Cardiac Rehabilitation, Coronary Artery Bypass, Heart Failure, Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Stable Angina, Stent, Valve Disease, Heart
Conditions
Keywords
Cardiac rehabilitation, Home based cardiac rehabilitation, Telemedicine and Home-Based Cardiac Rehabilitation
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.
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
DEVICEROMTech 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.
Sponsors
ROM Technologies, INC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duke Activity Status Index (DASI) | Baseline, 12 weeks (End of Treatment) | Estimate of functional capacity |
| Session attended | 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) |
| Sessions completed | 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 |
| Short Form-36 | Baseline, 12 weeks (End of Treatment) | Quality of Life assessment |
| Patient Health Questionnaire(PHQ) | Baseline, 12 weeks (End of Treatment) | Quality of Life assessment |
| Short Physical Performance Battery | Baseline, 12 weeks (End of Treatment) | Lower extremity functional assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory assessment | Baseline, 12 weeks (End of Treatment) | To determine if there is an improvement in low density lipoprotein, triglycerides, |
Countries
United States
Contacts
Primary ContactLaToya T. King
Outcome results
None listed