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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
158
earlier timing of cardiac rehabilitation
UHCW NHS trust
Coventry, West Midlands, United Kingdom
Change in Six Minute Walk Test Distance
Distance walked unassisted in 6 minutes
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.
Five Times Sit to Stand (Timed)
Time taken to stand up and sit down five times
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.
Handgrip Strength
Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.
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.
Leg Strength
Isometric quadriceps extension. Measured using a dynamometer.
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.
Euroqol 5 Dimensions Questionnaire
Quality of life/cost benefit analysis questionnaire
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.
Short Form (SF) -12 Questionnaire
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12 Question Quality of Life Questionnaire
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.
Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9
General Anxiety and Depression Questionnaire
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.
Client Service Receipt Inventory (CSRI) Questionnaire
health service use questionnaire for economic analysis
Time frame: 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