Cardiac rehabilitation versus standard care after aortic aneurysm repair (Aneurysm CaRe): study protocol for a randomised controlled trial

Trials. 2015 Apr 15:16:162. doi: 10.1186/s13063-015-0669-2.

Abstract

Background: Abdominal and thoracic aortic aneurysms (A/TAA) are an important cause of mortality amongst the older population. Although A/TAA repair can be performed with low peri-operative risk, overall life expectancy remains poor in the years that follow surgery. The majority of deaths are caused by heart attack or stroke, which can both be prevented by cardiac rehabilitation (CR) in patients with clinically-manifest coronary artery disease. A Cochrane review has urged researchers to widen the use of CR to other populations with severe cardiovascular risk, and patients surviving A/TAA repair appear ideal candidates. However, it is unknown whether CR is feasible or acceptable to A/TAA patients, who are a decade older than those currently enrolling in CR. Aneurysm-CaRe is a feasibility randomised controlled trial (RCT) that will address these issues.

Methods and design: Aneurysm-CaRe is a pilot RCT of CR versus standard care after A/TAA repair, with the primary objectives of estimating enrolment to a trial of CR after A/TAA repair and estimating compliance with CR amongst patients with A/TAA. Aneurysm-CaRe will randomise 84 patients at two sites. Patients discharged from hospital after elective A/TAA repair will be randomised to standard care or enrolment in their local CR programme with a protocolised approach to medical cardiovascular risk reduction. The primary outcome measures are enrolment in the RCT and compliance with CR. Secondary outcomes will include phenotypic markers of cardiovascular risk and smoking cessation, alongside disease-specific and generic quality-of-life measures.

Trial registration: ISRCTN 65746249 5 June 2014.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aortic Aneurysm, Abdominal / diagnosis
  • Aortic Aneurysm, Abdominal / mortality
  • Aortic Aneurysm, Abdominal / surgery*
  • Aortic Aneurysm, Thoracic / diagnosis
  • Aortic Aneurysm, Thoracic / mortality
  • Aortic Aneurysm, Thoracic / surgery*
  • Clinical Protocols
  • Community Health Services*
  • Feasibility Studies
  • Female
  • Humans
  • London
  • Male
  • Middle Aged
  • Myocardial Infarction / diagnosis
  • Myocardial Infarction / mortality
  • Myocardial Infarction / rehabilitation*
  • Patient Compliance
  • Patient Discharge
  • Pilot Projects
  • Quality of Life
  • Research Design
  • Risk Assessment
  • Risk Factors
  • Risk Reduction Behavior*
  • Smoking Cessation
  • Stroke / diagnosis
  • Stroke / mortality
  • Stroke Rehabilitation*
  • Time Factors
  • Treatment Outcome

Associated data

  • ISRCTN/ISRCTN65746249