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

July 21, 2025 updated by: ROM Technologies, INC
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Brookfield, Connecticut, United States, 06804
        • Recruiting
        • ROMTech
        • Contact:
        • Principal Investigator:
          • John Stulak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.

Description

Inclusion Criteria:

  1. Over the age of 18
  2. NYHA Functional Class I, II,
  3. 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)
  4. Candidate for traditional center-based cardiac rehabilitation

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac patients
Adult patients who have undergone surgical or percutaneous coronary revascularization due to atherosclerotic coronary artery disease.
Device: ROMTech 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.
Other Names:
  • ROMTech PC
  • ROMTech PortableConnect Rehab System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks (End of treatment)
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
12 weeks(End of treatment)
Duke Activity Status Index (DASI)
Time Frame: Baseline, 12 weeks (End of Treatment)
Estimate of functional capacity
Baseline, 12 weeks (End of Treatment)
Patient Health Questionnaire(PHQ)
Time Frame: Baseline, 12 weeks (End of Treatment)
Quality of Life assessment
Baseline, 12 weeks (End of Treatment)
Short Physical Performance Battery
Time Frame: Baseline, 12 weeks (End of Treatment)
Lower extremity functional assessment
Baseline, 12 weeks (End of Treatment)
Short Form-36
Time Frame: Baseline, 12 weeks (End of Treatment)
Quality of Life assessment
Baseline, 12 weeks (End of Treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laboratory assessment
Time Frame: Baseline, 12 weeks (End of Treatment)
To determine if there is an improvement in low density lipoprotein, triglycerides,
Baseline, 12 weeks (End of Treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ROM Technologies, INC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROMTherapy_HBCR_1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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