Aortic Valve Disease, Coronary Artery Disease, Mitral Valve Disease
Conditions
Keywords
cardiac rehabilitation
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.
Interventions
BEHAVIORALtiming of initiation of cardiac rehabilitation
earlier timing of cardiac rehabilitation
Sponsors
Coventry University
University Hospitals Coventry and Warwickshire NHS Trust
Study design
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Six Minute Walk Test Distance | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Time taken to stand up and sit down five times |
| 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. | Participant squeezes dynamometer as forcefully as possible. 3 times in each hand. |
| 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. | Isometric quadriceps extension. Measured using a dynamometer. |
| 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. | 12 Question Quality of Life Questionnaire |
| 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. | General Anxiety and Depression Questionnaire |
| 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 | health service use questionnaire for economic analysis |
| 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. | Quality of life/cost benefit analysis questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 months from surgery. | Number, type and severity of adverse events during trial |
Countries
United Kingdom
Outcome results
None listed