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

NCT05457738 | Recruiting

• 1 other identifier: PA22075
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Intermittent Claudication

Keywords

Intermittent claudication; peripheral arterial disease; supervised exercise therapy; home-based exercise; smartphone medical application

Outcome Measures

Primary Outcomes (2)

• maximal walking distance on treadmill test

  3 months

• maximal walking distance on treadmill test

  12 months

Secondary Outcomes (2)

• Quality of life assessment VascuQol-6

  6 months

• Walking Impairment Questionnaire

  6 months

Study Arms (2)

patients randomized to using the smartphone app

EXPERIMENTAL

Other: E-REVA® app

patients randomized to not using the smartphone app

ACTIVE COMPARATOR

Other: No E-REVA® app

Interventions

E-REVA® app OTHER

Use of a smartphone app designed for home-based exercise therapy of patients with intermittent claudication. App's name is E-REVA®.

patients randomized to using the smartphone app

No E-REVA® app OTHER

No use smartphone

patients randomized to not using the smartphone app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Ambroise DUPREY

CONTACT

03 26 78 46 60; aduprey@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 14, 2022
• Study Start: April 19, 2024
• Primary Completion (Estimated): May 19, 2028
• Study Completion (Estimated): May 19, 2028
• Last Updated: January 20, 2025

Record last verified: 2025-01

Locations

FR (1)