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NCT Number: NCT05972070

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

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.

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Key information

Conditions

Myocardial Infarction Angina Pectoris Angina, Stable Cardiac Rehabilitation Cardiovascular Diseases Chest Pain Coronary Artery Bypass Heart Diseases Heart Failure Heart Valve Diseases Infarction Ischemia Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Transluminal Coronary Angioplasty STENT Signs and Symptoms Stable Angina Valve Disease, Heart Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ROMTech

Brookfield, Connecticut, 06804, United States

Location status: Recruiting

Location contact

John Stulak, MD

PRINCIPAL_INVESTIGATOR

LaToya T King

CONTACT

[email protected]

203-518-4735

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

ROMTech Portable Connect

Device

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.

Other names: ROMTech PC, ROMTech PortableConnect Rehab System

Primary outcomes

  1. Session attended

    Time frame: 12 weeks (End of treatment)

    Measure the number of sessions attended to determine the ease of patients to utilize home-based cardiac rehab integrated with telemedicine (non-inferiority to historical controls)

  2. Sessions completed

    Time frame: 12 weeks(End of treatment)

    Measure the number of sessions completed to determine compliance of patients to utilize home-based cardiac rehab integrated with telemedicine

  3. Duke Activity Status Index (DASI)

    Time frame: Baseline, 12 weeks (End of Treatment)

    Estimate of functional capacity

  4. Patient Health Questionnaire(PHQ)

    Time frame: Baseline, 12 weeks (End of Treatment)

    Quality of Life assessment

  5. Short Physical Performance Battery

    Time frame: Baseline, 12 weeks (End of Treatment)

    Lower extremity functional assessment

  6. Short Form-36

    Time frame: Baseline, 12 weeks (End of Treatment)

    Quality of Life assessment

Secondary outcomes

  1. Laboratory assessment

    Time frame: Baseline, 12 weeks (End of Treatment)

    To determine if there is an improvement in low density lipoprotein, triglycerides,

Study contacts

Contact information is provided by the study sponsor or research team.

LaToya T. King

CONTACT

[email protected]

2035184735

Sponsors and collaborators

Lead sponsor

ROM Technologies, INC

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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