Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up CR-AGE-EXTRA Trial (CR-AGE-EXTRA)
Recruitment status was: Recruiting
|Cardiovascular Disease||Other: A: Home-Based exercise after Cardiac Rehabilitation|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up, a Randomised Controlled Trial. CR-AGE EXTRA Trial|
- 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. [ Time Frame: 6 and 12 months ]
- health-related quality of life and health care services utilization rates. [ Time Frame: 6 and 12 months ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
A:Home-Based exercise program,-at discharge from in-Hospital CR program-, with one reinforcement session each month for the first 6 months.
Other: A: Home-Based exercise after Cardiac Rehabilitation
Home-Based exercise program,after CR, with reinforcement sessions
Other Name: Home-based exercise after CR
No Intervention: B
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.
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:
- functional capacity, expressed as total work capacity (TWC, watt) and maximal aerobic capacity (peak VO2, ml/kg/min) during a symptom-limited cardiopulmonary exercise test
- endurance, expressed by the distance covered during a 6-minute walk test (6MWT)
- lower limb muscular strength, measured with an isokinetic dynamometer
- health-related quality of life (SF 36 questionnaire)
- utilization rates of health care services
At discharge from in-Hospital CR program, pts will be randomly allocated to:
- Home-Based exercise program, consisting of a prescription of a specific set of exercises detailed and actively recorded in a log book, with one reinforcement session at the Rehabilitation Centre each month for the first 6 months.
- Usual care, consisting of recommendation on usefulness of physical exercise and standard follow-up visits and functional assessment at 6 and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641134
|Contact: Francesco Fattirolli, MD, PhD||+39 055 firstname.lastname@example.org|
|Azienda Ospedaliero-Universitaria Careggi - Florence||Recruiting|
|Florence, Italy, 50141|
|Contact: Francesco Fattirolli, MD, PhD +39 055 7949470 email@example.com|
|Sub-Investigator: Costanza Burgisser, MD|
|Study Director:||Francesco Fattirolli, MD, PhD||Azienda Ospedaliero-Universitaria Careggi - Florence, Italy|