Home-based Walking Program With Smart Devices

NCT04113057 | Terminated

• 1 other identifier: 19-022
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Intermittent claudication (IC), the most common manifestation of peripheral artery disease (PAD), represents not only a significant detriment in quality of life, but also an increased risk for atherosclerotic cardiovascular disease (ASCVD), including progression of PAD, coronary artery disease (CAD) and cerebrovascular disease. Guideline directed therapy for IC includes supervised exercise, smoking cessation and optimal medical management to decrease overall risk of ASCVD. In the VA Health Care System, implementation of supervised exercise therapy through cardiac rehabilitation or physical therapy programs is limited by distances that patients must travel to VA facilities that provide these services. Furthermore, one of the most common failure points in exercise therapy programs is poor patient compliance. Improved patient participation and compliance in exercise programs for IC represents an unmet need, without which the majority of patients with life-style limiting PAD may not be receiving optimal medical management. Small studies have demonstrated the effectiveness of home-based exercise programs as an alternative to supervised exercise therapy; however, the success of the home-based exercise programs require remote coaching and/or regular provider feedback. The wide-spread availability of smart phones and smart devices has accelerated the implementation of telehealth programs that may supplement or may eventually replace in-person encounters for health care delivery. The role of provider feedback in addition to real-time feedback from smart devices remains completely unexplored. Our central hypothesis is that in individuals with IC, regular provider feedback on smart-device-based remote health monitoring data, which is available to the patient in real time, will augment the benefits of home-based exercise programs. We propose a randomized trial in patients with IC to test the central hypothesis through two Specific Aims:

1. 1.To determine the effect of provider feedback on smart-device-based remote health monitoring data during home-based exercise programs on walking distance in patients with IC.
2. 2.To determine the effect of provider feedback on smart-device-based remote health monitoring data during home-based exercise programs on quality of life (QOL) in patients with IC.

Conditions

PAD - Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Maximal walking distance

  Change in distance to claudication onset (e.g. pain in the legs that limits walking)

  Baseline to 12 weeks

Secondary Outcomes (2)

• Change in Quality of life measured by the VASCUQoL6

  Baseline to 12 weeks.

• Change in Quality of life measured by the WIQ Questionnaire

  Baseline to 12 weeks.

Study Arms (2)

Remote Coaching

EXPERIMENTAL

All subjects enrolled in the study will be enrolled in supervised exercise therapy. They will also receive directions for supplemental home-based exercise and a LIVMOR remote health monitoring system. The remote coaching arm will receive regular provider feedback based on LIVMOR data.

Other: Remote Coaching

Remote health monitoring without provider feedback

NO INTERVENTION

All subjects enrolled in the study will be enrolled in supervised exercise therapy. They will also receive directions for supplemental home-based exercise and a LIVMOR remote health monitoring system. The "no intervention" arm will have access to LIVMOR data, but without provider feedback on the LIVMOR data.

Interventions

Remote Coaching OTHER

In patients randomized to the remote coaching arm, study staff will provide feedback on home-based supplemental exercise based on heart rate and walking distance measurements from the LIVMOR health monitoring system.

Remote Coaching

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of documented PAD by ABI \<0.90 at rest or ≥20% drop in claudication limited exercise ABI in either limb and one of the following criteria in the corresponding limb:
• i. Prior lower extremity revascularization ii. Known presence of flow-limiting stenosis (≥70%) by clinically indicated angiography, computed tomographic (CT) or magnetic resonance imaging (MRI), or Duplex ultrasonography (DUS)
• Documented diagnosis of intermittent claudication
• Enrollment in supervised exercise therapy through the institutional cardiac rehab program

You may not qualify if:

• Severe cardiac or pulmonary disease that precludes participation in an exercise-based study.
• Severe psychiatric or behavioral illness that precludes study participation
• Inability to provide informed consent

Sponsors & Collaborators

• Dallas VA Medical Center: lead

Study Sites (1)

Dallas VAMC

Dallas, Texas, 75216, United States

Location

Related Publications (17)

• Banerjee S, Sarode K, Vinas A, Banerjee A, Mohammad A, Brilakis ES. The role of antiplatelet therapy in patients with peripheral artery disease and lower extremity peripheral artery revascularization. Curr Opin Cardiol. 2015 Sep;30(5):525-35. doi: 10.1097/HCO.0000000000000208.

