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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single cohort undergoing both conditions in a cross-over design: each participant performs tests with both active sports shoes and their usual shoes, in randomised order.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oxygen consumption during effort', 'timeFrame': 'Within one day (during 6MWT and stair test, ancillary study only)', 'description': 'Measurement of oxygen consumption using a portable metabolic system (Cosmed K5) to compare energy expenditure between footwear conditions in a subset of patients.'}, {'measure': 'Inspiratory capacity during effort', 'timeFrame': 'Within one day (during 6MWT and stair test, ancillary study only)', 'description': 'Spirometric measurement of inspiratory capacity during effort to assess dynamic hyperinflation, comparing footwear conditions in a subset of patients.'}], 'primaryOutcomes': [{'measure': 'Distance walked during the six-minute walk test (6MWT)', 'timeFrame': 'Within one day (two tests performed on the same day)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Completion and performance of a stair-climbing test', 'timeFrame': 'Within one day (two tests performed on the same day)', 'description': '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.'}, {'measure': 'Change in dyspnoea intensity (Borg scale)', 'timeFrame': 'Within one day (start and end of each 6MWT and stair test)', 'description': '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.'}, {'measure': 'Change in lower limb fatigue (Borg scale)', 'timeFrame': 'Within one day (end of each 6MWT and stair test)', 'description': '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.'}, {'measure': 'Change in foot pain (Borg scale)', 'timeFrame': 'Within one day (end of each 6MWT and stair test)', 'description': '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.'}, {'measure': 'Comfort rating of the shoes', 'timeFrame': 'Within one day (end of each 6MWT and stair test)', 'description': 'Perceived comfort of the shoes, scored on a 0-10 numeric rating scale (0 = extremely uncomfortable, 10 = extremely comfortable), comparing active versus usual shoes.'}, {'measure': 'Comfort rating of the shoes', 'timeFrame': 'Within one day (end of each 6MWT )', 'description': 'Short version of patient questionnaire of "confort rating of the shoes", comparing active versus usual shoes.'}, {'measure': 'Change in heart rate', 'timeFrame': 'Within one day (start and end of each 6MWT and stair test)', 'description': 'Variation in heart rate from start to end of each test, measured via pulse oximetry, comparing active versus usual shoes.'}, {'measure': 'Change in oxygen saturation (SpO₂)', 'timeFrame': 'Within one day (start and end of each 6MWT and stair test)', 'description': 'Variation in oxygen saturation measured non-invasively before and after each test, comparing active versus usual shoes.'}, {'measure': 'Change in breathing frequency', 'timeFrame': 'Within one day (start and end of each 6MWT and stair test)', 'description': 'Variation in breathing frequency from start to end of each test, comparing active versus usual shoes.'}, {'measure': 'Biomechanical gait parameters', 'timeFrame': 'Within one day (during the walking tests)', 'description': 'Kinematic analysis of gait using motion capture'}, {'measure': 'Thoracic respiratory parameters', 'timeFrame': 'Within one day (during the walking tests)', 'description': 'Kinematics of breathing using motion capture'}, {'measure': 'Foot pressure distribution', 'timeFrame': 'Within one day (static and walking trials)', 'description': 'Plantar pressure mapping collected with in-shoe sensors during brief standing and walking periods, comparing pressure distribution between active and usual shoes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Six-Minute Walk Test', 'Dyspnoea', 'Active Footwear', 'Gait', 'Biomechanics', 'Pulmonary Rehabilitation', 'Stair Climbing', 'Oxygen Saturation', 'Exercise Capacity', 'Respiratory Disability'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)', 'Dyspnoea', 'Exercise Intolerance']}, 'descriptionModule': {'briefSummary': '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.\n\nWalking 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).\n\nThe 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.\n\nResearch 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.', 'detailedDescription': '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.\n\nThe 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.\n\nChaussePnée 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.\n\nPatients 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.\n\nEach 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.\n\nAn 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.\n\nThe 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.\n\nThe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Diagnosed with COPD according to standard criteria\n* Severe to very severe airflow obstruction (FEV₁ \\< 50% predicted, within 12 months)\n* Dyspnoea grade 3 or 4 on the mMRC scale\n* Currently hospitalised in the respiratory rehabilitation unit\n* Clinical indication for six-minute walk test\n* Provided written informed consent\n\nNon inlcusion Criteria:\n\n* Any respiratory condition other than COPD\n* Neurological, neuromuscular, orthopaedic or rheumatological conditions affecting gait or balance\n* Uncorrected visual or hearing impairment\n* Cognitive or psychiatric disorders interfering with instructions\n* Contraindications to exercise testing (e.g. unstable angina, recent myocardial infarction, severe uncontrolled hypertension, resting HR \\>120 bpm)\n* Pregnancy or breastfeeding\n* Inability to understand French\n* No health insurance coverage\n* Under legal protection (e.g. guardianship)\n* Participation in another interventional or randomised clinical trial\n* Habitual use of active sports shoes'}, 'identificationModule': {'nctId': 'NCT07445750', 'acronym': 'ChaussePnee', 'briefTitle': 'Sports Shoes and the Six-Minute Walk Test in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of High Biomechanical Efficiency Footwear on Six-Minute Walk Test Performance in Chronic Obstructive Pulmonary Disease (COPD): A Randomised Cross-Over Controlled Trial', 'orgStudyIdInfo': {'id': 'APHP250735'}, 'secondaryIdInfos': [{'id': 'IDRCB 2025-A01137-42', 'type': 'OTHER', 'domain': 'AP-HP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active sports shoes', 'description': 'Wearing biomechanically optimised "active" sports shoes', 'interventionNames': ['Other: Active Sports Shoes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Shoes', 'description': 'Wearing the patient\'s usual "normal" shoes', 'interventionNames': ['Other: Usual Shoes']}], 'interventions': [{'name': 'Active Sports Shoes', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Active sports shoes']}, {'name': 'Usual Shoes', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Usual Shoes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Thomas SIMILOWSKI, Prof', 'role': 'CONTACT', 'email': 'thomas.similowski@sorbonne-universite.fr', 'phone': '+33 669767252'}, {'name': 'Anne Radenne', 'role': 'CONTACT', 'email': 'anne.radenne@aphp.fr', 'phone': '+33 142162498'}], 'facility': 'Pitié Salpêtrière Hospital - Department of pneumology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Thomas SIMILOWSKI, Prof', 'role': 'CONTACT', 'email': 'thomas.similowski@sorbonne-universite.fr', 'phone': '+33 669767252'}, {'name': 'Anne Radenne', 'role': 'CONTACT', 'email': 'anne.radenne@aphp.fr', 'phone': '+33 142162498'}], 'overallOfficials': [{'name': 'Thomas SIMILOWSKI, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AP-HP / Sorbonne University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor', 'ipdSharing': 'YES', 'description': "Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.", 'accessCriteria': 'Researchers who provide a methodologically sound proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sorbonne University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}