NCT05972070

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

2.4 years

First QC Date

July 3, 2023

Last Update Submit

July 21, 2025

Conditions

Myocardial InfarctionPercutaneous Transluminal Coronary AngioplastyCoronary Artery BypassStable AnginaHeart FailureValve Disease, HeartCardiac RehabilitationStent

Keywords

Cardiac rehabilitationHome based cardiac rehabilitationTelemedicine and Home-Based Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (6)

  • Session attended

    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

    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)

    Estimate of functional capacity

    Baseline, 12 weeks (End of Treatment)

  • Patient Health Questionnaire(PHQ)

    Quality of Life assessment

    Baseline, 12 weeks (End of Treatment)

  • Short Physical Performance Battery

    Lower extremity functional assessment

    Baseline, 12 weeks (End of Treatment)

  • Short Form-36

    Quality of Life assessment

    Baseline, 12 weeks (End of Treatment)

Secondary Outcomes (1)

  • Laboratory assessment

    Baseline, 12 weeks (End of Treatment)

Study Arms (1)

Cardiac patients

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

Device: ROMTech Portable Connect

Interventions

ROMTech Portable ConnectDEVICE

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.

Also known as: ROMTech PC, ROMTech PortableConnect Rehab System
Cardiac patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ROMTech

Brookfield, Connecticut, 06804, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Myocardial InfarctionAngina, StableHeart FailureHeart Valve Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

LaToya T. King

CONTACT

2035184735Latoya.King@romtech.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

August 2, 2023

Study Start

June 1, 2023

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations

US(1)