SarcopeniaSTRONGNCT07908472
Sarcopenia and Training Outcomes in Post-cardiac Surgery Patients
An observational study of Sarcopenia and Cardiac Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The goal of this observational study is to assess the prevalence of sarcopenia and see whether the current care is sufficient to improve sarcopenia outcomes in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Cardiac Surgery
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Feb 2026to Jun 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: All patients who underwent cardiac surgery in UZ Leuven are eligible for participation if they fulfill the eligibility criteria and are willing to sign informed consent
Who may be able to join
- Hospitalized following cardiac surgery (i.e. hospitalization unit 18 and 22)
- Stable with regard to symptoms
- Eligible for cardiac rehabilitation according to current guidelines following hospital discharge
- Voluntary written informed consent of the participant has been obtained
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
Who cannot join
- Not eligible for cardiac rehabilitation according to current guidelines
- Unable to perform the physical performance test due to physical or mental issues as up to decision by supervising cardiologist
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Véronique Cornelissen, +3316329152, veronique.cornelissen@kuleuven.be
Jomme Claes
About this study
Official title: Sarcopenia After Cardiac Surgery: An Overlooked Target for Therapeutic Optimization?
The goal of this observational study is to assess the prevalence of sarcopenia and see whether the current care is sufficient to improve sarcopenia outcomes in patients after cardiac surgery. The main questions it aims to answer are:
How prevalent is sarcopenia after cardiac surgery? Is the current standard of care sufficient to improve sarcopenia outcomes after cardiac surgery?
Participants will:
- Perform test to assess sarcopenia one day before leaving the hospital
- Perform these tests again after 4 weeks, 16 weeks, and/or 1 year depending on their sarcopenia status at baseline and whether or not they will follow a cardiac rehabilitation program
Read the detailed description
The 2021 ESC guidelines for the prevention and treatment of cardiovascular diseases in clinical practice emphasize the importance of proper screening and management of sarcopenia. Sarcopenia is defined as a progressive and generalized skeletal muscle disorder characterized by accelerated loss of muscle mass and function, which is associated with various adverse outcomes including falls, fractures, functional decline, and increased mortality. Although sarcopenia has traditionally been regarded as an age-related syndrome (primary sarcopenia), the condition is not exclusive to older populations. Increasingly, sarcopenia is being identified in younger individuals suffering from specific or multiple chronic diseases (secondary sarcopenia).
Secondary sarcopenia is particularly relevant in patients with cardiovascular disease. For example, in a study done in China, 78 (22.6%) out of the 345 enrolled participants who were hospitalized for coronary heart disease were found to have sarcopenia. Even higher prevalence rates were observed in Brazil where 64.6% and 35.4% of the 99 elderly patients with myocardial infarction presented with sarcopenia and sarcopenic obesity, respectively. Unlike the slow progression observed in primary sarcopenia, secondary sarcopenia can develop acutely, for instance within days following an acute hospital admission, leading to rapid deterioration of muscle mass and function. Acute sarcopenia, lasting <6 months, is typically related to acute illness, injury or hospitalization, and is reversible if appropriate treatment (e.g., exercise, nutrition) is initiated in a timely manner.
Nevertheless, sarcopenia remains frequently underrecognized in current clinical practice among patients recovering from cardiac surgery. Traditional cardiovascular risk assessment does not account for sarcopenia or frailty, instead relying on age and comorbidities as indirect measures. Consequently, sarcopenia is often underdiagnosed. This lack of awareness results in many patients with sarcopenia not being identified in a timely manner, thereby missing opportunities for early and effective intervention.
Further, little is known about the trajectory of sarcopenia during the recovery process following cardiac surgery. While sarcopenia is increasingly recognized as a relevant prognostic factor in cardiac surgical patients, most available research focuses on its prevalence and cross-sectional associations at single time points, often preoperatively or in the early postoperative phase. The changes in muscle mass, strength, and function throughout the rehabilitation period remain poorly characterized.
Understanding the determinants and temporal evolution of sarcopenia in this patient population is of clinical importance for several reasons. First, the postoperative period is characterized by multiple interacting factors that can accelerate or mitigate acute muscle loss, including systemic inflammation, immobilization, nutritional status, metabolic changes, and the presence of comorbidities, leading to acute secondary sarcopenia. Second, the recovery trajectory after cardiac surgery varies between individuals, suggesting that the risk and reversibility of sarcopenia may differ over time. Third, there is currently little understanding of the key predictors of sarcopenia progression or recovery over time. Though, this knowledge would enable the development of early, targeted, and personalized interventions aimed at preserving or restoring muscle mass and function, ultimately improving functional outcomes, quality of life, and long-term prognosis.
