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

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ClinicalTrials.gov Identifier: NCT00641134
Recruitment Status : Unknown
Verified February 2009 by University of Florence.
Recruitment status was:  Recruiting
First Posted : March 24, 2008
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
University of Florence

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Other: A: Home-Based exercise after Cardiac Rehabilitation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
A
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. health-related quality of life and health care services utilization rates. [ Time Frame: 6 and 12 months ]


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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641134


Contacts
Contact: Francesco Fattirolli, MD, PhD +39 055 7949470 francesco.fattirolli@unifi.it

Locations
Italy
Azienda Ospedaliero-Universitaria Careggi - Florence Recruiting
Florence, Italy, 50141
Contact: Francesco Fattirolli, MD, PhD    +39 055 7949470    francesco.fattirolli@unifi.it   
Sub-Investigator: Costanza Burgisser, MD         
Sponsors and Collaborators
University of Florence
Investigators
Study Director: Francesco Fattirolli, MD, PhD Azienda Ospedaliero-Universitaria Careggi - Florence, Italy

Responsible Party: Francesco Fattirolli, MD, PhD, Azienda Ospedaliero-Universitaria Careggi - Florence, Italy
ClinicalTrials.gov Identifier: NCT00641134     History of Changes
Other Study ID Numbers: 93/2007
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by University of Florence:
Cardiac Rehabilitation
Old age
Home physical training

Additional relevant MeSH terms:
Cardiovascular Diseases