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

Condition(s) studied

Investigational drug(s) / intervention(s)

T-REX Twente 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).

Usual (restrictive) sternal 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.

Study 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

Primary outcome measure(s)

• Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI) — Preoperative to start of cardiac rehabilitation (4-6 weeks postoperatively)
  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.
• Not lying in bed — Postoperative day 0 to postoperative day 4
  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.

Trial sites (1)

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