PAD - Peripheral Arterial DiseaseNCT04113057
Home-based Walking Program With Smart Devices
A study testing Remote Coaching in people with PAD - Peripheral Arterial Disease, run by Dallas VA Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- PAD - Peripheral Arterial Disease
- What is being tested?
- Remote Coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Provider Feedback in Home-based Walking Programs Utilizing Smart Devices
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:
Read more
- 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.
- 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.
Based on a sample size calculation to detect a 50% increase in walking distance between the 2 groups, we expect to enroll 30 patients (15 in each group). Patient participation in the study will be concluded after 12 weeks.
As an exploratory aim in the study, we will also (as an optional part of the study) collect plasma before and after the 12-weeks of exercise to investigate changes in lipid levels and plasma biomarkers associated with exercise therapy. This exploratory aim will generate preliminary data for future studies.
Read the detailed description
The study design is that of a prospective randomized study of patients presenting to the vascular surgery and cardiology clinics with symptoms of IC and enrolled in 12-week supervised exercise program. Upon enrollment, each patient will undergo a medical and surgical history, ascertainment of smoking status, review of medications, and 6-minute walk test (walking on a flat, pre-defined course(i.e. hallway) for 6 minutes and recording time and distance to claudication onset as well as total distance walked, and total number of steps taken). We will also collect data from the patient's CPRS notes through our institutional cardiac rehab/PAD rehab program, with a dedicated cardiac rehab nurse. Patients with IC who are enrolled in the study will also be asked to complete 2 QOL questionnaires: the VASCUQoL6 and the Walking Impairment Questionnaire (WIQ). Patients will undergo supervised exercise therapy (per cardiac rehab protocol) and will receive the LIVMOR health monitoring system with instructions on how to use it. Randomization and details of exercise therapy are described in the next section. Patients will be followed for up to 12 weeks to collect data regarding change in distance and time of claudication onset.
In the optional exploratory aim, we will analyze plasma from one blood draw at the beginning and at the end of exercise therapy for lipid levels, distribution of LDL particle size, and other biomarkers. We will perform metabolomics, proteomics, and lipidomics assays to examine small circulating molecules that are involved in the development of atherosclerotic plaque in peripheral arterial disease. All blood and plasma analysis performed outside of Pathology and the Clinical Core Lab will be performed in the PI's research laboratory at the Dallas VA Medical Center by members of the research staff, or by members of the PI's collaborating lab at UT Southwestern or in the UT Southwestern research Core Laboratories. Any plasma sent to UT Southwestern will be de-identified.
Data (including name, birth date, social security number, dates of procedures and studies) will be stored in an Excel spreadsheet. Each patient's data will be associated with a study ID and stripped of the 18 identifiers need to de-identify the data. Only study staff will have access to PHI. No PHI will be released outside the North Texas VA Health Care Systems.
For the LIVMOR system, only the patient's study ID will be entered into the system. De-identified health monitoring data (heart rate, steps taken, distance walked) will be transmitted and stored in the LIVMOR cloud server, as was done in the LIVMOR Data Collection Study (IRB# 17-106).
After enrollment, baseline data, including questionnaires, will be collected. Patients who have agreed to optional blood draw will have a fasting blood draw (up to 10 cc) at the next available time within 1 week of study enrollment. At the next supervised exercise therapy visit (occurs 3 times a week according to the cardiac rehab protocol), the patient will have baseline resting heart rate and blood pressure measurements, and will undergo a 6-minute walk test. The patient will be randomized to remote coaching (regular provider feedback based on LIVMOR data) vs. remote health monitoring without provider feedback. Each patient will be sent home with instructions for home-based supplemental exercise and a LIVMOR remote health monitoring system, which includes a wristwatch that records heart rate, steps taken, and distance traveled (pedometer function) and a tablet. Patients will be instructed to check a resting heart rate with the LIVMOR watch for 10 minutes before starting exercise. They will exercise while wearing the watch (heart rate monitor and pedometer), then check heart rate for 10 minutes after completion of the exercise session. Patients will not receive real time feedback from the smart-watch heart rate monitor, however they have the option to review their heart rate and pedometer data by logging into the tablet provided with the watch, after the exercise session. In patients randomized to the remote coaching arm, study staff will provide feedback on home-based supplemental exercise based on heart rate measurements and pedometer measurements from the LIVMOR health monitoring system, as well as heart rate and walking data collected from supervised exercise therapy sessions. Remote coaching will occur by telephone call, but the conversation will mirror conversations that occur during supervised exercise therapy, and will not be based solely on the surrogate measure of heart rate for walking effort. A member of the study team will call the patient 1-3 times a week, depending on the patient's preference, which may change over the course of the study. Therefore the remote coaching is adaptive to patient's needs. In patients randomized to no remote coaching, health monitoring data will be reviewed by study staff, but will not be used to adjust home-based supplemental exercise. Any abnormalities in health monitoring data will be alerted to appropriate clinical staff. All patients will keep a journal of their home-based supplemental exercise, including time of exercise, in order to correlate heart rate readings from the smart-watch.
