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

Katrin Paldán, Martin Steinmetz, Jan Simanovski, Christos Rammos, Greta Ullrich, Rolf Alexander Jánosi, Susanne Moebus, Tienush Rassaf, Julia Lortz, Katrin Paldán, Martin Steinmetz, Jan Simanovski, Christos Rammos, Greta Ullrich, Rolf Alexander Jánosi, Susanne Moebus, Tienush Rassaf, Julia Lortz

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://ichgcp.net/clinical-trials-registry/NCT04947228.

Keywords: artery; exercise; lifestyle; mHealth; mobile applications; motivation; peripheral arterial disease; supervised exercise therapy; well-being.

Conflict of interest statement

Conflicts of Interest: None declared.

©Katrin Paldán, Martin Steinmetz, Jan Simanovski, Christos Rammos, Greta Ullrich, Rolf Alexander Jánosi, Susanne Moebus, Tienush Rassaf, Julia Lortz. Originally published in JMIR mHealth and uHealth (https://mhealth.jmir.org), 16.08.2021.

Figures

Figure 1
Figure 1
Main views of the TrackPAD-app.
Figure 2
Figure 2
Quantitative development of screened patients including reasons for dropouts and exclusions.
Figure 3
Figure 3
Excerpt of results from the PAD-QoL questionnaire survey [21]. Shown are the mean deviations relative to the baseline (diamond) and the 25th and 75th percentiles (lines). Study (solid line) and control group (dotted line) are plotted separately. PAD: peripheral arterial disease.
Figure 4
Figure 4
Participants' statements regarding the trackPAD app in terms of functionality, aesthetics and information according to the user version of the Mobile Application Rating Scale [22].
Figure 5
Figure 5
App rating of the study group after study end according to the user version of the Mobile Application Rating Scale [22].

