Supervised Exercise Therapy Using Mobile Health Technology in Patients With Peripheral Arterial Disease: Pilot Randomized Controlled Trial

Abstract

Background Mobile health interventions are intended to support complex health care needs in chronic diseases digitally, but they are mainly targeted at general health improvement and neglect disease-specific requirements. Therefore, we designed TrackPAD, a smartphone app to support supervised exercise training in patients with peripheral arterial disease. Objective This pilot study aimed to evaluate changes in the 6-minute walking distance (meters) as a primary outcome measure. The secondary outcome measures included changes in physical activity and assessing the patients’ peripheral arterial disease–related quality of life. Methods This was a pilot two-arm, single-blinded, randomized controlled trial. Patients with symptomatic PAD (Fontaine stage IIa/b) and access to smartphones were eligible. Eligible participants were randomly assigned to the study, with the control group stratified by the distance covered in the 6-minute walking test using the TENALEA software. Participants randomized to the intervention group received usual care and the mobile intervention (TrackPAD) for the follow-up period of 3 months, whereas participants randomized to the control group received routine care only. TrackPAD records the frequency and duration of training sessions and pain levels using manual user input. Clinical outcome data were collected at the baseline and after 3 months via validated tools (the 6-minute walk test and self-reported quality of life). The usability and quality of the app were determined using the Mobile Application Rating Scale user version. Results The intervention group (n=19) increased their mean 6-minute walking distance (83 meters, SD 72.2), while the control group (n=20) decreased their mean distance after 3 months of follow-up (–38.8 meters, SD 53.7; P=.01). The peripheral arterial disease–related quality of life increased significantly in terms of “symptom perception” and “limitations in physical functioning.” Users’ feedback showed increased motivation and a changed attitude toward performing supervised exercise training. Conclusions Besides the rating providing a valuable support tool for the user group, the mobile intervention TrackPAD was linked to a change in prognosis-relevant outcome measures combined with enhanced coping with the disease. The influence of mobile interventions on long-term prognosis must be evaluated in the future. Trial Registration ClinicalTrials.gov NCT04947228; https://clinicaltrials.gov/ct2/show/NCT04947228

A Systematic Review of Personalized Health Applications through Human–Computer Interactions (HCI) on Cardiovascular Health Optimization

“…There were different tools used to measure physical activity for these studies. One study used the 6-minute walk test, [ 13 ] an abridged 12-item version of the Intrinsic Motivation Inventory [ 12 ], and daily step count [ 10 ]. For instance, Martin et al [ 10 ] observed that the population that received text message reminders walked close to 2534 daily steps more than those who did not get the text messages reminders (95% CI: 1318–3750; p < 0.001).…”

“…The studies were studies published between 2011 and 2021. Two of the studies were conducted in the U.S.A [ 10 , 11 ] and two in Finland [ 12 , 13 ], and the rest we conducted per region including India [ 14 ], Belgium [ 15 ], China [ 16 ], Spain [ 17 ], China and India [ 18 ] combined, and finally the Kaiser Permanente health plan regions (Northwest, Hawaii, and Georgia) [ 19 ]. The longest study duration was 12 months.…”

“…Some of the mHealth interventions even included smartphone games as a model to facilitate behavioral change to motivate physical activity for enhanced cardiovascular disease treatment outcomes. In one particular study, Paldán et al [ 13 ] discussed one of the mHealth mobile intervention software (TrackPAD) called TENALEA used to motivate and monitor walking through step counting to enhance the quality of life of peripheral arterial disease patients. The other technology-based tools like the Interactive voice recognition calls (IVR regular and IVR advanced) used in conjunction with EMR were also discussed.…”

Telemedicine and Digital Health Applications in Vascular Surgery

“…There is a growing interest to use telemedicine as an innovative tool to enhance both supervised and home-based exercise programs, with the development of wearable activity monitors and applications to enhance education and patients’ adherence [ 57 , 58 , 59 , 60 , 61 ]. Several reviews and systematic analyses provided an overview of randomized controlled clinical trials that aimed at investigating the efficiency of telemedicine-enhanced exercise programs on patients’ outcomes [ 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 , 73 ] ( Table 1 ).…”

“…Telemedicine applications used varied and included telemonitoring with wearable sensors and physical activity trackers [ 62 , 63 , 64 , 67 , 68 ], as well as telecoaching applications using smart technology (computers or mobile phones) [ 65 , 66 , 69 , 73 ]. The clinical trials included symptomatic patients with intermittent claudication; one study also involved patients who had previously received peripheral endovascular therapy [ 65 ] and one involved asymptomatic patients with LEAD [ 68 ].…”