Finally, at UZ Leuven, approximately 447 patients eligible for cardiac rehabilitation currently enroll in the program on a yearly basis (data from 2023). The percentage of patients with sarcopenia among this group of patients is unknown. This multidisciplinary program has consistently demonstrated substantial benefits in improving exercise capacity, with mean increases in peak oxygen uptake (VO₂peak) of 20%. However, it remains to be investigated whether the current rehabilitation program is sufficient to improve muscle mass and muscle function in patients with sarcopenia, or whether these patients require a more tailored approach. Given that sarcopenia involves both quantitative and qualitative deficits in skeletal muscle, and that improvements in aerobic capacity do not necessarily translate into parallel gains in muscle mass or strength, it is plausible that the current rehabilitation may be suboptimal for this subgroup. Addressing this knowledge gap is essential to ensure that rehabilitation strategies are not only effective in enhancing cardiorespiratory fitness but also in reversing or mitigating sarcopenia, thereby maximizing overall functional recovery and long-term prognosis.
- Conditions
- Sarcopenia, Cardiac Surgery
- Being tested
- No intervention (observational study)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation in UZ Leuven | This cohort contains patients who will follow cardiac rehabilitation in UZ Leuven and will be followed-up at 4 weeks (start of CR), 16 weeks (end of CR) and 1 year after their cardiac surgery Receives: Other: No intervention (observational study) | |
| Cardiac rehabilitation not in UZ Leuven | This cohort contains patients who will follow cardiac rehabilitation elsewhere and will be followed-up at 1 year after their cardiac surgery Receives: Other: No intervention (observational study) | |
| No cardiac rehabilitation | These patients will not follow any formal phase II ambulatory cardiac rehabilitation program. They might follow some physiotherapy sessions in a private practice. Depending on sarcopenia status at the end of their hospital stay they will be followed after 1 year (if no sarcopenia present) or after 4 weeks, 16 weeks, and 1 year (if sarcopenia present) Receives: Other: No intervention (observational study) | |
| Baseline data only | These patients consent with the baseline testing during their hospitalization after cardiac surgery and also with the use of their data to answer our first research question (What is the prevalence of sarcopenia after cardiac surgery?), but explicitly indicated that they would not partake in any further testing, independent of the presence of sarcopenia or the location of their rehabilitation Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with sarcopenia at different stages of rehabilitation after cardiac surgery as assessed by EWGSOP2-criteria
The EWGSOP-criteria offer an algorithm for case finding, diagnosing and quantifying severity of sarcopenia. The SARC-F questionnaire is used to find cases. Muscle strength is tested to assess sarcopenia. Muscle quantity is assessed to confirm sarcopenia, and lastly, functional tests are used to determine the severity of sarcopenia. All criteria are included below.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Screening for the presence of sarcopenia by the SARC-F questionnaire
SARC-F stands for Strength, Assistance in walking, Rise from a chair, Climb stairs, Falls. It can have a score between 0 and 10, with a score of 4 or more indicating the patient should receive deeper diagnostic screening.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Handgrip strength assessed with a handheld dynamometer
A handgrip strength in the dominant hand of <27kg for men and <16kg for women indicates the possible presence of sarcopenia.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Lower body strength assessed by the 5x sit-to-stand test
A 5x sit-to-stand test >15 seconds for both sexes indicates the possible presence of sarcopenia.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Muscle quantity assessed by bio-electrical impedance (InBody 770s)
A muscle quantity of <20kg for men and <15kg for women confirms sarcopenia.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Severity of sarcopenia assessed by short physical performance battery
A score of 8 or less on the SPPB indicates severe sarcopenia.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Severity of sarcopenia assessed by 4m walking speed
A gait speed of 0.8m/s or less indicates severe sarcopenia.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Severity of sarcopenia assessed by timed up-and-go test
A TUG of 20 seconds or more indicates severe sarcopenia.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Secondary outcomes (9)
Medical history assessed from the patient medical record
Type of cardiac surgery, date of cardiac surgery, comorbidities
Measured: At baseline
Medication assessed from the patient medical record
Cardiovascular medication, anticoagulans, antidiabetic, lipid lowering, antiarrhythmic, other. All medications will be recorded as class of medication, generic name, brand name, dosage, and frequency
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Blood sampling assessed from the patient medical record
Hemoglobine, Creatinin, eGFR, Glucose, HbA1c, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CRP.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Anthropometrics
Age, height (cm), weight (kg), waist circumference (cm), hip circumference (cm)
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Demographics assessed by anamnesis
Sex, marital status, children, smoking, employment status, education level
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Physical activity level as assessed by the IPAQ-SF
International physical activity questionnaire short form (IPAQ-SF), a continuous scale expressed as MET-min/week with higher values representing higher levels of physical activity.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Diet and nutritional status as assessed by the MEDAS and MNA questionnaires
Mediterranean Diet Adherence Screener (MEDAS) and Mini Nutritional Assessment (MNA). A score of 7 or more (out of 12) on the MEDAS indicates modest accordance and a score of 9 or more strict accordance. The MNA has a maximum of 30 points with <17 indicating malnourishment, 17 to 23.5 indicating a risk of malnourishment and 24 to 30 normal nutritional status.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Quality of life as assessed by the SF-36 questionnaire
Short-Form 36 has a total score ranging from 0-100 with 100 representing the highest level of functioning.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Anxiety and depression assessed by the HADS questionnaire
Hospital Anxiety and Depression Scale (HADS) is a scale with 7 questions relating to anxiety and 7 questions relating to depression. Both subscales have a maximum score of 21, with a score of 0-7 indicating no symptoms, 8-10 mild symptoms and >10 moderate to severe symptoms.
