR (1)