Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06115759

RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy

Led by Medisch Spectrum Twente · Updated on 2025-02-07

154

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

Sponsors

M

Medisch Spectrum Twente

Lead Sponsor

F

Foothills Medical Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients undergoing a total median sternotomy at Thorax Centrum Twente
  • Patients whose treating cardiologist works at Thorax Centrum Twente
Not Eligible

You will not qualify if you...

  • Admission to Intensive Care Unit for more than 72 hours
  • Postoperative delirium diagnosed by DSM-V
  • Patients with dementia or other significant cognitive disorders
  • Patients with Dutch language barriers
  • Patients whose cardiologist is not affiliated with Thorax Centrum Twente

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Thoraxcentrum Twente

Enschede, Overijssel, Netherlands, 7500KA

Actively Recruiting

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Research Team

N

Nicole Wielens, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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