Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ROMTech Portable Connect.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass, Stable Angina. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Laboratory assessment [Time frame: Baseline, 12 weeks (End of Treatment)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- ROMTech — Brookfield
Identifiers
NCT: NCT05972070 · ROMTherapy_HBCR_1001