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Clinical Trials in France / NCT07445750
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Sports Shoes and the Six-Minute Walk Test in COPD

NCT07445750 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-04-01
Last updated
2026-03-03

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)DyspnoeaExercise Intolerance

Investigational drug(s) / intervention(s)

Active Sports ShoesUsual Shoes

Active Sports Shoes: Biomechanically optimised footwear featuring high energy-return cushioning, rocker sole geometry, and rigid inserts, worn during walking and stair-climbing tests to assess impact on physical performance in COPD patients.

Usual Shoes: The patient's own everyday footwear, worn during walking and stair-climbing tests, serving as a control condition to compare with biomechanically optimised sports shoes.

Study summary

COPD: A Leading Cause of Respiratory Disability COPD, primarily linked to smoking, affects 3.5 million people in France and causes 15,000 deaths each year. It is a major source of disability, particularly due to dyspnoea, which affects one in three patients. Around 400,000 patients are registered under long-term conditions (ALD), and 200,000 receive home-based respiratory support. The most severe cases fall under the category of chronic respiratory failure-a term also applicable to other respiratory or neuromuscular diseases.

Walking Exposes Physical Limitations In patients with respiratory failure, walking rapidly induces disabling dyspnoea, as it may represent their maximal effort. This severely limits autonomy and quality of life. To improve exercise tolerance, clinicians rely on pulmonary rehabilitation (exercise reconditioning, bronchodilators, oxygen therapy). When these measures are insufficient, mobility aids such as scooters or electric scooters may help, although they have limitations (cost, bulkiness, muscular deconditioning).

The Six-Minute Walk Test (6MWT): A Key Tool The 6MWT is a standardised test that assesses walking distance, dyspnoea, heart rate, and oxygenation. It is used to evaluate the severity and prognosis of respiratory failure and to measure response to treatment. It is integrated into prognostic indices and criteria for assessing the effectiveness of rehabilitation. The only non-standardised parameter remains the type of footwear worn.

Research Hypothesis Some so-called "active" sports shoes enhance walking by design-through cushioning, rocker soles, and rigid inserts-which store and return impact energy to assist propulsion. We hypothesise that wearing such shoes could improve walking performance in COPD patients, as reflected by a greater distance on the 6MWT. If confirmed, this simple and low-cost solution could meaningfully improve the daily lives of many patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 or older * Diagnosed with COPD according to standard criteria * Severe to very severe airflow obstruction (FEV₁ \< 50% predicted, within 12 months) * Dyspnoea grade 3 or 4 on the mMRC scale * Currently hospitalised in the respiratory rehabilitation unit * Clinical indication for six-minute walk test * Provided written informed consent Non inlcusion Criteria: * Any respiratory condition other than COPD * Neurological, neuromuscular, orthopaedic or rheumatological conditions affecting gait or balance * Uncorrected visual or hearing impairment * Cognitive or psychiatric disorders interfering with instructions * Contraindications to exercise testing (e.g. unstable angina, recent myocardial infarction, severe uncontrolled hypertension, resting HR \>120 bpm) * Pregnancy or breastfeeding * Inability to understand French * No health insurance coverage * Under legal protection (e.g. guardianship) * Participation in another interventional or randomised clinical trial * Habitual use of active sports shoes

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Pitié Salpêtrière Hospital - Department of pneumology Paris France

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07445750 on ClinicalTrials.gov ↗ ← All trials in France