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

NCT ID: NCT06115759

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2026-03-31

Brief 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).

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

T-REX Twente

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).

Group Type: EXPERIMENTAL

T-REX Twente precautions

Intervention Type: BEHAVIORAL

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 care

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.

Group Type: ACTIVE_COMPARATOR

Usual (restrictive) sternal precautions

Intervention Type: BEHAVIORAL

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

The T-REX Twente precautions are inspired on the Keep Your Move in the Tube (KYMITT) principle, and adjusted and improved to our local setting

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foothills Medical Centre

OTHER

Sponsor Role: collaborator

Medisch Spectrum Twente

OTHER

Sponsor Role: lead

Responsible Party

Frank Halfwerk

Assistant Professor and Technical Medical Doctor in Cardio-Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank R. Halfwerk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medisch Spectrum Twente, Enschede, the Netherlands

Locations

Thoraxcentrum Twente

Enschede, Overijssel, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nicole Wielens, BSc

Role: CONTACT

n.wielens@mst.nl

0031615060570

Facility Contacts

Nicole Wielens, BSc

Role: primary

n.wielens@mst.nl

0031615060570

Frank R Halfwerk, MD, PhD

Role: backup

f.halfwerk@mst.nl

References

Benning MM, Kuo JM, Raushel FM, Holden HM. Three-dimensional structure of phosphotriesterase: an enzyme capable of detoxifying organophosphate nerve agents. Biochemistry. 1994 Dec 20;33(50):15001-7. doi: 10.1021/bi00254a008.

Reference Type: BACKGROUND

PMID: 7999757 (View on PubMed)

Floch HA. [Leprosy in Guadeloupe]. Bull Soc Pathol Exot Filiales. 1972 Jan-Feb;65(1):35-46. No abstract available. French.

Reference Type: BACKGROUND

PMID: 4677872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33611341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32302408 (View on PubMed)

Other Identifiers

CCMO-ABR 78107

Identifier Type: OTHER

Identifier Source: secondary_id

56700

Identifier Type: OTHER

Identifier Source: secondary_id

T-REX Twente

Identifier Type: -

Identifier Source: org_study_id