Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-06 @ 2:21 AM
Study NCT ID:
NCT00641134
Status:
UNKNOWN
Last Update Posted:
2009-02-06
First Post:
2008-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up CR-AGE-EXTRA Trial
Sponsor:
University of Florence
Organization:
Study Overview
Official Title:
Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up, a Randomised Controlled Trial. CR-AGE EXTRA Trial
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CR-AGE-EXTRA
Brief Summary:
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.
Detailed Description:
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:
1. 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.
2. Usual care, consisting of recommendation on usefulness of physical exercise and standard follow-up visits and functional assessment at 6 and 12 months.
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:
1. 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.
2. Usual care, consisting of recommendation on usefulness of physical exercise and standard follow-up visits and functional assessment at 6 and 12 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: