Sports Shoes and the Six-Minute Walk Test in COPD

ConditionsChronic Obstructive Pulmonary Disease (COPD)Dyspnoea Exercise Intolerance

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

Active Sports Shoes
Other intervention
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
Other intervention
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.

Treatment groups

75 Participants

are divided into 2 treatment groups

Group A: Active sports shoesExperimental treatment 1 intervention

Group B: Usual ShoesActive comparator 1 intervention

Trial outcomes

Primary outcomes

Distance walked during the six-minute walk test (6MWT)

Comparison of walking distance (in metres) between two conditions-wearing active sports shoes versus usual shoes-measured in the same patient using standardised six-minute walk tests.

Time frame

Within one day (two tests performed on the same day)

Secondary outcomes

Completion and performance of a stair-climbing test

Assessment of the ability to complete one flight of stairs and related performance metrics (time taken, number of steps, need to pause), comparing the active shoes versus usual shoes condition in the same patient.

Time frame

Within one day (two tests performed on the same day)

Change in dyspnoea intensity (Borg scale)

Dyspnoea intensity will be assessed using the modified Borg Category-Ratio 10 (CR10) scale (range 0-10), where 0 will indicate "no breathlessness at all" and 10 will indicate "maximal breathlessness." Higher scores will reflect greater dyspnoea severity. Change in dyspnoea intensity will be calculated as the difference between post-intervention and baseline scores (post minus baseline), with negative values indicating an improvement (reduction) in dyspnoea.

Time frame

Within one day (start and end of each 6MWT and stair test)

Change in lower limb fatigue (Borg scale)

Fatigue intensity will be assessed using the modified Borg Category-Ratio 10 (CR10) scale (range 0-10), where 0 will indicate "no fatigue at all" and 10 will indicate "maximal fatigue." Higher scores will reflect greater fatigue severity. Change in fatigue intensity will be calculated as the difference between post-intervention and baseline scores (post minus baseline), with negative values indicating an improvement (reduction) in fatigue.

Time frame

Within one day (end of each 6MWT and stair test)

Change in foot pain (Borg scale)

Pain in the feet will be assessed using the modified Borg Category-Ratio 10 (CR10) scale (range 0-10), where 0 will indicate "no pain at all" and 10 will indicate "maximal pain." Higher scores will reflect greater pain severity. Change in foot pain intensity will be calculated as the difference between post-intervention and baseline scores (post minus baseline), with negative values indicating an improvement (reduction) in pain.

Time frame

Within one day (end of each 6MWT and stair test)

Other outcomes

Oxygen consumption during effort

Measurement of oxygen consumption using a portable metabolic system (Cosmed K5) to compare energy expenditure between footwear conditions in a subset of patients.

Time frame

Within one day (during 6MWT and stair test, ancillary study only)

Inspiratory capacity during effort

Spirometric measurement of inspiratory capacity during effort to assess dynamic hyperinflation, comparing footwear conditions in a subset of patients.

Time frame

Within one day (during 6MWT and stair test, ancillary study only)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Sorbonne University

Collaborator

Source ClinicalTrials.gov

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