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The goal of this trial is to assess the medium- (6 months) and long-term (12 months) effects of a Home-Based exercise program after in-Hospital comprehensive Cardiac Rehabilitation (CR) - as compared with usual care - on exercise capacity, health-related quality of life and health care services utilization, in patients (pts) older than 75 years after recent acute coronary syndromes or cardiac surgery.
Data on the short-term efficacy of comprehensive CR are still limited in older pts with cardiovascular disease, and no information is available on maintenance of results achieved with CR over the medium- and long-term periods. As long-term adherence with exercise programs after comprehensive CR is generally poor, with only 30% reporting regular exercise at 12-month follow-up, guidelines recommend the implementation of methods aimed at improving adherence with such programs. The applicability to older pts of Home-Based exercise programs aimed at enhancing the adherence with prescriptions and maintaining the physiological benefits attained during the in-Hospital training period, is a further issue still to be clarified. The goal of this study is to determine in pts older than 75 years the medium- (6 months) and long-term (12 months) effects of a Home-Based exercise program after in-Hospital comprehensive CR, as compared with usual care, on exercise capacity, health-related quality of life and health care services utilization.
Pts older than 75 years who are candidate to an in-Hospital comprehensive CR program after acute coronary syndromes (ACS), percutaneous coronary intervention (PCI) or cardiac surgery (coronary artery by-pass graft and/or valvular surgery), will be screened for eligibility in the trial, and will be enrolled provided they do not meet any of the exclusion criteria. At baseline, at completion of CR program, and at 6- and 12-month follow-up, the following data will be assessed in all enrolled pts:
At discharge from in-Hospital CR program, pts will be randomly allocated to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | A:Home-Based exercise program,-at discharge from in-Hospital CR program-, with one reinforcement session each month for the first 6 months. |
|
| B | No Intervention | Usual care, after CR, consisting of recommendation on usefulness of physical exercise and standard follow-up visits and functional assessment at 6 and 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A: Home-Based exercise after Cardiac Rehabilitation | Other | Home-Based exercise program,after CR, with reinforcement sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| health-related quality of life and health care services utilization rates. | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Fattirolli, MD, PhD | Contact | +39 055 7949470 | francesco.fattirolli@unifi.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Fattirolli, MD, PhD | Azienda Ospedaliero-Universitaria Careggi - Florence, Italy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Careggi - Florence | Recruiting | Florence | 50141 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31180763 | Derived | Pratesi A, Baldasseroni S, Burgisser C, Orso F, Barucci R, Silverii MV, Venturini S, Ungar A, Marchionni N, Fattirolli F. Long-term functional outcomes after cardiac rehabilitation in older patients. Data from the Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active follow-up (CR-AGE EXTRA) randomised study. Eur J Prev Cardiol. 2019 Sep;26(14):1470-1478. doi: 10.1177/2047487319854141. Epub 2019 Jun 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 12, 2017 | |
| Reset | Jun 29, 2017 | |
| Release | Oct 2, 2017 | |
| Reset | Jul 13, 2018 | |
| Release | Feb 4, 2019 | |
| Reset | May 3, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 12, 2017 | Jun 29, 2017 | |||
| Oct 2, 2017 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Jul 13, 2018 |
| Feb 4, 2019 | May 3, 2019 |