A preoperative program to promote peri- and postoperative health in patients undergoing thoracic aortic surgery: a randomized controlled trial.
Completed
- Conditions
- thoracic aortic diseasethoracic aortic aneurysm100122211000318410002363
- Registration Number
- NL-OMON50977
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
Patients that are:
- visiting the cardiothoracic surgery outpatient clinic prior to probable
thoracic aortic surgery;
- aged 18 years or older;
- able to understand and perform study related procedures.
Exclusion Criteria
Patients that are:
- unable to provide signed and dated informed consent form;
- wheelchair-bounded or physically unable to stand or walk;
- currently enrolled in another interventional study targeting either sedentary
behaviour and/or physical activity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is the difference between the control group and<br /><br>intervention group in the change in SB (h/day) from baseline (T0) to<br /><br>preoperative follow-up (T1). SB will be assessed using the validated ActivPAL<br /><br>micro (ActivPAL micro, PAL technologies, Glasgow, United Kingdom) activity<br /><br>monitor.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study parameters are the differences between the control group<br /><br>and intervention group in changes in:<br /><br>* SB from baseline (T0) to postoperative follow-ups (T3 and T4);<br /><br>* PA levels (h/day walking and stepping) from baseline (T0) to pre- and<br /><br>postoperative follow-ups (T1, T3 and T4);<br /><br>* BP levels from baseline (T0) to pre- (T1) and postoperative follow-up (T4);<br /><br>* maximal handgrip strength from baseline (T0) to pre- and postoperative<br /><br>follow-ups (T1, T3 and T4).<br /><br>* cerebral perfusion levels from baseline (T0) to intra- and postoperative<br /><br>follow-up (T2 and T4);<br /><br>* cognitive function from baseline (T0) to postoperative follow-up (T4);<br /><br>* functional exercise capacity from baseline (T0) to pre- and postoperative<br /><br>follow-up (T1 and T4);<br /><br>* anxiety for performing exercise and/or PA from baseline (T0) to pre- and<br /><br>postoperative follow-up (T1 and T4).</p><br>