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

Last updated: July 21, 2025
Sponsor: ROM Technologies, INC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Occlusions

Circulation Disorders

Heart Failure

Treatment

ROMTech Portable Connect

Clinical Study ID

NCT05972070
ROMTherapy_HBCR_1001
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Over the age of 18

  2. NYHA Functional Class I, II,

  3. Recent (within 60 days) status post coronary artery revascularization foratherosclerotic coronary artery disease (coronary artery bypass grafting orpercutaneous coronary revascularization with stent implantation)

  4. Candidate for traditional center-based cardiac rehabilitation

Exclusion

Exclusion Criteria:

  1. Under the age of 18

  2. Adults lacking capacity to consent.

  3. NYHA Functional Class III, IV

  4. Acute coronary syndrome

  5. Systolic heart failure (LV EF <40%)

  6. Status post cardiac surgery for structural heart disease or heart transplant

  7. Percutaneous coronary angioplasty

  8. Adults lacking capacity to consent.

  9. Pregnant women

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: ROMTech Portable Connect
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2025

Study Description

The focus of this study is to determine the feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. The study consists of an initial review, rehabilitation sessions, nutrition consultation, and risk stratification. Once the patient is cleared for the rehabilitation program, they will be assigned a cardiac rehab specialist and begin the 36 rehabilitation sessions. The sessions include pre-session questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device exercises.

Connect with a study center

  • ROMTech

    Brookfield, Connecticut 06804
    United States

    Active - Recruiting

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