Aortic Valve Stenosis Clinical Trial
Official title:
Preventive Heart Rehabilitation in Patients Undergoing Elective Open Heart Surgery to Prevent Complications and to Improve Quality of Life (Heart-ROCQ) - A Prospective Randomized Open Controlled Trial, Blinded End-point (PROBE)
Rationale:
Patients undergoing cardiac surgery are at risk of developing perioperative complications and
major adverse cardiac events, mainly related to both their preoperative status and type of
surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective
therapy to prolong survival and improve quality of life. However, little is known about the
effect on post-operative complications, quality of life and return to work of a combined pre-
and post-operative CR program encompassing physical therapy, dietary counseling,
psychological support and life style management compared to a CR program, which is provided
only after cardiac surgery.
Objective:
to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to
three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction
in postoperative surgical complications, readmissions to hospital and major adverse cardiac
events in conjunction with improvements in the physical component of health related quality
of life), when compared to postoperative CR only (POST).
Study design:
A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized
between two standard care CR programs. One group will start a the POST CR program after
surgery. The other group will be randomized to a combined PRE+POST CR program.
Study population:
Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery and/or
aortic surgery
Main study parameters/endpoints:
The primary outcome is a composite weighted endpoint of postoperative surgical complications,
re-admissions to hospital, major adverse cardiac events and health related quality of life
(two domains: physical functioning and physical problem), at three months and one year after
surgery. Endpoints are determined by an independent endpoint committee, blinded to the group
allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness,
muscle strength and functional status), psychological health (feelings of anxiety and
depression), work participation, economics, lifestyle risk factors (physical activity and
smoking behavior), self-efficacy and illness representations.
n/a
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