Measured: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start5 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908472
- Sponsor's protocol ID
- S71264
- Acronym
- STRONG
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Transfer of the pseudonymized data will be performed via a secured method of transfer taking into account all applicable security arrangements and regulations (such as the European General Data Protection Regulation). The receiving party will be bound by contractual agreement to keep the transferred data confidential at all times and to only process the data for the purpose of the Trial. To this end, appropriate Data Transfer Agreements (DTAs) will be established.
Publications
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Cornelissen V, Hanssen H, Hurst C, Knaier R, Marques-Sule E, Moholdt T, Neunhaeuserer D, Norman K, Pedretti R, Salzwedel A, Savonen K, Bowen TS. Influence of exercise and nutrition on sarcopenia in cardiovascular disease: a Scientific Statement of the European Association of Preventive Cardiology of the European Society of Cardiology. Eur J Prev Cardiol. 2026 Sep 8;33(12):2105-2126. doi: 10.1093/eurjpc/zwaf432.
PubMed 40663695
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia After Cardiac Surgery: An Overlooked Target for Therapeutic Optimization?
- ClinicalTrials.gov ID
- NCT07908472
- Acronym / sponsor ID
- STRONG / S71264
- Conditions
- Sarcopenia, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Nov 2026 (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 observational study is to assess the prevalence of sarcopenia and see whether the current care is sufficient to improve sarcopenia outcomes in patients after cardiac surgery. The main questions it aims to answer are:
How prevalent is sarcopenia after cardiac surgery? Is the current standard of care sufficient to improve sarcopenia outcomes after cardiac surgery?
Participants will:
- Perform test to assess sarcopenia one day before leaving the hospital
- Perform these tests again after 4 weeks, 16 weeks, and/or 1 year depending on their sarcopenia status at baseline and whether or not they will follow a cardiac rehabilitation program
Detailed description
The 2021 ESC guidelines for the prevention and treatment of cardiovascular diseases in clinical practice emphasize the importance of proper screening and management of sarcopenia. Sarcopenia is defined as a progressive and generalized skeletal muscle disorder characterized by accelerated loss of muscle mass and function, which is associated with various adverse outcomes including falls, fractures, functional decline, and increased mortality. Although sarcopenia has traditionally been regarded as an age-related syndrome (primary sarcopenia), the condition is not exclusive to older populations. Increasingly, sarcopenia is being identified in younger individuals suffering from specific or multiple chronic diseases (secondary sarcopenia).
Secondary sarcopenia is particularly relevant in patients with cardiovascular disease. For example, in a study done in China, 78 (22.6%) out of the 345 enrolled participants who were hospitalized for coronary heart disease were found to have sarcopenia. Even higher prevalence rates were observed in Brazil where 64.6% and 35.4% of the 99 elderly patients with myocardial infarction presented with sarcopenia and sarcopenic obesity, respectively. Unlike the slow progression observed in primary sarcopenia, secondary sarcopenia can develop acutely, for instance within days following an acute hospital admission, leading to rapid deterioration of muscle mass and function. Acute sarcopenia, lasting <6 months, is typically related to acute illness, injury or hospitalization, and is reversible if appropriate treatment (e.g., exercise, nutrition) is initiated in a timely manner.
Nevertheless, sarcopenia remains frequently underrecognized in current clinical practice among patients recovering from cardiac surgery. Traditional cardiovascular risk assessment does not account for sarcopenia or frailty, instead relying on age and comorbidities as indirect measures. Consequently, sarcopenia is often underdiagnosed. This lack of awareness results in many patients with sarcopenia not being identified in a timely manner, thereby missing opportunities for early and effective intervention.