References

    1. Song P, Rudan D, Zhu Y, Fowkes FJI, Rahimi K, Fowkes FGR, Rudan I. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: An updated systematic review and analysis. The Lancet Global Health. 2019 Aug;7(8):e1020–e1030. doi: 10.1016/s2214-109x(19)30255-4.
    1. Bauersachs R, Zeymer U, Brière Jean-Baptiste, Marre C, Bowrin K, Huelsebeck M. Burden of coronary artery disease and peripheral artery disease: A literature review. Cardiovasc Ther. 2019;2019:8295054. doi: 10.1155/2019/8295054. doi: 10.1155/2019/8295054.
    1. Timmis A, Townsend N, Gale C, Torbica A, Lettino M, Petersen S. European Society of Cardiology: Cardiovascular disease statistics 2019. Eur Heart J. 2020. 2020;41(1):12–85. doi: 10.1093/ehjqcco/qcz065.
    1. Victor Aboyans, Jean-Baptiste Ricco, Marie-Louise E L Bartelink, Martin Björck, Marianne Brodmann, Tina Cohnert, Jean-Philippe Collet, Martin Czerny, Marco De Carlo. 2017 ESC Guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS) Russ J Cardiol. 2018 Sep 09;ESC Guidelines on the DiagnosisTreatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS)(8):164–221. doi: 10.15829/1560-4071-2018-8-164-221.
    1. Bouwens E, van Lier F, Rouwet EV, Verhagen HJM, Stolker RJ, Hoeks SE. Type D personality and health-related quality of life in vascular surgery patients. Int.J. Behav. Med. 2019 Jul 01;26(4):343–351. doi: 10.1007/s12529-018-09762-3.
    1. Harwood A, Smith GE, Cayton T, Broadbent E, Chetter IC. A systematic review of the uptake and adherence rates to supervised exercise programs in patients with intermittent claudication. Ann Vasc Surg. 2016 Jul;34:280–9. doi: 10.1016/j.avsg.2016.02.009.
    1. Abaraogu UO, Abaraogu OD, Dall PM, Tew G, Stuart W, Brittenden J, Seenan CA. Exercise therapy in routine management of peripheral arterial disease and intermittent claudication: a scoping review. Therapeutic Advances in Cardiovascular Disease. 2020 May 27;14:175394472092427. doi: 10.1177/1753944720924270.
    1. Rezvani F, Heider D, Härter Martin, König Hans-Helmut, Bienert F, Brinkmann J, Herbarth L, Kramer E, Steinisch P, Freudenstein F, Terhalle R, Grosse Y, Bock S, Posselt J, Beutel C, Reif F, Kirchhoff F, Neuschwander C, Löffler Franziska, Brunner L, Dickmeis P, Heidenthal T, Schmitz L, Chase DP, Seelenmeyer C, Alscher MD, Tegtbur U, Dirmaier J. Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation. BMJ Open. 2020 Jun 04;10(6):e032146. doi: 10.1136/bmjopen-2019-032146.
    1. Pedersen BK, Saltin B. Exercise as medicine: Evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec 25;25 Suppl 3:1–72. doi: 10.1111/sms.12581.
    1. Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 01;2(4):237–244. doi: 10.1093/ehjqcco/qcw018.
    1. Haveman ME, Kleiss SF, Ma KF, Vos CG, Ünlü Çağdaş, Schuurmann RC, Bokkers RP, Hermens HJ, De Vries JP. Telemedicine in patients with peripheral arterial disease: Is it worth the effort? Expert Rev Med Devices. 2019 Sep 05;16(9):777–786. doi: 10.1080/17434440.2019.1649595.
    1. Steinmetz M, Rammos C, Rassaf T, Lortz J. Digital interventions in the treatment of cardiovascular risk factors and atherosclerotic vascular disease. Int J Cardiol Heart Vasc. 2020 Feb;26:100470. doi: 10.1016/j.ijcha.2020.100470.
    1. Argent R, Daly A, Caulfield B. Patient involvement with home-based exercise programs: Can connected health interventions influence adherence? JMIR Mhealth Uhealth. 2018 Mar 01;6(3):e47. doi: 10.2196/mhealth.8518.
    1. McDermott M, Spring B, Berger J, Treat-Jacobson D, Conte M, Creager M. Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease: The HONOR randomized clinical trial. Journal of Vascular Surgery. 2018 Sep;68(3):933. doi: 10.1016/j.jvs.2018.07.014.
    1. Lortz J, Simanovski J, Kuether T, Kreitschmann-Andermahr I, Ullrich G, Steinmetz M, Rammos C, Jánosi Rolf Alexander, Moebus S, Rassaf T, Paldán Katrin. Needs and requirements in the designing of mobile interventions for patients with peripheral arterial disease: Questionnaire study. JMIR Form Res. 2020 Aug 04;4(8):e15669. doi: 10.2196/15669.
    1. Paldán Katrin, Simanovski J, Ullrich G, Steinmetz M, Rammos C, Jánosi Rolf Alexander, 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.
    1. ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 01;166(1):111–7. doi: 10.1164/ajrccm.166.1.at1102.
