Early Initiation of Post Sternotomy CArdiac Rehabilitation (SCAR)

Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease
• Intervention / Treatment: Behavioral: timing of initiation of cardiac rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV2 2DX
      • UHCW NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: early rehab group; start of 8 weeks cardiac rehabilitation 2 weeks following surgery	Behavioral: timing of initiation of cardiac rehabilitation; earlier timing of cardiac rehabilitation
ACTIVE_COMPARATOR: usual care group; start 8 weeks of cardiac rehabilitation 6 weeks post surgery	Behavioral: timing of initiation of cardiac rehabilitation; earlier timing of cardiac rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Six Minute Walk Test Distance	Distance walked unassisted in 6 minutes	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Times Sit to Stand (Timed)	Time taken to stand up and sit down five times	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Handgrip Strength	Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Leg Strength	Isometric quadriceps extension. Measured using a dynamometer.	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Euroqol 5 Dimensions Questionnaire	Quality of life/cost benefit analysis questionnaire	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Short Form (SF) -12 Questionnaire	12 Question Quality of Life Questionnaire	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9	General Anxiety and Depression Questionnaire	Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.
Client Service Receipt Inventory (CSRI) Questionnaire	health service use questionnaire for economic analysis	Early Group- Change between baseline, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 14 weeks post-surgery and 12 months follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number, type and severity of adverse events during trial	12 months from surgery.

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust
• Collaborators: Coventry University
• Investigators: Principal Investigator: Stuart A Ennis, UHCW NHS Trust

Publications and helpful links

General Publications

• Ennis S, Lobley G, Worrall S, Evans B, Kimani PK, Khan A, Powell R, Banerjee P, Barker T, McGregor G. Effectiveness and Safety of Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training: The SCAR Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):817-824. doi: 10.1001/jamacardio.2022.1651.
• Ennis S, Lobley G, Worrall S, Powell R, Kimani PK, Khan AJ, Banerjee P, Barker T, McGregor G. Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation. BMJ Open. 2018 Mar 23;8(3):e019748. doi: 10.1136/bmjopen-2017-019748.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2017
• Primary Completion (ACTUAL): August 5, 2020
• Study Completion (ACTUAL): August 5, 2020

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: cardiac rehabilitation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Valve Diseases; Coronary Disease; Coronary Artery Disease; Aortic Valve Disease
• Other Study ID Numbers: SE191516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No