Early Initiation of Post Sternotomy CArdiac Rehabilitation

NCT03223558 | Completed

• 1 other identifier: SE191516
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Keywords

cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Five Times Sit to Stand (Timed)

  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

  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

  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

  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

  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.

Other Outcomes (1)

• Adverse Events

  12 months from surgery.

Study Arms (2)

early rehab group

EXPERIMENTAL

start of 8 weeks cardiac rehabilitation 2 weeks following surgery

Behavioral: timing of initiation of cardiac rehabilitation

usual care group

ACTIVE COMPARATOR

start 8 weeks of cardiac rehabilitation 6 weeks post surgery

Behavioral: timing of initiation of cardiac rehabilitation

Interventions

timing of initiation of cardiac rehabilitation BEHAVIORAL

earlier timing of cardiac rehabilitation

early rehab group; usual care group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Coventry University: collaborator

Study Sites (1)

UHCW NHS trust

Coventry, West Midlands, Cv2 2DX, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35731506 DERIVED

• 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.

  PMID: 29574443 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases

Study Officials

• Stuart A Ennis

  UHCW NHS trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 21, 2017
• Study Start: July 10, 2017
• Primary Completion: August 5, 2020
• Study Completion: August 5, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)