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

Lower Limb Ischemia Clinical Trial

— LEGS GO  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226844
• Other study ID #: ID-RCB 2023-A02245-40
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Jérémy LAURENT, Dr.
• Phone: +334 66 68 33 13
• Email: jeremy.laurent[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artery Disease
• Atheromatous
• Ischemia
• Lower Limb Ischemia

Intervention

Device:
• Music therapy walking program
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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 12
Primary	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
Secondary	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
Secondary	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	Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 : Using the smartphone,; Use of BeatMove; Use of ankle sensors; Physical problems encountered during rehabilitation sessions; Medical problems; The problem of time and organization; Motivation problem; Other problems	Week 4
Secondary	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 : Using the smartphone,; Use of BeatMove; Use of ankle sensors; Physical problems encountered during rehabilitation sessions; Medical problems; The problem of time and organization; Motivation problem; Other problems	Week 4
Secondary	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 : Using the smartphone,; Use of BeatMove; Use of ankle sensors; Physical problems encountered during rehabilitation sessions; Medical problems; The problem of time and organization; Motivation problem; Other problems	Week 8
Secondary	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 : Using the smartphone,; Use of BeatMove; Use of ankle sensors; Physical problems encountered during rehabilitation sessions; Medical problems; The problem of time and organization; Motivation problem; Other problems	Week 8
Secondary	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 : Using the smartphone,; Use of BeatMove; Use of ankle sensors; Physical problems encountered during rehabilitation sessions; Medical problems; The problem of time and organization; Motivation problem; Other problems	Week 12
Secondary	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 : Using the smartphone,; Use of BeatMove; Use of ankle sensors; Physical problems encountered during rehabilitation sessions; Medical problems; The problem of time and organization; Motivation problem; Other problems	Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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