NCT07445750Not yet recruiting
Sports Shoes and the Six-Minute Walk Test in COPD
Impact of High Biomechanical Efficiency Footwear on Six-Minute Walk Test Performance in Chronic Obstructive Pulmonary Disease (COPD): A Randomised Cross-Over Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 12 Feb 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- COPD
- NCT number
- NCT07445750
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 1 Apr 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pitié Salpêtrière Hospital - Department of pneumology Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.