Digital Support for Supervised Exercise Therapy in Peripheral Arterial Disease

NCT ID: NCT04947228

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2019-04-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intervention group

in addition to the usual therapy, the patients were given access to the trackPAD app

Group Type: EXPERIMENTAL

trackPAD

Intervention Type: DEVICE

TrackPAD is a smartphone app to provide PAD-specific support for SET

control group

patients in this group were treated as usual in the clinic without additional interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

trackPAD

TrackPAD is a smartphone app to provide PAD-specific support for SET

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Julia Lortz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Lortz

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Essen

Locations

Department of Cardiology and Vascular Medicine

Essen, , Germany

Countries

Germany

References

Paldan K, Simanovski J, Ullrich G, Steinmetz M, Rammos C, Janosi RA, Moebus S, Rassaf T, Lortz J. Feasibility and Clinical Relevance of a Mobile Intervention Using TrackPAD to Support Supervised Exercise Therapy in Patients With Peripheral Arterial Disease: Study Protocol for a Randomized Controlled Pilot Trial. JMIR Res Protoc. 2019 Jun 26;8(6):e13651. doi: 10.2196/13651.

Reference Type: BACKGROUND

PMID: 31244477 (View on PubMed)

Paldan K, Steinmetz M, Simanovski J, Rammos C, Ullrich G, Janosi RA, Moebus S, Rassaf T, Lortz J. Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 16;9(8):e24214. doi: 10.2196/24214.

Reference Type: DERIVED

PMID: 34398800 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

18-8355-BO

Identifier Type: -

Identifier Source: org_study_id