Trials / Recruiting
RecruitingNCT05972070
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- ROM Technologies, INC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Myocardial Infarction
- Percutaneous Transluminal Coronary Angioplasty
- Coronary Artery Bypass
- Stable Angina
- Heart Failure
- Valve Disease, Heart
- Cardiac Rehabilitation
- Stent
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2025-10-31
- Completion
- 2025-12-31
- First posted
- 2023-08-02
- Last updated
- 2025-07-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05972070. Inclusion in this directory is not an endorsement.