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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Not lying in bed
研究概览
简要总结
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).
详细描述
Each year, more than 1000 open-heart surgeries (OHO) are performed at Thorax Centrum Twente (TCT), with 860 of them involving a total median sternotomy. Some patients present themselves at the cardiac care unit with unexplained complaints after discharge, possibly caused by anxiety and insecurity.
There is no consensus regarding postoperative sternal precautions following a total median sternotomy. Studies in the United States and Canada have indicated that these precautions might be too strict, and alternative, less restrictive precautions through the use of the "Keep your Move in the Tube" (KYMITT) approach have been shown safe and without adverse consequences.
Although no statistically significant differences were observed in all outcomes, patients following the new approach (KYMITT) reported fewer issues with functional mobility.
This is a prospective randomized double blind study, collecting data from patients undergoing a total median sternotomy from November 2023 to November 2025 at TCT and concurrently participating in outpatient cardiac rehabilitation under the guidance of TCT.
Previous research using the MacNew quality of life questionnaire among 677 cardiac rehabilitation patients indicated that the difference in response was normally distributed with a standard deviation of 0.25. The KvL-H is the Dutch (validated) translation of the MacNew QLMI. Assuming an effect size of 0.15 (small effect size) across the 4 measurement moments (T0, T2, T4) between the two groups (group*time interaction), a total of 154 patients were needed, i.e. 77 per group. This was based on a Repeated measures ANOVA with an alpha of 0.05, a power of 0.80 and a nonsphericity correction of 1, calculated with G*Power 3.1.9.7. To account for a 10% dropout, 77 patients per group will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will not be actively informed on their study arm, but will receive conventional or interventional rehabilitation instructions, and might be able to deduct their allocation arm.
The researcher will be blinded for intervention or control group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •>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
结局指标
主要结局
Not lying in bed
时间窗: 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.
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
时间窗: 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.
次要结局
- Numeric (Pain) Rating Scale (NPRS)(Preoperative to end of cardiac rehabilitation (12 weeks postoperatively))
- Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)(Preoperative to end of cardiac rehabilitation (12 weeks postoperatively))
- Individual mobilisation activities as measured with AX3 Accelerometer(Postoperative (directly after surgery, day 0) until hospital discharge (expected to be around postoperative day 5 to a maximum of 7 days))
- Tampa Scale for Kinesiophobia (TSK)(Preoperative to end of cardiac rehabilitation (12 weeks postoperatively))
- Composite endpoint of sternal refixation, superficial and deep sternal wounds for 30 days after surgery(30-days postoperative)
研究者
Frank Halfwerk
Assistant Professor and Technical Medical Doctor in Cardio-Thoracic Surgery
Medisch Spectrum Twente