Early Initiation of Post Sternotomy CArdiac Rehabilitation (SCAR)

University Hospitals Coventry and Warwickshire NHS Trust

Status: Completed

Conditions: Mitral Valve Disease; Coronary Artery Disease; Aortic Valve Disease

Treatments: Behavioral: timing of initiation of cardiac rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03223558

SE191516

Details and patient eligibility

About

The main objective of this trial is to investigate the effects of starting exercise rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or Aortic/Mitral valve replacement (VR) surgery.

Full description

The trial will compare health improvements after cardiac rehabilitation, (CR) between participants randomly allocated to one of two groups: an early CR group starting exercise after 2 weeks, and a usual care group starting at 6 weeks. It will also collect information on the financial cost of earlier CR to both the health service and the patients.

All primary and secondary outcome measures will be taken at baseline (1 week) and repeated at the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months follow-up.

Enrollment: 158 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation
• Able to provide written informed consent
• Male or female 18 years of age or greater

Exclusion criteria

• Patients with any of the following:

  • Serious cardiac arrhythmias
  • Current neurological disorders or previous Cerebral Vascular Accident with residual neurological deficit significant enough to limit exercise
  • Enrolled on another clinical trial that involved exercise
  • Unable to enroll for duration of study

• Patients who are unable to provide written consent.

• Patients under the age of 18 or over the age of 90.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

early rehab group

Experimental group

Description:

start of 8 weeks cardiac rehabilitation 2 weeks following surgery

Treatment:

Behavioral: timing of initiation of cardiac rehabilitation

usual care group

Active Comparator group

Description:

start 8 weeks of cardiac rehabilitation 6 weeks post surgery

Treatment:

Behavioral: timing of initiation of cardiac rehabilitation