Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up CR-AGE-EXTRA Trial

Cardiovascular Disease Clinical Trial

— CR-AGE-EXTRA  

Official title:

Cardiac Rehabilitation in Advanced aGE: EXercise TRaining and Active Follow-up, a Randomised Controlled Trial. CR-AGE EXTRA Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00641134
• Other study ID #: 93/2007
• Status: Unknown status
• Phase: N/A
• First received: March 18, 2008
• Last updated: February 5, 2009
• Start date: April 2008
• Est. completion date: November 2010

Study information

• Verified date: February 2009
• Source: University of Florence
• Contact: Francesco Fattirolli, MD, PhD
• Phone: +39 055 7949470
• Email: francesco.fattirolli[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 80
• Est. completion date: November 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Women and men

• Aged >75 years

• Candidates to a 4-week

• In-Hospital comprehensive CR after ACS

• PCI

• Cardiac surgery

Exclusion Criteria:

• Any medical condition that would make physical exercise unsafe (unstable angina, sustained ventricular arrhythmias, AF with elevated ventricular response, symptomatic COPD, uncontrolled arterial hypertension, uncontrolled diabetes, hyperthyroidism) or that would limit physical capacity (severe anemia (Hb<10 gr/dl), moderate-to-severe chronic renal failure (creatinine >2.5 mg/dl), severe arthritis, peripheral artery disease (Fontaine >IIb), metastatic cancer)

• Symptomatic (NYHA II-IV) chronic heart failure

• Moderate-to-severe left ventricular systolic dysfunction (left ventricular ejection fraction <35%)

• BADL disability

• Denied informed consent

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• A: Home-Based exercise after Cardiac Rehabilitation
Home-Based exercise program,after CR, with reinforcement sessions

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Careggi - Florence	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	health-related quality of life and health care services utilization rates.		6 and 12 months