Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application (APAISE)

Home-based Exercice Therapy for Patients With Intermittent Claudication Using a New Smartphone Application : a Monocentric Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Intermittent Claudication
• Intervention / Treatment: Other: E-REVA® app; Other: No E-REVA® app

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ambroise DUPREY; Phone Number: 0033 03 26 78 46 60; Email: aduprey@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Ambroise DUPREY; Phone Number: 0033 03 26 78 46 60; Email: aduprey@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients randomized to using the smartphone app	Other: E-REVA® app; Use of a smartphone app designed for home-based exercise therapy of patients with intermittent claudication. App's name is E-REVA®.
Active Comparator: patients randomized to not using the smartphone app	Other: No E-REVA® app; No use smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
maximal walking distance on treadmill test	3 months
maximal walking distance on treadmill test	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life assessment VascuQol-6	6 months
Walking Impairment Questionnaire	6 months

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): May 19, 2028
• Study Completion (Estimated): May 19, 2028

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: peripheral arterial disease; Intermittent claudication; supervised exercise therapy; home-based exercise; smartphone medical application
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication
• Other Study ID Numbers: PA22075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No