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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group : PEMA SHAM | Sham Comparator | Patients on rehabilitation using the BeatMove device in sham mode |
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| Experimental group : PEMA BeatMove | Experimental | Patients on rehabilitation using the BeatMove device |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy walking program | Device | In the experimental group (PEMA BeatMove), patients will benefit from an outpatient walking training program with app-based performance monitoring, combined with music therapy (BeatMove device). The program comprises 36 walking training sessions, with 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. | Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks. | Week 4 |
| Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group. | Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks. | Week 4 |
| Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. | Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks. | Week 8 |
| Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group. | Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks. | Week 8 |
| Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group. | Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic pressure index at the toe at rest. Experimental group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Day 0 at the time of consultation |
| Systolic pressure index at the toe at rest. Experimental group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérémy LAURENT, Dr. | Contact | +334 66 68 33 13 | jeremy.laurent@chu-nimes.fr | |
| Anissa MEGZARI | Contact | +33466684236 | drc@chu-nimes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nîmes | Recruiting | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sham BeatMove | Device | Ambulatory gait training program with performance monitoring via an app, combined with sham music therapy (BeatMove device). The program includes 36 gait training sessions, each lasting 30 minutes. Patients will complete three walking sessions per week for three months. |
|
| Week 12 |
| Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group. | Maximum walking distance defined as the walking distance to the point of maximum muscular pain requiring stopping, during a treadmill test. Patients will have to do 3 walking sessions per week for a total duration of 12 weeks. | Week 12 |
Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation |
| Week 12 |
| Systolic pressure index at the toe after effort. Experimental group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Day 0 at the time of consultation |
| Systolic pressure index at the toe after effort. Experimental group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Week 12 |
| Systolic pressure index at the toe at rest. Sham group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Day 0 at the time of consultation |
| Systolic pressure index at the toe at rest. Sham group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Week 12 |
| Systolic pressure index at the toe after effort. Sham group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Day 0 at the time of consultation |
| Systolic pressure index at the toe after effort. Sham group | Evaluation of the impact of music therapy on distal perfusion via Systolic Pressure Index at the toe after 3 months of rehabilitation | Week 12 |
| Results of the EQ-5D-5L questionnaire in the experimental group | Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it. The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Day 0 at the time of consultation |
| Results of the EQ-5D-5L questionnaire in the experimental group | Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it. The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Week 12 |
| Results of the EQ-5D-5L questionnaire in the sham group | Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it. The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Day 0 at the time of consultation |
| Results of the EQ-5D-5L questionnaire in the sham group | Patients will complete the EQ-5D-5L quality of life questionnaire before starting the walking training program and after completing it. The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Week 12 |
| Phone call follow-up in the experimental group | Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device. The following information will be be recorded during follow-up phone calls and will include any problems encountered with :
| Week 4 |
| Phone call follow-up in the sham group | Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device. The following information will be be recorded during follow-up phone calls and will include any problems encountered with :
| Week 4 |
| Phone call follow-up in the experimental group | Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device. The following information will be be recorded during follow-up phone calls and will include any problems encountered with :
| Week 8 |
| Phone call follow-up in the sham group | Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device. The following information will be be recorded during follow-up phone calls and will include any problems encountered with :
| Week 8 |
| Phone call follow-up in the experimental group | Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device. The following information will be be recorded during follow-up phone calls and will include any problems encountered with :
| Week 12 |
| Phone call follow-up in the sham group | Patients in both groups will be followed up by a telephone call, 1 call per month, to assess compliance with the training program and monitor proper use of the device. The following information will be be recorded during follow-up phone calls and will include any problems encountered with :
| Week 12 |
| Patient's logbook: Pre- and post-workout pain rating in the experimental group | The patient's appreciation of pre- and post-workout pain will be recorded on a Lickert scale from 0 to 10 in which 0 = no pain, 10 = unbearable pain. | Three sessions per week for 3 months throughout the training program |
| Patient's logbook: Pre- and post-workout pain rating in the sham group | The patient's appreciation of pre- and post-workout pain will be recorded on a Lickert scale from 0 to 10 in which 0 = no pain, 10 = unbearable pain. | Three sessions per week for 3 months throughout the training program |
| Patient's logbook: Pre- and post-workout evaluation of fatigue in the experimental group | Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue). | Three sessions per week for 3 months throughout the training program |
| Patient's logbook: Pre- and post-workout evaluation of fatigue in the sham group | Evaluation of fatigue before and after training (Lickert scale from 0 to 10 in which 0 = no fatigue, 10 = greatest possible fatigue). | Three sessions per week for 3 months throughout the training program |
| Patient's logbook: Pre- and post-workout evaluation of motivation in the experimental group | Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation). | Three sessions per week for 3 months throughout the training program |
| Patient's logbook: Pre- and post-workout evaluation of motivation in the sham group | Evaluation of motivation before and after training (Lickert scale from 0 to 10 in which 0 = no motivation, 10 = greatest possible motivation). | Three sessions per week for 3 months throughout the training program |