    1. Giannitsi S, Bougiakli M, Bechlioulis A, Kotsia A, Michalis LK, Naka KK. 6-minute walking test: a useful tool in the management of heart failure patients. Ther Adv Cardiovasc Dis. 2019 Aug 23;13:1753944719870084. doi: 10.1177/1753944719870084.
    1. Keteyian SJ, Patel M, Kraus WE, Brawner CA, McConnell TR, Piña Ileana L, Leifer ES, Fleg JL, Blackburn G, Fonarow GC, Chase PJ, Piner L, Vest M, O'Connor Christopher M, Ehrman JK, Walsh MN, Ewald G, Bensimhon D, Russell SD, HF-ACTION Investigators Variables measured during cardiopulmonary exercise testing as predictors of mortality in chronic systolic heart failure. J Am Coll Cardiol. 2016 Feb 23;67(7):780–9. doi: 10.1016/j.jacc.2015.11.050.
    1. Wegrzynowska-Teodorczyk K, Rudzinska E, Lazorczyk M, Nowakowska K, Banasiak W, Ponikowski P, Wozniewski M, Jankowska EA. Distance covered during a six-minute walk test predicts long-term cardiovascular mortality and hospitalisation rates in men with systolic heart failure: an observational study. Journal of Physiotherapy. 2013 Sep;59(3):177–187. doi: 10.1016/s1836-9553(13)70182-6.
    1. Andrianopoulos V, Wouters EF, Pinto-Plata VM, Vanfleteren LE, Bakke PS, Franssen FM, Agusti A, MacNee W, Rennard SI, Tal-Singer R, Vogiatzis I, Vestbo J, Celli BR, Spruit MA. Prognostic value of variables derived from the six-minute walk test in patients with COPD: Results from the ECLIPSE study. Respir Med. 2015 Sep;109(9):1138–46. doi: 10.1016/j.rmed.2015.06.013.
    1. Lamberti N, López-Soto Pablo Jesùs, Guerzoni F, Napoli N, Gasbarro V, Zamboni P, Tsolaki E, Taddia MC, Rodríguez-Borrego Maria Aurora, Manfredini R, Basaglia N, Manfredini F. Changes in exercise capacity and risk of all-cause mortality in patients with peripheral artery disease: a 10-year retrospective cohort study. Intern Emerg Med. 2020 Mar 21;15(2):289–298. doi: 10.1007/s11739-019-02176-3.
    1. McDermott MM, Kibbe MR, Guralnik JM, Ferrucci L, Criqui MH, Domanchuk K, Tian L, Zhao L, Li L, Patel K, Polonsky TS. Durability of benefits from supervised treadmill exercise in people with peripheral artery disease. JAHA. 2019 Jan 08;8(1):e009380. doi: 10.1161/jaha.118.009380.
    1. McDermott MM, Tian L, Criqui MH, Ferrucci L, Conte MS, Zhao L, Li L, Sufit R, Polonsky TS, Kibbe MR, Greenland P, Leeuwenburgh C, Guralnik JM. Meaningful change in 6-minute walk in people with peripheral artery disease. J Vasc Surg. 2021 Jan;73(1):267–276.e1. doi: 10.1016/j.jvs.2020.03.052.
    1. Hageman D, Fokkenrood H, Gommans L, van den Houten Marijn Ml, Teijink J. Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication. Cochrane Database Syst Rev. 2018 Apr 06;4:CD005263–131. doi: 10.1002/14651858.CD005263.pub4.
    1. McDermott MM. Exercise training for intermittent claudication. J Vasc Surg. 2017 Nov;66(5):1612–1620. doi: 10.1016/j.jvs.2017.05.111.
    1. Hotta K, Batchelor WB, Graven J, Dahya V, Noel TE, Ghai A, Katopodis JN, Dixon WC, Andrews R, Pragle A, Chheda J, Liberatore L, Behnke BJ, Muller-Delp J. Daily passive muscle stretching improves flow-mediated dilation of popliteal artery and 6-minute walk test in elderly patients with stable symptomatic peripheral artery disease. Cardiovasc Revasc Med. 2019 Aug;20(8):642–648. doi: 10.1016/j.carrev.2019.05.003.
    1. Treat-Jacobson D, Lindquist RA, Witt DR, Kirk LN, Schorr EN, Bronas UG, Davey CS, Regensteiner JG. The PADQOL: Development and validation of a PAD-specific quality of life questionnaire. Vasc Med. 2012 Nov 26;17(6):405–415. doi: 10.1177/1358863x12466708.
    1. Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and validation of the user version of the mobile application rating scale (uMARS) JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
    1. Saner H, van der Velde E. eHealth in cardiovascular medicine: A clinical update. Eur J Prev Cardiol. 2016 Oct 26;23(2 suppl):5–12. doi: 10.1177/2047487316670256.
    1. Kao C, Liebovitz DM. Consumer mobile health apps: Current state, barriers, and future directions. PM R. 2017 May 18;9(5S):S106–S115. doi: 10.1016/j.pmrj.2017.02.018.
    1. Miller David P, Weaver KE, Case LD, Babcock D, Lawler D, Denizard-Thompson N, Pignone MP, Spangler JG. Usability of a novel mobile health iPad app by vulnerable populations. JMIR Mhealth Uhealth. 2017 Apr 11;5(4):e43. doi: 10.2196/mhealth.7268.
