Early Initiation of Post Sternotomy CArdiac Rehabilitation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease

Intervention / Treatment
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* Behavioral: timing of initiation of cardiac rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early rehab group<br>start of 8 weeks cardiac rehabilitation 2 weeks following surgery | Behavioral: timing of initiation of cardiac rehabilitation<br>* earlier timing of cardiac rehabilitation<br>|
| Active Comparator: usual care group<br>start 8 weeks of cardiac rehabilitation 6 weeks post surgery | Behavioral: timing of initiation of cardiac rehabilitation<br>* earlier timing of cardiac rehabilitation<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation