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

Cardiovascular Diseases Clinical Trial

— T-REX Twente  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115759
• Other study ID #: T-REX Twente
• Secondary ID: CCMO-ABR 78107
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Medisch Spectrum Twente
• Contact: Nicole Wielens, BSc
• Phone: 0031615060570
• Email: n.wielens[@]mst.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

A previous study on intensified walking during cardiac rehabilitation after acute myocardial infarction showed a KvL-H increase of 0.9 at the time of discharge (our study: T3) to intake cardiac rehabilitation (our study: T4) from 5.2 to 6.1 at the time of T5. A KvL-H increase of at least 0.15 points is expected in our T-REX Twente sternal precautions group (intervention group); a minimal clinical difference corresponding to a standarized response mean of 0.2.

For the second primary endpoint, the relative percentage of daytime (between 6:00 and 23:00) non-bedtime up to and including 4 days postoperatively on the ICU and nursing ward is examined. From previous research in a similar population, it was observed that a relative rate of lying in bed of 60% is measured on day 1 after discharge from ICU, with a decrease of 6.5% per day (p < 0.001). Assuming a reduction on day 1 to 50%, the medium f2 effect size of 0.5 with a linear mixed model, two-sided testing, alpha of 0.05, power of 0.80 and two predictors (time and group), results in 14 patients needed per group.

The highest number of patients will be retained, i.e. 77 patients per group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: March 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• >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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Physical Inactivity
• Quality of Life
• Sternotomy
• Surgery

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Netherlands	Thoraxcentrum Twente	Enschede	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
Medisch Spectrum Twente	Foothills Medical Centre

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

Adams J, Lotshaw A, Exum E, Campbell M, Spranger CB, Beveridge J, Baker S, McCray S, Bilbrey T, Shock T, Lawrence A, Hamman BL, Schussler JM. An alternative approach to prescribing sternal precautions after median sternotomy, "Keep Your Move in the Tube". Proc (Bayl Univ Med Cent). 2016 Jan;29(1):97-100. doi: 10.1080/08998280.2016.11929379. — View Citation

Halfwerk FR, van Haaren JHL, Klaassen R, van Delden RW, Veltink PH, Grandjean JG. Objective Quantification of In-Hospital Patient Mobilization after Cardiac Surgery Using Accelerometers: Selection, Use, and Analysis. Sensors (Basel). 2021 Mar 11;21(6):1979. doi: 10.3390/s21061979. — View Citation

Holloway C, Pathare N, Huta J, Grady D, Landry A, Christie C, Pierce P, Bopp C. The Impact of a Less Restrictive Poststernotomy Activity Protocol Compared With Standard Sternal Precautions in Patients Following Cardiac Surgery. Phys Ther. 2020 Jul 19;100(7):1074-1083. doi: 10.1093/ptj/pzaa067. — View Citation

Park L, Coltman C, Agren H, Colwell S, King-Shier KM. "In the tube" following sternotomy: A quasi-experimental study. Eur J Cardiovasc Nurs. 2021 Feb 1;20(2):160-166. doi: 10.1177/1474515120951981. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperative to start of cardiac rehabilitation (4-6 weeks postoperatively)
Primary	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.	Postoperative day 0 to postoperative day 4
Secondary	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.	Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Secondary	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.	Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Secondary	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.	Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Secondary	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.	Postoperative (directly after surgery, day 0) until hospital discharge (expected to be around postoperative day 5 to a maximum of 7 days)
Secondary	Composite endpoint of sternal refixation, superficial and deep sternal wounds for 30 days after surgery	Definitions according to Netherlands Heart Registration	30-days postoperative