Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Change in Six Minute Walk Test Distance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
early rehab group
start of 8 weeks cardiac rehabilitation 2 weeks following surgery
Intervention: timing of initiation of cardiac rehabilitation (Behavioral)
usual care group
start 8 weeks of cardiac rehabilitation 6 weeks post surgery
Intervention: timing of initiation of cardiac rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Change in Six Minute Walk Test Distance
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.
Distance walked unassisted in 6 minutes
Secondary Outcomes
- 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.)
- Client Service Receipt Inventory (CSRI) Questionnaire(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)
- Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9(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.)
- 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.)
- 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.)