Digital Support for Supervised Exercise Therapy in Peripheral Arterial Disease

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: trackPAD

• Registration Number: NCT04947228
• Lead Sponsor: University Hospital, Essen

Brief Summary

The individual restrictions of daily life for patients with PAD are more important than statistical facts for mortality and morbidity. Intermittent claudication causes a progressive reduction of the pain-free walking distance (PWD) as an expression of a worsening PAD. This decrease in physical capability results in a decline of mental health and relevantly reduces the patients' quality of life (QoL).

Supervised exercise therapy (SET) is a cornerstone in the conservative management of intermittent claudication and extends the PWD. Even though SET is easy to practice and highly cost effective, the adherence to perform SET on a regular base is rather low. The underuse of exercise can be partly explained by the lack of institutional resources, but also by both patients' and physicians' lack of interest in exercise.

Mobile health (mHealth) technologies increase the incentives and provide digital support for patients with PAD on several treatment levels. They might lead to a higher adherence to exercise training and offer new scopes in patient-centered healthcare, but so far studies show opposite results. Because app stores are flooded with health and fitness apps, specific support tools are highly desired by patients with PAD and PAD-specific solutions are missing so far. Based on this background, the investigators developed a smartphone app named TrackPAD to provide PAD-specific support for SET.

The TrackPAD pilot study was designed as a 2-armed randomized controlled trial and included patients with diagnosed and symptomatic PAD. Patients were randomized by the Center for Clinical Studies in Essen using the TENALEA software into 2 groups. The control group included participants with standard care and no further mobile intervention. The intervention group included participants with standard care and additional mHealth-based self-tracking of their physical activity using trackPAD.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-06
• Primary Completion: 2019-03-28
• Study Completion: 2019-04-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-23
• Last Update Submitted: 2021-06-23
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of lower extremity PAD based on (and/or):

  • ABI ≤ 0.9 in at least one legs
  • Invasive or non-invasive imaging of stenotic lower extremity artery disease
  • Endovascular or surgical revascularization of lower extremity artery

• PAD Fontaine Stage IIa/b

• Smartphone with possibility to use TrackPAD: Android ≥ 5.0 or IOS ≥ 11.0

• Written informed consent prior to any study procedures, including a specified follow-up evaluation

• Best-medical treatment in the last 2 months in accordance with standard guidelines

Exclusion Criteria

• Wheelchair bound, use of walking aid or walking impairment due to another cause than PAD
• Below or above knee amputation
• Acute or critical limb ischemia
• PAD Fontaine Stage I or III / IV
• No German knowledge
• Severe cognitive dysfunction
• Congestive heart failure with NYHA III-IV symptoms
• Active congestive heart failure requiring the initiation or uptitration of diuretic therapy
• Angina pectoris with CCS class 3-4 symptoms or myocardial infarction or stroke in the last 3 months
• Active arrhythmia requiring the initiation or uptitration of anti-arrhythmic therapy
• Severe valve disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	trackPAD	in addition to the usual therapy, the patients were given access to the trackPAD app

Primary Outcome Measures

Name	Time	Method
change in 6-minutes walking distance	baseline, 3 months follow-up	measured via GPS with the trackPAD app

Secondary Outcome Measures

Name	Time	Method
peripheral arterial disease-related quality of life	baseline, 3 months follow-up	measured with the Peripheral artery disease Quality of Life Questionnaire (PADQOL) questionnaire, a validated PAD-specific questionnaire. Minimum score is 38 and maximum is 228, with higher values indicating a better outcome.
change in physical activity, measured in patients' self-report on how many days a week on average they engage in a physical activity that causes them to sweat or get out of breath, and how many minutes on average they spend doing it.	baseline, 3 months follow-up	to compare the two groups groups in terms of physical endurance, the self-reported physical activity was recorded
Usability of the TrackPAD app	baseline, 3 months follow-up	measured with the User version of the Mobile Application Rating Scale (uMars) questionnaire. The uMARS includes 3 factors, namely app quality, app subjective quality and perceived impact. Minimum score of the app quality scale is 4 and the maximum is 20. The App Subjective Quality scale has a minimum of 4 and a maximum of 20, and the Perceived Impact scale has a minimum of 6 and a maximum of 30. Higher values indicate a better outcome.

Trial Locations

Locations (1)

Department of Cardiology and Vascular Medicine; 🇩🇪 Essen, Germany