RecruitingNCT05972070

Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence


Sponsor

ROM Technologies, INC

Enrollment

500 participants

Start Date

Jun 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. Several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (MET's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. These tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Over the age of 18
  • NYHA Functional Class I, II,
  • Recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation)
  • Candidate for traditional center-based cardiac rehabilitation

Exclusion Criteria9

  • Under the age of 18
  • Adults lacking capacity to consent.
  • NYHA Functional Class III, IV
  • Acute coronary syndrome
  • Systolic heart failure (LV EF \<40%)
  • Status post cardiac surgery for structural heart disease or heart transplant
  • Percutaneous coronary angioplasty
  • Adults lacking capacity to consent.
  • Pregnant women

Interventions

DEVICEROMTech Portable Connect

The ROMTech PortableConnect Rehab System is a continuous rehabilitative exercise therapy device that uses assisted movement to measure, evaluate, exercise, re-educate and strengthen muscles, and to increase joint range of motion.


Locations(1)

ROMTech

Brookfield, Connecticut, United States

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NCT05972070


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