Effects of T-REX Twente precautions on recovery after heart surgery
A Randomized Clinical Trial to Study the "T-REX Twente Regimen" (Thoracic Surgery Rehabilitation Experts Twente) on Quality of Life and Mobilisation Activities for Cardiac Surgery Patients After Median Sternotomy, Compared to Usual Care
This study is testing if following new T-REX Twente precautions helps people recover better and feel less afraid of moving after heart surgery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medisch Spectrum Twente Academic / other |
| Locations | 1 site (Enschede, Overijssel) |
| Trial ID | NCT06115759 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the T-REX Twente precautions improve quality of life, physical activity, and reduce fear of movement in patients recovering from total median sternotomy compared to standard precautions. Participants will be randomly assigned to either the intervention group, which follows the new T-REX precautions, or the control group, which adheres to traditional restrictive precautions. Data will be collected through questionnaires assessing quality of life and mobility during the hospital stay and outpatient rehabilitation. The study aims to determine if the new approach leads to better recovery outcomes without increasing pain or complications.
Who should consider this trial
Good fit: Ideal candidates are adult patients undergoing total median sternotomy at Thorax Centrum Twente.
Not a fit: Patients with significant cognitive disorders, language barriers, or those admitted to the ICU for more than 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery and quality of life for cardiac surgery patients by allowing more independence during rehabilitation.
How similar studies have performed: Previous studies have suggested that less restrictive precautions may be safe and beneficial, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Enschede, Overijssel
- Thoraxcentrum Twente — Enschede, Overijssel, Netherlands (Recruiting)
Study contacts
- Principal investigator: Frank R. Halfwerk, MD, PhD — Medisch Spectrum Twente, Enschede, the Netherlands
- Study coordinator: Nicole Wielens, BSc
- Email: n.wielens@mst.nl
- Phone: 0031615060570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.