Intermittent Claudication periheral arterial disease
Conditions
Interventions
A patient-centred mHealth smartphone app integrated with SET. The app enables
patients to conduct smartphone-guided home-training sessions and set goals and
monitor progress regarding walking capaci
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Diagnosis of intermittent claudication (symptomatic peripheral arterial disease, Rutherford stage 1-3, Fontaine 2a-2b) evidenced by a resting ankle-brachial index of *0.9 in rest and/or a drop of >0.15 after treadmill walking in either leg. - In possession of a smartphone capable of running the intervention application. - A signed informed consent form.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Supervised exercise therapy, performed in accordance with the guidelines of the Dutch Society of Physical Therapy, in the 12 months prior to study enrolment. - The ability to finish the Gardner Skinner treadmill test (i.e. walk for >30 minutes, or >1600 meters). - Severely limited ambulation due to a cause other than intermittent claudication (e.g. above or below the knee amputation, critical limb ischemia, wheelchair confinement, foot ulcer, significant visual impairment, unstable angina, heart failure NYHA class II or greater, COPD GOLD 3-4) and/or the inability to frequent the physical therapy centre at the expected visit frequency. - Deemed a poor candidate for inclusion at the discretion of the physical therapist or principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is usability and will be assessed through the system usability scale and semi-structured interviews. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the effect of the app on symptom severity (treadmill tests, six-minute walk test, vascular quality of life questionnaire 6, walking impairment questionnaire) and daily physical activity. The novel smartphone-based measurements of walking impairment will be assessed by determining their variability and test-retest reliability, agreement with conventional functional tests and patient-reported outcome measures, and response to 12 weeks of SET. | — |
Countries
Netherlands
Outcome results
None listed