An interventional study of HYCR and CBCR in Myocardial Infarction, Heart Failure and Heart Valve Diseases, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. This study will assess the efficacy of an innovative approach to CR delivery on attendance by combining both center-based and remote- or home-based CR sessions. The intervention group combines center-based CR and remote-/home-based CR and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine)
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 282 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR
Behavioral: HYCR
Behavioral: CBCR
This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a "willing to assist" family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.
This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care).
Time frame: Baseline to 6 months
Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program.
Outcome measure is the percent of people who complete all 36 CR sessions and the mean value reported represents the average percentage for all patients in both study groups.
Time frame: Baseline to 6 months
Improvement in Exercise Capacity, as Measured by Distance Walked During the Six Min Walk (6MW) Test, in Patients Randomized to HYCR vs Patients Randomized to CBCR.
Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).
Time frame: Baseline to 6 months
Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR.
Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).
Time frame: Baseline to 6 months
Improvement in Quality of Life (QOL), as Measured by the Total Score for Dartmouth COOP, in Patients Randomized to HYCR vs Patients Randomized to CBCR.
5-point Likert-type scaling, with 1 being more positive and 5 being more negative. Lower scores indicate higher levels of quality of life. Improvement in qualify of life was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).
Time frame: Baseline to 6 months
| Milestone | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Started | 142 | 140 |
| Completed | 81 | 78 |
| Not completed | 61 | 62 |
| Number of cardiac rehab sessions | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care). | 28.7 ± 11.8 | 27.6 ± 11.8 |
Outcome measure is the percent of people who complete all 36 CR sessions and the mean value reported represents the average percentage for all patients in both study groups.
| % of patients completing 36 sessions | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program. | 58.5 | 50.7 |
Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).
| Meters | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Improvement in Exercise Capacity, as Measured by Distance Walked During the Six Min Walk (6MW) Test, in Patients Randomized to HYCR vs Patients Randomized to CBCR. | 46 ± 46 | 50 ± 53 |
Improvement in exercise capacity was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).
| mL/kg/min | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR. | 2.3 ± 2.8 | 1.9 ± 2.8 |
5-point Likert-type scaling, with 1 being more positive and 5 being more negative. Lower scores indicate higher levels of quality of life. Improvement in qualify of life was calculated as the change in distance from the start of cardiac rehab (T1) and within 1 week after the last CR session of a patient or 6 months after completing T1 (whichever came first).
| units on a scale | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Improvement in Quality of Life (QOL), as Measured by the Total Score for Dartmouth COOP, in Patients Randomized to HYCR vs Patients Randomized to CBCR. | -3.9 ± 5.0 | -3.4 ± 5.3 |
Collected over 9-12 months, from the time patient enrolled into the study until they completed final study visit or 12 months from enrollment whichever came first.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hybrid Cardiac Rehabilitation (HYCR) | 1/142 (0.7%) | 1/142 (0.7%) | 8/142 (5.6%) |
| Center Based Cardiac Rehabilitation (CBCR) | 3/140 (2.1%) | 0/140 (0%) | 3/140 (2.1%) |
| Event | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| StrokeVascular disorders | 1/142 | 0/140 |
| Event | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) |
|---|---|---|
| Unstable AnginaCardiac disorders | 8/142 | 3/140 |
| Age, Categorical(Participants) | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 86 | 68 | 154 |
| >=65 years | 56 | 72 | 128 |
| Sex: Female, Male(Participants) | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) | Total |
|---|---|---|---|
| Female | 45 | 46 | 91 |
| Male | 97 | 94 | 191 |
| Race (NIH/OMB)(Participants) | Hybrid Cardiac Rehabilitation (HYCR) | Center Based Cardiac Rehabilitation (CBCR) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 76 | 76 | 152 |
| White | 62 | 59 | 121 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Henry Ford Health System