Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application (APAISE)
Primary Purpose
Intermittent Claudication
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
E-REVA® app
No E-REVA® app
Sponsored by
About this trial
This is an interventional supportive care trial for Intermittent Claudication focused on measuring Intermittent claudication, peripheral arterial disease, supervised exercise therapy, home-based exercise, smartphone medical application
Eligibility Criteria
inclusion criteria :
- - Patient over 18 years old
- Patient with claudication on PAD for more than 3 months
- IPS (systolic pressure index) less than 0.90 at the level of the diseased limb
- Absence of pathology limiting walk other than PAD
- Patient having benefited from an arterial ultrasound of the lower limbs demonstrating arterial lesion
- Absence of myocardial infarction over the last 6 months
- Absence of cardiac pathology requiring surgery
- Absence of angina
- Patient affiliated or entitled to a social security system
- Patient having given his free and written consent
exclusion criteria :
- Patient who has not benefited from an arterial ultrasound of the lower limbs
All contraindications to treadmill events:
- Myocardial infarction within the last 6 months
- angina
- Symptomatic tight aortic valve stenosis
- Pathology limiting walk other than PAD
Sites / Locations
- Damien JOLLY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patients randomized to using the smartphone app
patients randomized to not using the smartphone app
Arm Description
Outcomes
Primary Outcome Measures
maximal walking distance on treadmill test
maximal walking distance on treadmill test
Secondary Outcome Measures
Quality of life assessment VascuQol-6
Walking Impairment Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05457738
Brief Title
Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application
Acronym
APAISE
Official Title
Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application : a Monocentric Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main characteristic of PAD is to limit physical activity by the appearance of claudication of the lower limbs which limits the walking distance, or the maximum distance traveled by the patient before the pain forces to stop. In daily practice, the walking distance is rarely measured at the time of treatment.
Walking rehabilitation is the first-line treatment for these patients (class 1 recommendation from the AHA 2005 and the ESC 2017 with level A evidence). According to the recommendation, a walking session must last at least 30 minutes at the rate of 3 sessions per week for a minimum of 6 months.
Walking rehabilitation should be systematically offered to all claudicating patients, whether operated on or not. It is often sufficient for mild claudication with a walking distance of more than 500 meters. Surgery should be reserved for patients in whom rehabilitation has failed and in whom the claudication is severe (walking distance less than 500 meters). Surgical intervention should not replace rehabilitation, but should be complementary.
Supervised rehabilitation in specialized centers is rarely offered because it is not easily available and involves additional expenses and constraints for the patient (transport, fewer work periods for active patients, etc.). In the absence of specialized center, simple advice is most often given to the patient, who then only has to rely on his personal motivation: this is the so-called "go home and walk".
Therefore, access to well-conducted rehabilitation is a fundamental element of the management of patients with intermittent claudication, which is currently lacking. In the age of digital health, it is necessary to develop innovative tools allowing self-rehabilitation of the patient in addition with remote monitoring by the doctor.
Recent studies have validated and highlighted the interest of using GPS technology for the evaluation of walking activity in claudicants. To date, there are 2 published examples of smartphone applications developed specifically for exercise rehabilitation. The main shortcomings of the solutions proposed in these publications are:
The need to buy a specific GPS box
Discomfort for the patient to carry the box either in a backpack or over the shoulder
The lack of means for the patient to indicate the precise moment when the pain appears
And consequently the absence of clinical analysis centered on the symptom "walk induced pain" Consumer smartphone applications for GPS activity tracking are not intended for medical use and do not indicate when pain occurs.
In this study, the University Hospital of REIMS will establish a scientific collaboration with the company VascInnove® for the use of a smartphone application, called E-REVA® which offers:
an assessment of walking activity and claudication parameters (appearance of pain, walking distance, recovery time after pain, total distance travelled, walking speed, etc.)
help with self-rehabilitation
quality of life and walking questionnaires
The main innovation is the presence of a button allowing the patient to indicate when the pain appears. The patient will be able to have access via the smartphone application to his statistics and the evolution of his performance over time. The prescribing practitioner will have access, via a secure website, to the statistics of his patient, to whom he will be able to give personalized advice during follow-up consultations.
The aim of this study is to carry out a single-centre prospective randomized stratified study (depending on whether or not patient has been revascularized) in patients with intermittent claudication who will or will not use the rehabilitation assistance smartphone application, seen in consultation for vascular surgery and vascular medicine at the University Hospital of Reims.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Intermittent claudication, peripheral arterial disease, supervised exercise therapy, home-based exercise, smartphone medical application
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients randomized to using the smartphone app
Arm Type
Experimental
Arm Title
patients randomized to not using the smartphone app
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
E-REVA® app
Intervention Description
Use of a smartphone app designed for home-based exercise therapy of patients with intermittent claudication. App's name is E-REVA®.
Intervention Type
Other
Intervention Name(s)
No E-REVA® app
Intervention Description
No use smartphone
Primary Outcome Measure Information:
Title
maximal walking distance on treadmill test
Time Frame
3 months
Title
maximal walking distance on treadmill test
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life assessment VascuQol-6
Time Frame
6 months
Title
Walking Impairment Questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria :
- Patient over 18 years old
Patient with claudication on PAD for more than 3 months
IPS (systolic pressure index) less than 0.90 at the level of the diseased limb
Absence of pathology limiting walk other than PAD
Patient having benefited from an arterial ultrasound of the lower limbs demonstrating arterial lesion
Absence of myocardial infarction over the last 6 months
Absence of cardiac pathology requiring surgery
Absence of angina
Patient affiliated or entitled to a social security system
Patient having given his free and written consent
exclusion criteria :
Patient who has not benefited from an arterial ultrasound of the lower limbs
All contraindications to treadmill events:
Myocardial infarction within the last 6 months
angina
Symptomatic tight aortic valve stenosis
Pathology limiting walk other than PAD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ambroise DUPREY
Phone
03 26 78 46 60
Ext
0033
Email
aduprey@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ambroise DUPREY
Phone
03 26 78 46 60
Ext
0033
Email
aduprey@chu-reims.fr
12. IPD Sharing Statement
Learn more about this trial
Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application
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