Sports Shoes and the Six-Minute Walk Test in COPD

NCT07445750 | Not Yet Recruiting

• 2 other identifiers: APHP250735IDRCB 2025-A01137-42
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Dyspnoea; Exercise Intolerance

Keywords

COPD; Six-Minute Walk Test; Dyspnoea; Active Footwear; Gait; Biomechanics; Pulmonary Rehabilitation; Stair Climbing; Oxygen Saturation; Exercise Capacity; Respiratory Disability

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

• Completion and performance of a stair-climbing test

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

• Change in dyspnoea intensity (Borg scale)

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

• Change in lower limb fatigue (Borg scale)

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

• Change in foot pain (Borg scale)

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

• Comfort rating of the shoes

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

Other Outcomes (2)

• Oxygen consumption during effort

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

• Inspiratory capacity during effort

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

Study Arms (2)

Active sports shoes

EXPERIMENTAL

Wearing biomechanically optimised "active" sports shoes

Other: Active Sports Shoes

Usual Shoes

ACTIVE COMPARATOR

Wearing the patient's usual "normal" shoes

Other: Usual Shoes

Interventions

Active Sports Shoes OTHER

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.

Active sports shoes

Usual Shoes OTHER

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.

Usual Shoes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Sorbonne University: collaborator

Study Sites (1)

Pitié Salpêtrière Hospital - Department of pneumology

Paris, 75013, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Thomas SIMILOWSKI, Prof

  AP-HP / Sorbonne University

  STUDY DIRECTOR

Central Study Contacts

Thomas SIMILOWSKI, Prof

CONTACT

+33 669767252; thomas.similowski@sorbonne-universite.fr

Anne Radenne

CONTACT

+33 142162498; anne.radenne@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 3, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)