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

NCT00641134 | Unknown

• 1 other identifier: 93/2007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Cardiac Rehabilitation; Old age; Home physical training

Outcome Measures

Primary Outcomes (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.

  6 and 12 months

Secondary Outcomes (1)

• health-related quality of life and health care services utilization rates.

  6 and 12 months

Study Arms (2)

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.

Other: A: Home-Based exercise after Cardiac Rehabilitation

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.

Interventions

A: Home-Based exercise after Cardiac Rehabilitation OTHER

Home-Based exercise program,after CR, with reinforcement sessions

Also known as: Home-based exercise after CR

A

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Women and men
• Aged \>75 years
• Candidates to a 4-week
• In-Hospital comprehensive CR after ACS
• PCI
• Cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Careggi - Florence

Florence, 50141, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 31180763 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Francesco Fattirolli, MD, PhD

  Azienda Ospedaliero-Universitaria Careggi - Florence, Italy

  STUDY DIRECTOR

Central Study Contacts

Francesco Fattirolli, MD, PhD

CONTACT

+39 055 7949470; francesco.fattirolli@unifi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 24, 2008
• Study Start: April 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2010
• Last Updated: February 6, 2009

Record last verified: 2009-02

Locations

IT (1)