An interventional study of T-REX Twente precautions and Usual (restrictive) sternal precautions in Sternotomy, Cardiovascular Diseases and Physical Inactivity, sponsored by Medisch Spectrum Twente. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Medisch Spectrum Twente · Not applicable, Interventional, and Treatment
The goal of this study is whether 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?
Participants will be 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.
Researchers will compare heart patients after a total median sternotomy with T-REX Twente precautions (intervention group) to the (current) standard precautions (control group).
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.
This is a prospective randomized double blind study, collecting data from patients undergoing a total median sternotomy from November 2023 to November 2025 at TCT and concurrently participating in outpatient cardiac rehabilitation under the guidance of TCT.
Previous research using the MacNew quality of life questionnaire among 677 cardiac rehabilitation patients indicated that the difference in response was normally distributed with a standard deviation of 0.25. The KvL-H is the Dutch (validated) translation of the MacNew QLMI. Assuming an effect size of 0.15 (small effect size) across the 4 measurement moments (T0, T2, T4) between the two groups (group*time interaction), a total of 154 patients were needed, i.e. 77 per group. This was based on a Repeated measures ANOVA with an alpha of 0.05, a power of 0.80 and a nonsphericity correction of 1, calculated with G*Power 3.1.9.7. To account for a 10% dropout, 77 patients per group will be included.
A previous study on intensified walking during cardiac rehabilitation after acute myocardial infarction showed a KvL-H increase of 0.9 at the time of discharge (our study: T3) to intake cardiac rehabilitation (our study: T4) from 5.2 to 6.1 at the time of T5. A KvL-H increase of at least 0.15 points is expected in our T-REX Twente sternal precautions group (intervention group); a minimal clinical difference corresponding to a standarized response mean of 0.2.
For the second primary endpoint, the relative percentage of daytime (between 6:00 and 23:00) non-bedtime up to and including 4 days postoperatively on the ICU and nursing ward is examined. From previous research in a similar population, it was observed that a relative rate of lying in bed of 60% is measured on day 1 after discharge from ICU, with a decrease of 6.5% per day (p \< 0.001). Assuming a reduction on day 1 to 50%, the medium f2 effect size of 0.5 with a linear mixed model, two-sided testing, alpha of 0.05, power of 0.80 and two predictors (time and group), results in 14 patients needed per group.
The highest number of patients will be retained, i.e. 77 patients per group.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 154 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Medisch Spectrum Twente is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
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The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: T-REX Twente precautions
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.
Behavioral: Usual (restrictive) sternal precautions
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).
Also known as: The T-REX Twente precautions are inspired on the Keep Your Move in the Tube (KYMITT) principle, and adjusted and improved to our local setting
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.
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
The first primary endpoint is the standardized response mean difference of Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI) pre-operative until the start of cardiac rehabilitation (4-6 weeks postoperatively). MacNew QLMI scores on a 7-pointscale (1-7), where 1 = always and 7 = never. MacNew QLMI is an ordinal scale, with a total sumscore of 189 points as the maximum quality of life.
Time frame: Preoperative to start of cardiac rehabilitation (4-6 weeks postoperatively)
Not lying in bed
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.
Time frame: Postoperative day 0 to postoperative day 4
Numeric (Pain) Rating Scale (NPRS)
Difference in experienced pain (self-reported) as measured with NPRS It is an 11-point ordinal scale (0-10) with 0 = no pain whatsoever, 10 = the worst pain most pain imaginable.
Time frame: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
Difference in QoL as measured with MacNew QLMI. MacNew QLMI scores on a 7-pointscale (1-7), where 1 = always and 7 = never. MacNew QLMI is an ordinal scale, with a total sumscore of 189 points as the maximum quality of life.
Time frame: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Tampa Scale for Kinesiophobia (TSK)
Difference in kinesiophobia as measured with TSK. The questionnaire consists of 17 items where a higher score represents a higher degree of fear of movement.
Time frame: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Individual mobilisation activities as measured with AX3 Accelerometer
During 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. Mobilisation activities include: lying in bed, sitting on a chair, standing, walking, cycling on a bike ergometer, walking the stairs.
Time frame: Postoperative (directly after surgery, day 0) until hospital discharge (expected to be around postoperative day 5 to a maximum of 7 days)
Composite endpoint of sternal refixation, superficial and deep sternal wounds for 30 days after surgery
Definitions according to Netherlands Heart Registration
Time frame: 30-days postoperative
Plan to share: Yes — It is not yet known if there will be a plan to make individual participant data (IPD) available. Study protocol and statistical analysis plan might be published.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Protocol is expected to be submitted for publication in 2024
Access criteria: Principal Investigator generally supports Open Access publishing and data sharing.
Started May 2024 (actual). Primary completion is estimated for Jan 2026, 20 months after the start.
Of 1,077 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 20 months is below that.
Counting every sponsor, half of 1,216 studies reached it within 26 months; a quarter within 12 and three quarters within 49.
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