    1. Geoghegan C, Nido V, Bemden AB, Hallinan Z, Jordan L, Kehoe LS, Morin SL, Niskar A, Okubagzi PG, Wood WA. Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials Commun. 2020 Sep;19:100636. doi: 10.1016/j.conctc.2020.100636.
    1. Karageorgos G, Andreadis I, Psychas K, Mourkousis G, Kiourti A, Lazzi G, Nikita KS. The promise of mobile technologies for the health care system in the developing world: a systematic review. IEEE Rev. Biomed. Eng. 2019;12:100–122. doi: 10.1109/rbme.2018.2868896.
    1. Guetterman TC, Sakakibara R, Baireddy S, Kron FW, Scerbo MW, Cleary JF, Fetters MD. Medical students' experiences and outcomes using a virtual human simulation to improve communication skills: Mixed methods study. J Med Internet Res. 2019 Nov 27;21(11):e15459. doi: 10.2196/15459.
    1. Williams JS, Walker RJ, Smalls BL, Hill R, Egede LE. Patient-centered care, glycemic control, diabetes self-care, and quality of life in adults with Type 2 diabetes. Diabetes Technol Ther. 2016 Oct;18(10):644–649. doi: 10.1089/dia.2016.0079.
    1. Quinn CC, Staub S, Barr E, Gruber-Baldini A. Mobile support for older adults and their caregivers: Dyad usability study. JMIR Aging. 2019 May 23;2(1):e12276. doi: 10.2196/12276.
    1. Haberlin C, O'Dwyer Tom, Mockler D, Moran J, O'Donnell Dearbhaile M, Broderick J. The use of eHealth to promote physical activity in cancer survivors: a systematic review. Support Care Cancer. 2018 Oct 16;26(10):3323–3336. doi: 10.1007/s00520-018-4305-z.
    1. van Houwelingen CT, Ettema RG, Antonietti MG, Kort HS. Understanding older people's readiness for receiving telehealth: Mixed-method study. J Med Internet Res. 2018 Apr 06;20(4):e123. doi: 10.2196/jmir.8407.
    1. Kruse C, Fohn J, Wilson N, Nunez Patlan E, Zipp S, Mileski M. Utilization barriers and medical outcomes commensurate with the use of telehealth among older adults: Systematic review. JMIR Med Inform. 2020 Aug 12;8(8):e20359. doi: 10.2196/20359.
    1. An H, Jones GC, Kang S, Welk GJ, Lee J. How valid are wearable physical activity trackers for measuring steps? Eur J Sport Sci. 2017 Apr 02;17(3):360–368. doi: 10.1080/17461391.2016.1255261.
    1. Leong JY, Wong JE. Accuracy of three Android-based pedometer applications in laboratory and free-living settings. J Sports Sci. 2017 Jan 07;35(1):14–21. doi: 10.1080/02640414.2016.1154592.
    1. Awais M, Mellone S, Chiari L. Physical activity classification meets daily life: Review on existing methodologies and open challenges. Proceedings of the 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC); 25–29 August 2015; Milan, Italy. Physical activity classification meets daily life: Review on existing methodologies and open challenges. Annu Int Conf IEEE Eng Med Biol Soc. 2015; 2015. pp. 5050–3.
    1. Wanner M, Richard A, Martin B, Faeh D, Rohrmann S. Associations between self-reported and objectively measured physical activity, sedentary behavior and overweight/obesity in NHANES 2003-2006. Int J Obes (Lond) 2017 Jan 28;41(1):186–193. doi: 10.1038/ijo.2016.168.
    1. Ball TJ, Joy EA, Gren LH, Shaw JM. Concurrent validity of a self-reported physical activity “vital sign” questionnaire with adult primary care patients. Prev. Chronic Dis. 2016 Feb 04;13:E16. doi: 10.5888/pcd13.150228.
    1. Yin K, Laranjo L, Tong HL, Lau AY, Kocaballi AB, Martin P, Vagholkar S, Coiera E. Context-aware systems for chronic disease patients: Scoping review. J Med Internet Res. 2019 Jun 17;21(6):e10896. doi: 10.2196/10896.
    1. Golledge J, Leicht AS, Yip L, Rowbotham SE, Pinchbeck J, Jenkins JS, Clapperton R, Dally-Watkins M, Fiatarone Singh MA, Mavros Y, Noble Y, Haghighi MM, Hollings M, Parmenter BJ, Burton NW. Relationship between disease specific quality of life measures, physical performance, and activity in people with intermittent claudication caused by peripheral artery disease. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):957–964. doi: 10.1016/j.ejvs.2020.02.006.
    1. Salisbury DL, Whipple MO, Burt M, Brown RJ, Hirsch A, Foley C, Treat-Jacobson D. Translation of an evidence-based therapeutic exercise program for patients with peripheral artery disease. J Vasc Nurs. 2018 Mar;36(1):23–33. doi: 10.1016/j.jvn.2017.09.003.
    1. Novakovic M, Jug B, Lenasi H. Clinical impact of exercise in patients with peripheral arterial disease. Vascular. 2017 Aug 09;25(4):412–422. doi: 10.1177/1708538116678752.

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