to determine whether a pre- and postoperative CR (PRE+POST) program improves the short (up to three months) and long term outcomes (up to one year) after cardiac surgery (i.e. reduction in postoperative surgical complications, readmissions to…
ID
Source
Brief title
Condition
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary, this study is designed to evaluate the effect of the cardiac
rehabilitation programs on:
- Prolonged stay at the intensive care, the occurrence arrhythmias and
rethoracotomies (Complications and events)
- Cardiorespiratory fitness, muscle strength and functional status (Physical
health)
- Feelings of anxiety, depression and quality of life (Psychological health)
- Work participation
- Economic evaluation: health care costs, work-related costs and quality
adjusted life years (QALYs)
- Physical activity and smoking consumption (Lifestyle risk factors)
- self-efficacy, illness representations (Potential mediators)
Background summary
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.
Study objective
to determine whether a pre- and postoperative CR (PRE+POST) program improves
the short (up to three months) and long term outcomes (up to one year) after
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 randomized controlled trial. Patients are randomized between two standard
care CR programs. One group will start the regular CR program after surgery.
The other group will be randomized to a combined pre- and postoperative CR
program.
Intervention
NA
Study burden and risks
The risks of the study measurements are minimal, because all studied parameters
are observational and non-invasive. Questionnaires and physical tests are
conducted. Eligible patients are asked to fill in six validated questionnaires
additional to standard care for three to four times (baseline, one day before
surgery, 3-4 months and one year after surgery). In addition, four
questionnaires (KATZ, PHQ-9, GAD and Rand-36_v2) are collected in standard care
as standard care procedure (*Meetbaar Beter*) and are repeated for one to two
times. Furthermore, patients are asked to perform four physical tests (6
minutes walking test, grip and leg strength and sit to stand test), which can
be conducted in 45 minutes. These tests are performed throughout the
rehabilitation program and after surgery at 3-4 months and after one year. Part
of these tests are conducted in the context of the CR program.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Accepted for elective coronary bypass surgery, degenerative valve disease or aortic surgery (or combined) under general anesthesia
Exclusion criteria
• Patients accepted for transcatheter aortic valve implantation (TAVI)
• Admitted to the department of congenital heart surgery
• Aortic descendens or dissections
• Elite athletes
• Co-morbidities that prevent participation in one or more program elements (e.g. disorders to the nervous or musculoskeletal system that limits exercise capacity, severe COPD (GOLD class 3-4), addiction to alcohol or drugs/ serious psychiatric illness) or when it is undesirable to exercise (e.g. cardiomyopathie/morrow).
• Other treatment planned that possibly will interrupt the cardiac rehabilitation program (for example on a waiting list for a organ transplantation, preoperative endocarditis or planned chemotherapy for cancer etc.)
• Unable to read and write Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02984449 |
| CCMO | NL58542.042.16 |