Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06226844
Other study ID # ID-RCB 2023-A02245-40
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Withdrawn NCT02408991 - Use Art-assist and Neupogen to Treat Chronic Limb Ischemia Phase 4
Completed NCT02369809 - Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia Phase 4
Not yet recruiting NCT05569369 - Endovascular Management of Combined Common Femoral and Superficial Femoral Arteries Lesions N/A
Active, not recruiting NCT02856230 - An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK) Phase 2/Phase 3
Not yet recruiting NCT03295539 - Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System N/A
Not yet recruiting NCT04277702 - Cysteinyl Leukotriene Antagonist in Atherosclerosis Inhibition in Patients After Endovascular Treatment Due to Peripheral Arterial Disease Phase 3
Recruiting NCT02304588 - Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot Phase 1
Recruiting NCT01937416 - Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia Phase 1
Completed NCT05601349 - TeleEducation for Implementing a Clinical Practice Guideline For Amputees N/A
Active, not recruiting NCT01305863 - Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft N/A
Completed NCT04533035 - Lower Limb Tissue Oxygenation Using Near-infrared Spectroscopy During Hallux Valgus Operation
Recruiting NCT06416644 - The PORTuguese Registry of Supera Supported Femoral-Fopliteal Revascularization (SupPORT Registry) N/A
Completed NCT03910062 - Lower Limb Surveillance During VA-ECLS