Clinical trial NCT06226844: Can the BeatMove Device Help Patients With Obliterative Arterial Disease of the Lower Limbs?
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atheromatous
Lower Limb Ischemia
Artery Disease
Keywords: Rehabilitation
Music therapy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients with arterial obliteration of the lower limbs at the stress ischemia stage who are eligible for a walking rehabilitation program with or without music.

Brief 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).

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
timeFrame: Week 4
measure: Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.
timeFrame: Week 4
measure: Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
timeFrame: Week 8
measure: Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.
timeFrame: Week 8
measure: Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
timeFrame: Week 12
measure: Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.
timeFrame: Week 12
Secondary outcomes:
measure: Systolic pressure index at the toe at rest. Experimental group
timeFrame: Day 0 at the time of consultation
measure: Systolic pressure index at the toe at rest. Experimental group
timeFrame: Week 12
measure: Systolic pressure index at the toe after effort. Experimental group
timeFrame: Day 0 at the time of consultation
measure: Systolic pressure index at the toe after effort. Experimental group
timeFrame: Week 12
measure: Systolic pressure index at the toe at rest. Sham group
timeFrame: Day 0 at the time of consultation
measure: Systolic pressure index at the toe at rest. Sham group
timeFrame: Week 12
measure: Systolic pressure index at the toe after effort. Sham group
timeFrame: Day 0 at the time of consultation
measure: Systolic pressure index at the toe after effort. Sham group
timeFrame: Week 12
measure: Results of the EQ-5D-5L questionnaire in the experimental group
timeFrame: Day 0 at the time of consultation
measure: Results of the EQ-5D-5L questionnaire in the experimental group
timeFrame: Week 12
measure: Results of the EQ-5D-5L questionnaire in the sham group
timeFrame: Day 0 at the time of consultation
measure: Results of the EQ-5D-5L questionnaire in the sham group
timeFrame: Week 12
measure: Phone call follow-up in the experimental group
timeFrame: Week 4
measure: Phone call follow-up in the sham group
timeFrame: Week 4
measure: Phone call follow-up in the experimental group
timeFrame: Week 8
measure: Phone call follow-up in the sham group
timeFrame: Week 8
measure: Phone call follow-up in the experimental group
timeFrame: Week 12
measure: Phone call follow-up in the sham group
timeFrame: Week 12
measure: Patient's logbook: Pre- and post-workout pain rating in the experimental group
timeFrame: Three sessions per week for 3 months throughout the training program
measure: Patient's logbook: Pre- and post-workout pain rating in the sham group
timeFrame: Three sessions per week for 3 months throughout the training program
measure: Patient's logbook: Pre- and post-workout evaluation of fatigue in the experimental group
timeFrame: Three sessions per week for 3 months throughout the training program
measure: Patient's logbook: Pre- and post-workout evaluation of fatigue in the sham group
timeFrame: Three sessions per week for 3 months throughout the training program
measure: Patient's logbook: Pre- and post-workout evaluation of motivation in the experimental group
timeFrame: Three sessions per week for 3 months throughout the training program
measure: Patient's logbook: Pre- and post-workout evaluation of motivation in the sham group
timeFrame: Three sessions per week for 3 months throughout the training program
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
References: