NCT06115759 RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy
| NCT ID | NCT06115759 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medisch Spectrum Twente |
| Condition | Sternotomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2024-05-21 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 154 participants in total. It began in 2024-05-21 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Adult patients who are preoperatively included if they are undergoing a total median sternotomy at Thorax Centrum Twente (TCT) * Patients with their treating cardiologist also working for TCT. Exclusion Criteria: * \>72 hours of admission to the Intensive Care Unit (ICU) * Postoperative delirium (diagnosed with Diagnostic and Statistical Manual of Mental Disorders (DSM) version V * Patients with dementia (or other significant cognitive disorders) * Dutch language barriers * Patients with a cardiologist from a location other than TCT
Contact & Investigator
Frank R. Halfwerk, MD, PhD
PRINCIPAL INVESTIGATOR
Medisch Spectrum Twente, Enschede, the Netherlands
Frequently Asked Questions
Who can join the NCT06115759 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sternotomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06115759 currently recruiting?
Yes, NCT06115759 is actively recruiting participants. Contact the research team at n.wielens@mst.nl for enrollment information.
Where is the NCT06115759 trial being conducted?
This trial is being conducted at Enschede, Netherlands.
Who is sponsoring the NCT06115759 clinical trial?
NCT06115759 is sponsored by Medisch Spectrum Twente. The principal investigator is Frank R. Halfwerk, MD, PhD at Medisch Spectrum Twente, Enschede, the Netherlands. The trial plans to enroll 154 participants.