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

NCT ID: NCT05972070

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myocardial Infarction Percutaneous Transluminal Coronary Angioplasty Coronary Artery Bypass Stable Angina Heart Failure Valve Disease, Heart Cardiac Rehabilitation Stent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac patients

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

ROMTech Portable Connect

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ROMTech PC ROMTech PortableConnect Rehab System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ROM Technologies, INC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ROMTech

Brookfield, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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LaToya T. King

Role: CONTACT

2035184735

Facility Contacts

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LaToya T King

Role: primary

203-518-4735

Other Identifiers

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ROMTherapy_HBCR_1001

Identifier Type: -

Identifier Source: org_study_id

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