RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedisch Spectrum Twente
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
>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
Trial design
Design model
Parallel
Treatments tested in this trial
T-REX Twente precautions
BehavioralThe 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
BehavioralThe 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.
Treatment groups
154 Participants
are divided into 2 treatment groupsGroup A: T-REX TwenteExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
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.
Time frame
Preoperative to start of cardiac rehabilitation (4-6 weeks postoperatively)2
Not lying in bed
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.
Time frame
Postoperative day 0 to postoperative day 4Secondary outcomes
1
Numeric (Pain) Rating Scale (NPRS)
Difference in experienced pain (self-reported) as measured with NPRS It is an 11-point ordinal scale (0-10) with 0 = no pain whatsoever, 10 = the worst pain most pain imaginable.
Time frame
Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)2
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
Difference in QoL as measured with MacNew QLMI. 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.
Time frame
Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)3
Tampa Scale for Kinesiophobia (TSK)
Difference in kinesiophobia as measured with TSK. The questionnaire consists of 17 items where a higher score represents a higher degree of fear of movement.
Time frame
Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)4
Individual mobilisation activities as measured with AX3 Accelerometer
During 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. Mobilisation activities include: lying in bed, sitting on a chair, standing, walking, cycling on a bike ergometer, walking the stairs.
Time frame
Postoperative (directly after surgery, day 0) until hospital discharge (expected to be around postoperative day 5 to a maximum of 7 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medisch Spectrum Twente
Lead sponsor
Foothills Medical Centre
Collaborator
Source ClinicalTrials.gov