Do the T-REX Twente precautions have a positive impact on the quality of life (MAcNew QLMI), level of physical activity, and reduction of fear of movement in heart patients after a total median sternotomy compared to the (current) standard…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The first primary endpoint is the standardized response mean difference of
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
clinically postoperative (4th day postoperatively) until the start of cardiac
rehabilitation (4-6 weeks postoperatively).
The second primary endpoint is the duration of not being in bed for up to 4
days in the ICU and the general ward, measured using two AX3 accelerometers.
Secondary outcome
Secundary endpoints include a difference in experienced pain as measured with
NPRS, quality of life (MacNew QLMI) and kinesiophobia as measured with TSK
preoperatively to end of cardiac rehabiliation.
Other endpoints include the actual activities per day (actual in minutes and
relative to all mobilisation activities) for lying in bed, sitting, standing,
walking, biking on ergometer, and walking the stairs until hospital discharge.
Last, a combined endpont of sternal refixation, superficial and deep sternal
wounds for 30 days after surgery.
Background summary
Each year, more than 1000 open-heart surgeries (OHO) are performed at Thorax
Centrum Twente (TCT), with 860 of them involving a total median sternotomy.
Some patients present themselves at the cardiac care unit with unexplained
complaints after discharge, possibly caused by anxiety and insecurity.
There is no consensus regarding postoperative sternal precautions following a
total median sternotomy. Studies in the United States and Canada have indicated
that these precautions might be too strict, and alternative, less restrictive
precautions through the use of the "Keep your Move in the Tube" (KYMITT)
approach have been shown safe and without adverse consequences.
Although no statistically significant differences were observed in all
outcomes, patients following the new approach (KYMITT) reported fewer issues
with functional mobility.
Study objective
Do the T-REX Twente precautions have a positive impact on the quality of life
(MAcNew QLMI), level of physical activity, and reduction of fear of movement in
heart patients after a total median sternotomy compared to the (current)
standard precautions?
Do these precautions also have no adverse effects on pain, wound healing,
and/or postoperative complications?
Study design
This is a prospective randomized double blind study, collecting data from
patients undergoing a total median sternotomy from February 2024 to April 2026
at TCT and concurrently participating in outpatient cardiac rehabilitation
under the guidance of TCT.
Intervention
The precautions are instructed by the physiotherapist to both groups
immediately postoperatively and are constantly repeated by the involved
disciplines during the hospital stay.
The control group is not allowed to lift, push, or pull for the first 6 weeks.
There is little to no evidence for the current strict precautions currently
implemented in the department.
The intervention group receives the new T-REX Twente precautions, allowing for
more independent activities through the use of the tube model (keeping elbows
close to the sides).
All patients receive three questionnaires (MacNew QLMI, Numeric Pain Rating
Scale, and Tampa Scale for Kinesiophobia) preoperatively, on the 4th day
postoperatively, on the first day of cardiac rehabilitation, and at the end of
cardiac rehabilitation, taking approximately 10 minutes each time.
Additionally, during the clinical admission immediately postoperatively, two
AX3 accelerometers are placed on the patient, one lateroproximal on the right
upper arm and one anterodistal on the right upper leg.
Study burden and risks
There is little to no evidence for the current strict precautions currently
implemented in the department.
Previous research in the United States and Canada has shown no additional
complications using the KYMITT approach.
During the study, we do not expect an increase in complications in either
group.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
Patients aged >= 18 years
Patients who receive cardiac surgery in Medisch Spectrum Twente with complete
median sternotomy access
Patients with their cardiologist working at Medisch Spectrum Twente
Exclusion criteria
• Postoperative ICU stay > 72 hours
• Delirium (DSM V) or dementia (or other major cognitive disorders)
• Dutch language barrier
• Cardiologist outside Medisch Spectrum Twente
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 | NCT06115759 |
| CCMO | NL78107.100.23 |