Using music therapy to help patients with lower limb artery disease
Evaluation of the Value of Music Therapy (BeatMove Device) in a 3-month Outpatient Walking Rehabilitation Programme for Patients With Obliterative Arterial Disease of the Lower Limbs (AOMI) at the Stress Ischaemia Stage.
This study tests whether a music therapy walking program can help people with lower limb artery disease walk better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT06226844 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of a music therapy walking program for patients suffering from stage II arterial obliteration of the lower limbs, characterized by exertional claudication. The program aims to enhance patient adherence to rehabilitation by integrating music therapy into physical exercise, which is known to improve walking distance and reduce cardiovascular mortality. Participants will be monitored for improvements in mobility and overall health outcomes as they engage in this innovative rehabilitation approach. The study is conducted at the Centre Hospitalier Universitaire de Nîmes in France.
Who should consider this trial
Good fit: Ideal candidates are patients with stage II arterial obliteration of the lower limbs who experience exertional claudication and can participate in a walking program.
Not a fit: Patients with severe mobility limitations, such as those using walking aids or with major cardiovascular co-morbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and mobility for patients with lower limb artery disease.
How similar studies have performed: While the integration of music therapy in rehabilitation is innovative, previous studies have shown positive outcomes with exercise-based rehabilitation for similar conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with stage II arterial obliteration of the lower limbs (Leriche and Fontaine classification) with exertional claudication * Systolic Pressure Index at the toe \< 0.7 but absolute value \> 30 mmHg * Steno-occlusive lesions on arterial Doppler ultrasound examination of the lower limbs * Patient on an optimised vasculoprotective medical treatment (statin, antiplatelet agent, ACE inhibitor/ARB II) * Patient who is a beneficiary or entitled beneficiary of a health insurance scheme * Patient able to understand, write and read French * Patient who has given free and informed consent Exclusion Criteria: * Patients using walking aids (cane, wheelchair) * Amputation * Patient with a walking perimeter \< 150 m * Hearing or visual impairment * Chronic ischaemia * Trophic disorders * Orthopaedic or vascular MI surgery planned within 3 months * Major cardiovascular co-morbidities (MI \< 3 months or unstable angina) * Pregnant, breast-feeding or parturient women * Patients under court protection, guardianship or curatorship.
Where this trial is running
Nîmes
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Study coordinator: Jérémy LAURENT, Dr.
- Email: jeremy.laurent@chu-nimes.fr
- Phone: +334 66 68 33 13
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.