SternotomyT-REX TwenteNCT06115759
RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy
A study testing T-REX Twente precautions and Usual (restrictive) sternal precautions in people with Sternotomy and Cardiovascular Diseases, run by Medisch Spectrum Twente at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy, Cardiovascular Diseases, Physical Inactivity
- What is being tested?
- T-REX Twente precautions and Usual (restrictive) sternal precautions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 May 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- >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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Thoraxcentrum Twente
Enschede, Overijssel, 7500KA
Nicole Wielens, BSc, 0031615060570, n.wielens@mst.nl
Frank R Halfwerk, MD, PhD, f.halfwerk@mst.nl
About this study
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
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.
Read more
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).
Read the 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.
- Being tested
- T-REX Twente precautions, Usual (restrictive) sternal precautions
- Keywords
- Sternotomy, Cardiac Surgical Procedures, Cardiac Rehabilitation, Early Ambulation
- Medical subject headings
- Cardiovascular Diseases, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-REX Twente precautionsBehavioural
Also called 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
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 precautionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Usual (restrictive) sternal precautions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Postoperative day 0 to postoperative day 4
Secondary outcomes (5)
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.
Measured: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
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.
Measured: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
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.
Measured: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
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.
Measured: 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
Definitions according to Netherlands Heart Registration
Measured: 30-days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start21 May 2024
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SternotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Collaborators
- Foothills Medical Centre
- Responsible party
- Principal investigator, Frank Halfwerk, Medisch Spectrum Twente
- Investigators
- Frank R. Halfwerk, MD, PhD, Principal investigator, Medisch Spectrum Twente, Enschede, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115759
- Sponsor's protocol ID
- T-REX Twente
- Other IDs
- CCMO-ABR 78107, 56700
- Acronym
- T-REX Twente
- Status last verified
- Feb 2025
- First submitted
- 18 Oct 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is not yet known if there will be a plan to make individual participant data (IPD) available. Study protocol and statistical analysis plan might be published.
Publications
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.
PubMed 33799717Adams 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.
PubMed 26722187Park 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.
PubMed 33611341Holloway 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.
PubMed 32302408Wielens N, Roerdink K, Lynch W, Esau L, van der Palen J, Halfwerk FR. A randomized controlled study on the effects of the T-REX Twente (Thoracic Surgical Rehabilitation Experts Twente) sternal precautions on quality of life and physical activity levels in cardiac surgery patients, compared to standard care in patients following a median sternotomy: the study protocol. Trials. 2026 Jun 27. doi: 10.1186/s13063-026-09877-z. Online ahead of print.
PubMed 42365330
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06115759
- Acronym / sponsor ID
- T-REX Twente / T-REX Twente
- Keywords
- Sternotomy, Cardiac Surgical Procedures, Cardiac Rehabilitation, Early Ambulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Collaborators
- Foothills Medical Centre
- Study start
- 21 May 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-REX Twente | Experimental | Behavioral: T-REX Twente precautionsThe 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 | Active comparator | Behavioral: Usual (restrictive) sternal precautionsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-REX Twente precautionsAlso: The T-REX Twente precautions are inspired on the Keep Your Move in the Tube (KYMITT) principle, and adjusted and improved to our local settingThe 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). | Behavioural | T-REX Twente |
| Usual (restrictive) sternal precautionsThe 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. | Behavioural | Usual care |
Primary outcome
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
Time frame: 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.
Not lying in bed
Time frame: 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.
5 secondary outcomes
Numeric (Pain) Rating Scale (NPRS)
Time frame: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI)
Time frame: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Tampa Scale for Kinesiophobia (TSK)
Time frame: Preoperative to end of cardiac rehabilitation (12 weeks postoperatively)
Individual mobilisation activities as measured with AX3 Accelerometer
Time frame: 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
Time frame: 30-days postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 33799717Halfwerk 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.
- Background: PubMed 26722187Adams 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.
- Background: PubMed 33611341Park 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.
- Background: PubMed 32302408Holloway 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.
- Derived from this study: PubMed 42365330Wielens N, Roerdink K, Lynch W, Esau L, van der Palen J, Halfwerk FR. A randomized controlled study on the effects of the T-REX Twente (Thoracic Surgical Rehabilitation Experts Twente) sternal precautions on quality of life and physical activity levels in cardiac surgery patients, compared to standard care in patients following a median sternotomy: the study protocol. Trials. 2026 Jun 27. doi: 10.1186/s13063-026-09877-z. Online ahead of print.
- Individual participant dataSharing planned: Yes. It is not yet known if there will be a plan to make individual participant data (IPD) available. Study protocol and statistical analysis plan might be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank R. Halfwerk, MD, PhD principal investigator
Medisch Spectrum Twente, Enschede, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-REX Twente precautions and Usual (restrictive) sternal precautions in people with Sternotomy and Cardiovascular Diseases, run by Medisch Spectrum Twente at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Wielens, BSc (0031615060570, n.wielens@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life after Myocardial Infarction Questionnaire (MacNew QLMI) (time frame: Preoperative to start of cardiac rehabilitation (4-6 weeks postoperatively)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06115759, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.