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Early Initiation of Post Sternotomy CArdiac Rehabilitation (SCAR)

Primary Purpose

Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
timing of initiation of cardiac rehabilitation
Sponsored by
University Hospitals Coventry and Warwickshire NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring cardiac rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UHCW NHS trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

early rehab group

usual care group

Arm Description

start of 8 weeks cardiac rehabilitation 2 weeks following surgery

start 8 weeks of cardiac rehabilitation 6 weeks post surgery

Outcomes

Primary Outcome Measures

Change in Six Minute Walk Test Distance
Distance walked unassisted in 6 minutes

Secondary Outcome Measures

Five Times Sit to Stand (Timed)
Time taken to stand up and sit down five times
Handgrip Strength
Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.
Leg Strength
Isometric quadriceps extension. Measured using a dynamometer.
Euroqol 5 Dimensions Questionnaire
Quality of life/cost benefit analysis questionnaire
Short Form (SF) -12 Questionnaire
12 Question Quality of Life Questionnaire
Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9
General Anxiety and Depression Questionnaire
Client Service Receipt Inventory (CSRI) Questionnaire
health service use questionnaire for economic analysis

Full Information

First Posted
July 5, 2017
Last Updated
May 4, 2021
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
Coventry University
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1. Study Identification

Unique Protocol Identification Number
NCT03223558
Brief Title
Early Initiation of Post Sternotomy CArdiac Rehabilitation
Acronym
SCAR
Official Title
Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
August 5, 2020 (Actual)
Study Completion Date
August 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Collaborators
Coventry University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease
Keywords
cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A single blinded parallel group randomised controlled trial will be used to determine non-inferiority of early (2 weeks post operation) vs usual care (6 weeks post operation ) CR for a period of 8 weeks.
Masking
Outcomes Assessor
Masking Description
researchers will be blinded during baseline assessment prior to group allocation. Participants and the clinical CR team will know the group allocation and therefore cannot be blinded. University hospitals for Coventry and Warwickshire NHS trust research and design department will generate the randomisation sequence remotely using permuted block randomisation.
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
early rehab group
Arm Type
Experimental
Arm Description
start of 8 weeks cardiac rehabilitation 2 weeks following surgery
Arm Title
usual care group
Arm Type
Active Comparator
Arm Description
start 8 weeks of cardiac rehabilitation 6 weeks post surgery
Intervention Type
Behavioral
Intervention Name(s)
timing of initiation of cardiac rehabilitation
Intervention Description
earlier timing of cardiac rehabilitation
Primary Outcome Measure Information:
Title
Change in Six Minute Walk Test Distance
Description
Distance walked unassisted in 6 minutes
Time Frame
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 Measure Information:
Title
Five Times Sit to Stand (Timed)
Description
Time taken to stand up and sit down five times
Time Frame
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.
Title
Handgrip Strength
Description
Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.
Time Frame
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.
Title
Leg Strength
Description
Isometric quadriceps extension. Measured using a dynamometer.
Time Frame
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.
Title
Euroqol 5 Dimensions Questionnaire
Description
Quality of life/cost benefit analysis questionnaire
Time Frame
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.
Title
Short Form (SF) -12 Questionnaire
Description
12 Question Quality of Life Questionnaire
Time Frame
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.
Title
Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9
Description
General Anxiety and Depression Questionnaire
Time Frame
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.
Title
Client Service Receipt Inventory (CSRI) Questionnaire
Description
health service use questionnaire for economic analysis
Time Frame
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 Pre-specified Outcome Measures:
Title
Adverse Events
Description
Number, type and severity of adverse events during trial
Time Frame
12 months from surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A Ennis
Organizational Affiliation
UHCW NHS trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHCW NHS trust
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
Cv2 2DX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35731506
Citation
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.
Results Reference
derived
PubMed Identifier
29574443
Citation
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.
Results Reference
derived

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Early Initiation of Post Sternotomy CArdiac Rehabilitation

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