For patients agreeing to the optional blood draw: Blood will be sent to the Dallas VA Medical Center clinical lab for a lipid panel. The remaining blood will be refrigerated, then transported to the PI's research lab at the Dallas VA Medical Center, where the research staff will centrifuge the blood to isolate plasma.
Plasma will be tested for the following:
- Metabolomics, proteomics, and lipidomics assays to study small circulating molecules that may be involved in the development of atherosclerosis in peripheral arterial disease, and may change with exercise therapy.
- Lipoprotein subfractions.
- Small molecules that can be assayed using ELISA. At the end of the 12-week program, an end-of-study 6 minute walk test will be performed as well as the questionnaires will be completed. All the LIVMOR devices will be returned to the investigators. If the patient is unable to complete the end-of study 6-min walk test or does not complete the 12-week exercise program, a phone follow- up will be done to complete the questionnaires. A final blood draw will be completed (within 1 week of completing the 12-week exercise program) for patients who have opted for the blood draw.
The LIVMOR system transmits data through wireless technology up to a cloud server. The data transmission is encrypted and FIPS-140-2 compliant.
- Conditions
- PAD - Peripheral Arterial Disease
- Being tested
- Remote Coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote CoachingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal walking distance
Change in distance to claudication onset (e.g. pain in the legs that limits walking)
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change in Quality of life measured by the VASCUQoL6
Change in quality of life as measured by the VASCUQoL6 Questionnaire
Measured: Baseline to 12 weeks.
Change in Quality of life measured by the WIQ Questionnaire
Change in quality of life as measured by the WIQ Questionnaire
Measured: Baseline to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start9 Aug 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Why it stopped: In-person supervised exercise therapy (SET) at this institution, a required component of this study, was halted during Covid19 and was not re-instated after clinical activities resumed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Shirling Tsai, Dallas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113057
- Sponsor's protocol ID
- 19-022
- Status last verified
- Nov 2021
- First submitted
- 26 Sep 2019
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
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.
PubMed 26241710Bonaca 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.
PubMed 23501976Conn 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.
PubMed 30664492Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
PubMed 25908725Fakhry 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.
PubMed 23026425Gardner 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.
PubMed 25237048Gardner 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.
PubMed 21262997Gerhard-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.
PubMed 27851992Hageman 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.
PubMed 29627967Harwood 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.
PubMed 26362620Hirsch 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.
PubMed 16549646McDermott 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.
PubMed 28874320McDermott 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.
PubMed 29727608McDermott 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.
PubMed 24850615Montgomery 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.
PubMed 9625185
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Provider Feedback in Home-based Walking Programs Utilizing Smart Devices
- ClinicalTrials.gov ID
- NCT04113057
- Acronym / sponsor ID
- 19-022
- Conditions
- PAD - Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In-person supervised exercise therapy (SET) at this institution, a required component of this study, was halted during Covid19 and was not re-instated after clinical activities resumed.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Based on a sample size calculation to detect a 50% increase in walking distance between the 2 groups, we expect to enroll 30 patients (15 in each group). Patient participation in the study will be concluded after 12 weeks.
As an exploratory aim in the study, we will also (as an optional part of the study) collect plasma before and after the 12-weeks of exercise to investigate changes in lipid levels and plasma biomarkers associated with exercise therapy. This exploratory aim will generate preliminary data for future studies.
Detailed description
The study design is that of a prospective randomized study of patients presenting to the vascular surgery and cardiology clinics with symptoms of IC and enrolled in 12-week supervised exercise program. Upon enrollment, each patient will undergo a medical and surgical history, ascertainment of smoking status, review of medications, and 6-minute walk test (walking on a flat, pre-defined course(i.e. hallway) for 6 minutes and recording time and distance to claudication onset as well as total distance walked, and total number of steps taken). We will also collect data from the patient's CPRS notes through our institutional cardiac rehab/PAD rehab program, with a dedicated cardiac rehab nurse. Patients with IC who are enrolled in the study will also be asked to complete 2 QOL questionnaires: the VASCUQoL6 and the Walking Impairment Questionnaire (WIQ). Patients will undergo supervised exercise therapy (per cardiac rehab protocol) and will receive the LIVMOR health monitoring system with instructions on how to use it. Randomization and details of exercise therapy are described in the next section. Patients will be followed for up to 12 weeks to collect data regarding change in distance and time of claudication onset.
In the optional exploratory aim, we will analyze plasma from one blood draw at the beginning and at the end of exercise therapy for lipid levels, distribution of LDL particle size, and other biomarkers. We will perform metabolomics, proteomics, and lipidomics assays to examine small circulating molecules that are involved in the development of atherosclerotic plaque in peripheral arterial disease. All blood and plasma analysis performed outside of Pathology and the Clinical Core Lab will be performed in the PI's research laboratory at the Dallas VA Medical Center by members of the research staff, or by members of the PI's collaborating lab at UT Southwestern or in the UT Southwestern research Core Laboratories. Any plasma sent to UT Southwestern will be de-identified.
