Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:25 AM
Study NCT ID:
NCT07445750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sports Shoes and the Six-Minute Walk Test in COPD
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Impact of High Biomechanical Efficiency Footwear on Six-Minute Walk Test Performance in Chronic Obstructive Pulmonary Disease (COPD): A Randomised Cross-Over Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ChaussePnee
Brief 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.
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.
Detailed Description:
Chronic obstructive pulmonary disease (COPD) is a leading cause of respiratory disability and impaired quality of life, particularly due to exertional dyspnoea. In patients with moderate to severe disease, walking can trigger disabling breathlessness, effectively limiting autonomy and social participation. While pulmonary rehabilitation, pharmacological treatments, and oxygen therapy can improve exercise tolerance, some patients continue to experience debilitating limitations. Mobility aids such as scooters are sometimes proposed but carry risks of deconditioning and are not always practical or accessible.
The six-minute walk test (6MWT) is a standardised and widely used measure of submaximal functional capacity in COPD. It provides prognostic and therapeutic insights, but one parameter remains non-standardised: the type of footwear used by patients during the test. This study explores the hypothesis that biomechanically optimised "active" sports shoes-designed to enhance gait efficiency through energy-returning cushioning, curved ("rocker") soles, and stiff inserts-may significantly improve walking performance in individuals with COPD.
ChaussePnée is a randomised, open-label, controlled, cross-over trial comparing two walking conditions in the same patient: wearing "active" sports shoes versus their usual, "normal" shoes. The primary objective is to detect a difference in walking distance during the 6MWT between the two conditions. Secondary objectives include assessments of symptom tolerance (dyspnoea, leg fatigue), physiological responses (heart rate, oxygen saturation), perceived comfort, and biomechanical efficiency during walking and stair climbing.
Patients will be recruited during hospitalisation in a respiratory rehabilitation unit. Eligible participants will be adults with a confirmed diagnosis of COPD, with severe to very severe airflow obstruction (FEV1 \< 50% predicted), and dyspnoea classified as grade 3 or 4 on the modified Medical Research Council (mMRC) scale. All participants will have a clinical indication for 6MWT as part of their care.
Each participant will undergo two 6MWTs and two stair climbing tests on the same day, at a dedicated clinical investigation centre. The sequence of shoe conditions will be randomised. Between tests, sufficient rest periods will be ensured. Standardised instructions and outcome measures (including distance, Borg scales, comfort ratings, vital signs, and optional metabolic measurements) will be used.
An ancillary study, offered to a subset of participants, will include continuous spirometric and metabolic assessments during the tests, aiming to clarify underlying physiological mechanisms (e.g., energy expenditure, hyperventilation, dynamic hyperinflation). Motion capture and force platform analysis will quantify gait biomechanics. In-shoe pressure mapping will compare load distribution across footwear conditions.
The study plans to enrol 75 patients. Sample size was calculated based on a minimal clinically important difference of 22.8 metres in 6MWT distance, assuming an SD of 53.6m and a power of 80-90%. The main analysis will compare intra-individual differences in 6MWT distance using paired statistical tests and linear mixed models accounting for period and sequence effects. Secondary outcomes will be analysed similarly.
The study duration is 12 months, with a single study visit for each participant. Risks are minimal, as all procedures are non-invasive and part of standard respiratory evaluation. Participants will travel to the evaluation centre by covered medical transport, and no medication or biological sampling is involved. The anticipated benefit is both individual (raising awareness of the role of footwear in daily life) and collective (identifying a simple, low-cost intervention to support mobility in COPD).
The six-minute walk test (6MWT) is a standardised and widely used measure of submaximal functional capacity in COPD. It provides prognostic and therapeutic insights, but one parameter remains non-standardised: the type of footwear used by patients during the test. This study explores the hypothesis that biomechanically optimised "active" sports shoes-designed to enhance gait efficiency through energy-returning cushioning, curved ("rocker") soles, and stiff inserts-may significantly improve walking performance in individuals with COPD.
ChaussePnée is a randomised, open-label, controlled, cross-over trial comparing two walking conditions in the same patient: wearing "active" sports shoes versus their usual, "normal" shoes. The primary objective is to detect a difference in walking distance during the 6MWT between the two conditions. Secondary objectives include assessments of symptom tolerance (dyspnoea, leg fatigue), physiological responses (heart rate, oxygen saturation), perceived comfort, and biomechanical efficiency during walking and stair climbing.
Patients will be recruited during hospitalisation in a respiratory rehabilitation unit. Eligible participants will be adults with a confirmed diagnosis of COPD, with severe to very severe airflow obstruction (FEV1 \< 50% predicted), and dyspnoea classified as grade 3 or 4 on the modified Medical Research Council (mMRC) scale. All participants will have a clinical indication for 6MWT as part of their care.
Each participant will undergo two 6MWTs and two stair climbing tests on the same day, at a dedicated clinical investigation centre. The sequence of shoe conditions will be randomised. Between tests, sufficient rest periods will be ensured. Standardised instructions and outcome measures (including distance, Borg scales, comfort ratings, vital signs, and optional metabolic measurements) will be used.
An ancillary study, offered to a subset of participants, will include continuous spirometric and metabolic assessments during the tests, aiming to clarify underlying physiological mechanisms (e.g., energy expenditure, hyperventilation, dynamic hyperinflation). Motion capture and force platform analysis will quantify gait biomechanics. In-shoe pressure mapping will compare load distribution across footwear conditions.
The study plans to enrol 75 patients. Sample size was calculated based on a minimal clinically important difference of 22.8 metres in 6MWT distance, assuming an SD of 53.6m and a power of 80-90%. The main analysis will compare intra-individual differences in 6MWT distance using paired statistical tests and linear mixed models accounting for period and sequence effects. Secondary outcomes will be analysed similarly.
The study duration is 12 months, with a single study visit for each participant. Risks are minimal, as all procedures are non-invasive and part of standard respiratory evaluation. Participants will travel to the evaluation centre by covered medical transport, and no medication or biological sampling is involved. The anticipated benefit is both individual (raising awareness of the role of footwear in daily life) and collective (identifying a simple, low-cost intervention to support mobility in COPD).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB 2025-A01137-42 | OTHER | AP-HP | View |