Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?

Last updated: April 2, 2025
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Claudication

Peripheral Arterial Occlusive Disease

Peripheral Arterial Disease (Pad)

Treatment

Music therapy walking program

Clinical Study ID

NCT06226844
ID-RCB 2023-A02245-40
  • Ages > 18
  • All Genders

Study Summary

Vascular rehabilitation for arteriopathy of the lower limbs remains little known in France, despite its good results. There are very few rehabilitation centres, and they are overcrowded and expensive. Outpatient walking rehabilitation is under-used, despite recommendations (4). One of the difficulties is getting patients to adhere to the treatment sufficiently and for a long time. According to the Fédération Française de Musicothérapie (FFM), this is a care practice based on sound or musical mediation with the aim of supporting, accompanying or re-educating a patient. Music is used as a means of expression, communication, structuring and relational analysis.The benefits of music therapy for our bodies and our behavior are numerous, including improvements in cognitive functions (attention, memory), psychomotor functions (agility, mobility, coordination) and social-emotional functions (healthymind website 10/03/2021).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with stage II arterial obliteration of the lower limbs (Leriche and Fontaineclassification) 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 lowerlimbs

  • Patient on an optimised vasculoprotective medical treatment (statin, antiplateletagent, 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

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.

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Music therapy walking program
Phase:
Study Start date:
June 14, 2024
Estimated Completion Date:
November 01, 2027

Study Description

Atheromatous obliterative arterial disease of the lower limbs at the stage of exertional ischaemia is characterised by intermittent claudication, defined as pain in the lower limbs on walking, forcing the patient to stop for a few minutes after a distance that varies according to the severity of the arterial damage. Physical exercise, and walking training in particular, plays a fundamental role in the management of patients with arterial disease. The beneficial effects of exercise are well known. A recent Cochrane review showed that exercise improves pain-free walking distance and maximum walking distance by at least 100% in patients with arterial hypertension (2). Exercise also significantly reduces total and cardiovascular mortality (3).

In the case of intermittent claudication, medical treatment with supervised vascular rehabilitation is recommended in rehabilitation centres or on an outpatient basis. Vascular rehabilitation for arteriopathy of the lower limbs remains little known in France, despite its good results. There are very few rehabilitation centres, and they are overcrowded and expensive. Outpatient walking rehabilitation is under-used, despite recommendations (4). One of the difficulties is getting patients to adhere to the treatment sufficiently and for a long time.

Musico therapy : According to the Fédération Française de Musicothérapie (FFM), this is a care practice based on sound or musical mediation with the aim of supporting, accompanying or re-educating a patient. Music is used as a means of expression, communication, structuring and relational analysis.

The benefits of music therapy for our bodies and our behavior are numerous, including improvements in cognitive functions (attention, memory), psychomotor functions (agility, mobility, coordination) and social-emotional functions (healthymind website 10/03/2021).

Connect with a study center

  • CHU de Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

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