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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Experimental group.
时间窗: Week 12
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.
Benefit of music therapy (delivered by the BeatMove device) in a three-month outpatient walking rehabilitation: Sham group.
时间窗: Week 12
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.
次要结局
- Systolic pressure index at the toe at rest. Sham group(Week 12)
- Systolic pressure index at the toe after effort. Sham group(Week 12)
- Patient's logbook: Pre- and post-workout pain rating in the sham group(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(Three sessions per week for 3 months throughout the training program)
- Systolic pressure index at the toe after effort. Experimental group(Week 12)
- Results of the EQ-5D-5L questionnaire in the sham group(Week 12)
- Phone call follow-up in the experimental group(Week 12)
- Patient's logbook: Pre- and post-workout evaluation of fatigue in the experimental group(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(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(Three sessions per week for 3 months throughout the training program)
- Systolic pressure index at the toe at rest. Experimental group(Week 12)
- Results of the EQ-5D-5L questionnaire in the experimental group(Week 12)
- Patient's logbook: Pre- and post-workout pain rating in the experimental group(Three sessions per week for 3 months throughout the training program)
- Phone call follow-up in the sham group(Week 12)