A randomized clinical trial to study positive effects of T-REX Twente regimen (Thoracic surgery Rehabilitation Experts Twente) on quality of life and mobilisation activities for cardiac surgery patients after full median sternotomy, compared to usual care
Recruiting
- Conditions
- cardio-thoracic surgery with median sternotomyheart surgery1008220610007593
- Registration Number
- NL-OMON56700
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 154
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The first primary endpoint is the standardized response mean difference of<br /><br>Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)<br /><br>clinically postoperative (4th day postoperatively) until the start of cardiac<br /><br>rehabilitation (4-6 weeks postoperatively).<br /><br>The second primary endpoint is the duration of not being in bed for up to 4<br /><br>days in the ICU and the general ward, measured using two AX3 accelerometers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secundary endpoints include a difference in experienced pain as measured with<br /><br>NPRS, quality of life (MacNew QLMI) and kinesiophobia as measured with TSK<br /><br>preoperatively to end of cardiac rehabiliation.<br /><br>Other endpoints include the actual activities per day (actual in minutes and<br /><br>relative to all mobilisation activities) for lying in bed, sitting, standing,<br /><br>walking, biking on ergometer, and walking the stairs until hospital discharge.<br /><br>Last, a combined endpont of sternal refixation, superficial and deep sternal<br /><br>wounds for 30 days after surgery. </p><br>