To compare the effects of a preoperative PA program in addition to usual care versus usual care only on the change in SB from baseline (T0) to the end of the preoperative (intervention) period (T1) in patients with TAD.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the difference between the control group and
intervention group in the change in SB (h/day) from baseline (T0) to
preoperative follow-up (T1). SB will be assessed using the validated ActivPAL
micro (ActivPAL micro, PAL technologies, Glasgow, United Kingdom) activity
monitor.
Secondary outcome
The secondary study parameters are the differences between the control group
and intervention group in changes in:
* SB from baseline (T0) to postoperative follow-ups (T3 and T4);
* PA levels (h/day walking and stepping) from baseline (T0) to pre- and
postoperative follow-ups (T1, T3 and T4);
* BP levels from baseline (T0) to pre- (T1) and postoperative follow-up (T4);
* maximal handgrip strength from baseline (T0) to pre- and postoperative
follow-ups (T1, T3 and T4).
* cerebral perfusion levels from baseline (T0) to intra- and postoperative
follow-up (T2 and T4);
* cognitive function from baseline (T0) to postoperative follow-up (T4);
* functional exercise capacity from baseline (T0) to pre- and postoperative
follow-up (T1 and T4);
* anxiety for performing exercise and/or PA from baseline (T0) to pre- and
postoperative follow-up (T1 and T4).
Background summary
Most patients with thoracic aortic disease (TAD), mostly involving aneurysms or
dissections, ultimately undergo thoracic aortic surgery (TAS) to prevent fatal
rupture. TAS involves complex and intensive procedures, thus represents a
significant perturbation to the human body, in particular to the brain.
Although cerebral perfusion strategies can protect the brain during TAS,
perioperative cerebral (hypo-)perfusion may relate to high rates of
postoperative neurological deficits.
TAD patients are advised to modify their lifestyle, e.g. by quitting smoking
and controlling blood pressure. High intensity levels of physical activity (PA)
are discouraged, as sudden hemodynamic changes (e.g. increased blood pressure)
are unfavourable. However, low intensity levels of PA (e.g. walking or
standing) are considered to be safe, and, moreover, are known to have many
beneficial effects on cardiovascular and general, whereas sedentary behaviour
(SB, i.e. physical inactivity) is the most important modifiable risk factor for
cardiovascular disease. Moreover, reducing SB has been shown to enhance
cerebral perfusion. With regard to TAD, in mice with Marfan syndrome,
beneficial effects of low intensity PA were found on the thoracic aortic
diameter and aortic wall strength. Therefore, replacing SB by low intensity
levels of PA in patients with TAD is a promising strategy to improve
perioperative cardio- and cerebrovascular health, possibly improving
postoperative outcome. In addition, isometric handgrip (IHG) training is a
promising adjunct lifestyle intervention in order to reduce blood pressure
levels and cardiovascular risk. IHG may also be a preconditioning stimulus that
lowers tissue injury during surgery that is associated with tissue injury due
to periods of (local) ischaemia.
A preoperative physical activity program has been developed in order to promote
perioperative health in patients with TAD, involving an existing intervention
to promote physical activity levels, reduce SB, and perform IHG training.
Study objective
To compare the effects of a preoperative PA program in addition to usual care
versus usual care only on the change in SB from baseline (T0) to the end of the
preoperative (intervention) period (T1) in patients with TAD.
Study design
A randomized controlled trial comparing the preoperative PA program in addition
to usual care versus usual care only.
Intervention
In addition to usual care, the intervention group will follow the preoperative
PA program, whereas the control group will receive usual care only. The PA
intervention involves an existing intervention to reduce SB by wearing a
physical activity monitor (Activ8) that provides vibrotactile and web-based
feedback, together with additional IHG training (30% MVC, 3x/week).
Additionally, patients are weekly coached and supported online or by phone.
Study burden and risks
Since all study procedures and used measurement techniques are non-invasive,
the nature and extent of burden and risks associated with the intervention and
measurements are negligible.
Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Philips van Leydenlaan 15
Nijmegen 6525 EX
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL75371.091.20 |
| Other | NTR: NL8975 |
| OMON | NL-OMON22457 |