Recruiting

Telemedicine Integration

Sponsor:

ROM Technologies, INC

Code:

NCT05972070

Conditions

Myocardial Infarction

Percutaneous Transluminal Coronary Angioplasty

Coronary Artery Bypass

Stable Angina

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ROMTech Portable Connect

Study Details

Brief 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.

Conditions

Myocardial Infarction

Percutaneous Transluminal Coronary Angioplasty

Coronary Artery Bypass

Stable Angina

Heart Failure

Study ID

NCT05972070

Start date

Jun 1, 2023

Status verified date

Jul, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac patients

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

Interventions

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.

Primary outcome measure

  • Session attended [ Time Frame: 12 weeks (End of treatment) ]
  • Sessions completed [ Time Frame: 12 weeks(End of treatment) ]
  • Duke Activity Status Index (DASI) [ Time Frame: Baseline, 12 weeks (End of Treatment) ]
  • Patient Health Questionnaire(PHQ) [ Time Frame: Baseline, 12 weeks (End of Treatment) ]
  • Short Physical Performance Battery [ Time Frame: Baseline, 12 weeks (End of Treatment) ]
  • Short Form-36 [ Time Frame: Baseline, 12 weeks (End of Treatment) ]

Central Contacts and Locations

Central contacts

LaToya T. King

2035184735Latoya.King@romtech.com

Locations

ROMTech

Recruiting

Brookfield, Connecticut, United States, 06804

Contacts

LaToya T King

203-518-4735Latoya.King@romtech.com

Principal Investigator:

John Stulak, MD

More Information

Sponsor

ROM Technologies, INC

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • Cardiac rehabilitation
  • Home based cardiac rehabilitation
  • Telemedicine and Home-Based Cardiac Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ROM Technologies, INC on 2025-07-24.