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RecruitingNCT05457738APAISEUpdated Jan 20, 2025

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

An interventional study of E-REVA® app and No E-REVA® app in Intermittent Claudication, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-20.

Sponsored by CHU de Reims · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intermittent Claudication

Keywords

  • Intermittent claudication
  • peripheral arterial disease
  • supervised exercise therapy
  • home-based exercise
  • smartphone medical application
03

In context

Intermittent Claudication

309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.

This study's planned enrollment of 52 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.

Browse Intermittent Claudication studies →

Lead sponsor

CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

exclusion criteria :

  • Patient who has not benefited from an arterial ultrasound of the lower limbs
  • All to treadmill events:

    • Myocardial infarction within the last 6 months
    • angina
    • Symptomatic tight aortic valve stenosis
    • Pathology limiting walk other than PAD
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    patients randomized to using the smartphone app

    Other: E-REVA® app

  • Active comparator
    patients randomized to not using the smartphone app

    Other: No E-REVA® app

Interventions

  • OtherE-REVA® app

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

  • OtherNo E-REVA® app

    No use smartphone

06

What researchers measure

Primary outcomes

  1. maximal walking distance on treadmill test

    Time frame: 3 months

  2. maximal walking distance on treadmill test

    Time frame: 12 months

Secondary outcomes

  1. Quality of life assessment VascuQol-6

    Time frame: 6 months

  2. Walking Impairment Questionnaire

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05457738
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Jul 14, 2022
Start date
Apr 19, 2024
Primary completion
May 19, 2028 (estimated)
Completion
May 19, 2028 (estimated)
Last update
Jan 20, 2025

Study contacts

Ambroise DUPREY
Contact
aduprey@chu-reims.fr
03 26 78 46 60 ext. 0033

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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