  PMID: 26241710 BACKGROUND

• Bonaca MP, Scirica BM, Creager MA, Olin J, Bounameaux H, Dellborg M, Lamp JM, Murphy SA, Braunwald E, Morrow DA. Vorapaxar in patients with peripheral artery disease: results from TRA2degreesP-TIMI 50. Circulation. 2013 Apr 9;127(14):1522-9, 1529e1-6. doi: 10.1161/CIRCULATIONAHA.112.000679. Epub 2013 Mar 15.

  PMID: 23501976 BACKGROUND

• Conn NJ, Schwarz KQ, Borkholder DA. In-Home Cardiovascular Monitoring System for Heart Failure: Comparative Study. JMIR Mhealth Uhealth. 2019 Jan 18;7(1):e12419. doi: 10.2196/12419.

  PMID: 30664492 BACKGROUND

• Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.

  PMID: 25908725 BACKGROUND

• Fakhry F, van de Luijtgaarden KM, Bax L, den Hoed PT, Hunink MG, Rouwet EV, Spronk S. Supervised walking therapy in patients with intermittent claudication. J Vasc Surg. 2012 Oct;56(4):1132-42. doi: 10.1016/j.jvs.2012.04.046.

  PMID: 23026425 BACKGROUND

• Gardner AW, Parker DE, Montgomery PS, Blevins SM. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J Am Heart Assoc. 2014 Sep 18;3(5):e001107. doi: 10.1161/JAHA.114.001107.

  PMID: 25237048 BACKGROUND

• Gardner AW, Parker DE, Montgomery PS, Scott KJ, Blevins SM. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation. 2011 Feb 8;123(5):491-8. doi: 10.1161/CIRCULATIONAHA.110.963066. Epub 2011 Jan 24.

  PMID: 21262997 BACKGROUND

• Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):e71-e126. doi: 10.1016/j.jacc.2016.11.007. No abstract available.

  PMID: 27851992 BACKGROUND

• Hageman D, Fokkenrood HJ, Gommans LN, van den Houten MM, Teijink JA. Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication. Cochrane Database Syst Rev. 2018 Apr 6;4(4):CD005263. doi: 10.1002/14651858.CD005263.pub4.

  PMID: 29627967 BACKGROUND

• Harwood AE, Cayton T, Sarvanandan R, Lane R, Chetter I. A Review of the Potential Local Mechanisms by Which Exercise Improves Functional Outcomes in Intermittent Claudication. Ann Vasc Surg. 2016 Jan;30:312-20. doi: 10.1016/j.avsg.2015.05.043. Epub 2015 Sep 9.

  PMID: 26362620 BACKGROUND

• Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.

  PMID: 16549646 BACKGROUND

• McDermott MM. Exercise training for intermittent claudication. J Vasc Surg. 2017 Nov;66(5):1612-1620. doi: 10.1016/j.jvs.2017.05.111. Epub 2017 Sep 2.

  PMID: 28874320 BACKGROUND

• McDermott MM. Medical Management of Functional Impairment in Peripheral Artery Disease: A Review. Prog Cardiovasc Dis. 2018 Mar-Apr;60(6):586-592. doi: 10.1016/j.pcad.2018.03.007. Epub 2018 May 1.

  PMID: 29727608 BACKGROUND

• McDermott MM, Guralnik JM, Criqui MH, Ferrucci L, Zhao L, Liu K, Domanchuk K, Spring B, Tian L, Kibbe M, Liao Y, Lloyd Jones D, Rejeski WJ. Home-based walking exercise in peripheral artery disease: 12-month follow-up of the GOALS randomized trial. J Am Heart Assoc. 2014 May 21;3(3):e000711. doi: 10.1161/JAHA.113.000711.

  PMID: 24850615 BACKGROUND

• Montgomery PS, Gardner AW. The clinical utility of a six-minute walk test in peripheral arterial occlusive disease patients. J Am Geriatr Soc. 1998 Jun;46(6):706-11. doi: 10.1111/j.1532-5415.1998.tb03804.x.

  PMID: 9625185 BACKGROUND

• Sood A, Watts SA, Johnson JK, Hirth S, Aron DC. Telemedicine consultation for patients with diabetes mellitus: a cluster randomised controlled trial. J Telemed Telecare. 2018 Jul;24(6):385-391. doi: 10.1177/1357633X17704346. Epub 2017 Apr 13.

  PMID: 28406066 BACKGROUND

• Wang A. Review of vorapaxar for the prevention of atherothrombotic events. Expert Opin Pharmacother. 2015;16(16):2509-22. doi: 10.1517/14656566.2015.1099629. Epub 2015 Oct 19.

  PMID: 26480240 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: prospective randomized study

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 2, 2019
• Study Start: August 9, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)