Data (including name, birth date, social security number, dates of procedures and studies) will be stored in an Excel spreadsheet. Each patient's data will be associated with a study ID and stripped of the 18 identifiers need to de-identify the data. Only study staff will have access to PHI. No PHI will be released outside the North Texas VA Health Care Systems.
For the LIVMOR system, only the patient's study ID will be entered into the system. De-identified health monitoring data (heart rate, steps taken, distance walked) will be transmitted and stored in the LIVMOR cloud server, as was done in the LIVMOR Data Collection Study (IRB# 17-106).
After enrollment, baseline data, including questionnaires, will be collected. Patients who have agreed to optional blood draw will have a fasting blood draw (up to 10 cc) at the next available time within 1 week of study enrollment. At the next supervised exercise therapy visit (occurs 3 times a week according to the cardiac rehab protocol), the patient will have baseline resting heart rate and blood pressure measurements, and will undergo a 6-minute walk test. The patient will be randomized to remote coaching (regular provider feedback based on LIVMOR data) vs. remote health monitoring without provider feedback. Each patient will be sent home with instructions for home-based supplemental exercise and a LIVMOR remote health monitoring system, which includes a wristwatch that records heart rate, steps taken, and distance traveled (pedometer function) and a tablet. Patients will be instructed to check a resting heart rate with the LIVMOR watch for 10 minutes before starting exercise. They will exercise while wearing the watch (heart rate monitor and pedometer), then check heart rate for 10 minutes after completion of the exercise session. Patients will not receive real time feedback from the smart-watch heart rate monitor, however they have the option to review their heart rate and pedometer data by logging into the tablet provided with the watch, after the exercise session. In patients randomized to the remote coaching arm, study staff will provide feedback on home-based supplemental exercise based on heart rate measurements and pedometer measurements from the LIVMOR health monitoring system, as well as heart rate and walking data collected from supervised exercise therapy sessions. Remote coaching will occur by telephone call, but the conversation will mirror conversations that occur during supervised exercise therapy, and will not be based solely on the surrogate measure of heart rate for walking effort. A member of the study team will call the patient 1-3 times a week, depending on the patient's preference, which may change over the course of the study. Therefore the remote coaching is adaptive to patient's needs. In patients randomized to no remote coaching, health monitoring data will be reviewed by study staff, but will not be used to adjust home-based supplemental exercise. Any abnormalities in health monitoring data will be alerted to appropriate clinical staff. All patients will keep a journal of their home-based supplemental exercise, including time of exercise, in order to correlate heart rate readings from the smart-watch.
For patients agreeing to the optional blood draw: Blood will be sent to the Dallas VA Medical Center clinical lab for a lipid panel. The remaining blood will be refrigerated, then transported to the PI's research lab at the Dallas VA Medical Center, where the research staff will centrifuge the blood to isolate plasma.
Plasma will be tested for the following:
- Metabolomics, proteomics, and lipidomics assays to study small circulating molecules that may be involved in the development of atherosclerosis in peripheral arterial disease, and may change with exercise therapy.
- Lipoprotein subfractions.
- Small molecules that can be assayed using ELISA. At the end of the 12-week program, an end-of-study 6 minute walk test will be performed as well as the questionnaires will be completed. All the LIVMOR devices will be returned to the investigators. If the patient is unable to complete the end-of study 6-min walk test or does not complete the 12-week exercise program, a phone follow- up will be done to complete the questionnaires. A final blood draw will be completed (within 1 week of completing the 12-week exercise program) for patients who have opted for the blood draw.
The LIVMOR system transmits data through wireless technology up to a cloud server. The data transmission is encrypted and FIPS-140-2 compliant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Remote Coaching | Experimental | Other: Remote CoachingAll 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
- Documented diagnosis of intermittent claudication
- Enrollment in supervised exercise therapy through the institutional cardiac rehab program
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote CoachingIn 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. | Other | Remote Coaching |
Primary outcome
Maximal walking distance
Time frame: Baseline to 12 weeks
Change in distance to claudication onset (e.g. pain in the legs that limits walking)
2 secondary outcomes
Change in Quality of life measured by the VASCUQoL6
Time frame: Baseline to 12 weeks.
Change in Quality of life measured by the WIQ Questionnaire
Time frame: Baseline to 12 weeks.
Results and safety
The study was stopped early (reason given: In-person supervised exercise therapy (SET) at this institution, a required component of this study, was halted during Covid19 and was not re-instated after clinical activities resumed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Background: PubMed 26241710Banerjee 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.
- Background: PubMed 23501976Bonaca 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.
- Background: PubMed 30664492Conn 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.
- Background: PubMed 25908725Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.
- Background: PubMed 23026425Fakhry 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.
- Background: PubMed 25237048Gardner 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.
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- Background: PubMed 27851992Gerhard-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.
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- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Coaching in people with PAD - Peripheral Arterial Disease, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: In-person supervised exercise therapy (SET) at this institution, a required component of this study, was halted during Covid19 and was not re-instated after clinical activities resumed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal walking distance (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04113057, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.