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

NCT06115759 | Recruiting

• 3 other identifiers: T-REX TwenteCCMO-ABR 7810756700
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Sternotomy; Cardiac Surgical Procedures; Cardiac Rehabilitation; Early Ambulation

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• 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)

• Tampa Scale for Kinesiophobia (TSK)

  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)

• Composite endpoint of sternal refixation, superficial and deep sternal wounds for 30 days after surgery

  30-days postoperative

Study Arms (2)

T-REX Twente

EXPERIMENTAL

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).

Behavioral: T-REX Twente precautions

Usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual (restrictive) sternal precautions

Interventions

T-REX Twente precautions 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).

Also known as: 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

T-REX Twente

Usual (restrictive) sternal precautions 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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \>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

Sponsors & Collaborators

• Medisch Spectrum Twente: lead
• Foothills Medical Centre: collaborator

Study Sites (1)

Thoraxcentrum Twente

Enschede, Overijssel, 7500KA, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 7999757 BACKGROUND

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

  PMID: 4677872 BACKGROUND

• 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.

  PMID: 33611341 BACKGROUND

• 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.

  PMID: 32302408 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Frank R. Halfwerk, MD, PhD

  Medisch Spectrum Twente, Enschede, the Netherlands

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Wielens, BSc

CONTACT

0031615060570; n.wielens@mst.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Technical Medical Doctor in Cardio-Thoracic Surgery

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 3, 2023
• Study Start: May 21, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Protocol is expected to be submitted for publication in 2024
• Access Criteria: Principal Investigator generally supports Open Access publishing and data sharing.

Locations

NL (1)