Clinical trial NCT03223558: Early Initiation of Post Sternotomy CArdiac Rehabilitation
Official title: Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease
Keywords: cardiac rehabilitation
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: Coventry University
First posted: 2017-07-21
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Six Minute Walk Test Distance
timeFrame: 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:
measure: Five Times Sit to Stand (Timed)
timeFrame: 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.
measure: Handgrip Strength
timeFrame: 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.
measure: Leg Strength
timeFrame: 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.
measure: Euroqol 5 Dimensions Questionnaire
timeFrame: 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.
measure: Short Form (SF) -12 Questionnaire
timeFrame: 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.
measure: Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9
timeFrame: 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.
measure: Client Service Receipt Inventory (CSRI) Questionnaire
timeFrame: 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 outcomes:
measure: Adverse Events
timeFrame: 12 months from surgery.
Locations:
city: Coventry
country: United Kingdom
facility: UHCW NHS trust
state: West Midlands
Study officials:
affiliation: UHCW NHS trust
name: Stuart A Ennis
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.