Further, little is known about the trajectory of sarcopenia during the recovery process following cardiac surgery. While sarcopenia is increasingly recognized as a relevant prognostic factor in cardiac surgical patients, most available research focuses on its prevalence and cross-sectional associations at single time points, often preoperatively or in the early postoperative phase. The changes in muscle mass, strength, and function throughout the rehabilitation period remain poorly characterized.
Understanding the determinants and temporal evolution of sarcopenia in this patient population is of clinical importance for several reasons. First, the postoperative period is characterized by multiple interacting factors that can accelerate or mitigate acute muscle loss, including systemic inflammation, immobilization, nutritional status, metabolic changes, and the presence of comorbidities, leading to acute secondary sarcopenia. Second, the recovery trajectory after cardiac surgery varies between individuals, suggesting that the risk and reversibility of sarcopenia may differ over time. Third, there is currently little understanding of the key predictors of sarcopenia progression or recovery over time. Though, this knowledge would enable the development of early, targeted, and personalized interventions aimed at preserving or restoring muscle mass and function, ultimately improving functional outcomes, quality of life, and long-term prognosis.
Finally, at UZ Leuven, approximately 447 patients eligible for cardiac rehabilitation currently enroll in the program on a yearly basis (data from 2023). The percentage of patients with sarcopenia among this group of patients is unknown. This multidisciplinary program has consistently demonstrated substantial benefits in improving exercise capacity, with mean increases in peak oxygen uptake (VO₂peak) of 20%. However, it remains to be investigated whether the current rehabilitation program is sufficient to improve muscle mass and muscle function in patients with sarcopenia, or whether these patients require a more tailored approach. Given that sarcopenia involves both quantitative and qualitative deficits in skeletal muscle, and that improvements in aerobic capacity do not necessarily translate into parallel gains in muscle mass or strength, it is plausible that the current rehabilitation may be suboptimal for this subgroup. Addressing this knowledge gap is essential to ensure that rehabilitation strategies are not only effective in enhancing cardiorespiratory fitness but also in reversing or mitigating sarcopenia, thereby maximizing overall functional recovery and long-term prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation in UZ Leuven | – | Other: No intervention (observational study)This cohort contains patients who will follow cardiac rehabilitation in UZ Leuven and will be followed-up at 4 weeks (start of CR), 16 weeks (end of CR) and 1 year after their cardiac surgery |
| Cardiac rehabilitation not in UZ Leuven | – | Other: No intervention (observational study)This cohort contains patients who will follow cardiac rehabilitation elsewhere and will be followed-up at 1 year after their cardiac surgery |
| No cardiac rehabilitation | – | Other: No intervention (observational study)These patients will not follow any formal phase II ambulatory cardiac rehabilitation program. They might follow some physiotherapy sessions in a private practice. Depending on sarcopenia status at the end of their hospital stay they will be followed after 1 year (if no sarcopenia present) or after 4 weeks, 16 weeks, and 1 year (if sarcopenia present) |
| Baseline data only | – | Other: No intervention (observational study)These patients consent with the baseline testing during their hospitalization after cardiac surgery and also with the use of their data to answer our first research question (What is the prevalence of sarcopenia after cardiac surgery?), but explicitly indicated that they would not partake in any further testing, independent of the presence of sarcopenia or the location of their rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent cardiac surgery in UZ Leuven are eligible for participation if they fulfill the eligibility criteria and are willing to sign informed consent
Key inclusion criteria (5 listed)
- Hospitalized following cardiac surgery (i.e. hospitalization unit 18 and 22)
- Stable with regard to symptoms
- Eligible for cardiac rehabilitation according to current guidelines following hospital discharge
- Voluntary written informed consent of the participant has been obtained
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
Key exclusion criteria (2 listed)
- Not eligible for cardiac rehabilitation according to current guidelines
- Unable to perform the physical performance test due to physical or mental issues as up to decision by supervising cardiologist
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 |
|---|---|---|
| No intervention (observational study)No intervention (observational study) | Other | Baseline data only, Cardiac rehabilitation in UZ Leuven, Cardiac rehabilitation not in UZ Leuven, No cardiac rehabilitation |
Primary outcome
Proportion of patients with sarcopenia at different stages of rehabilitation after cardiac surgery as assessed by EWGSOP2-criteria
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
The EWGSOP-criteria offer an algorithm for case finding, diagnosing and quantifying severity of sarcopenia. The SARC-F questionnaire is used to find cases. Muscle strength is tested to assess sarcopenia. Muscle quantity is assessed to confirm sarcopenia, and lastly, functional tests are used to determine the severity of sarcopenia. All criteria are included below.
Screening for the presence of sarcopenia by the SARC-F questionnaire
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
SARC-F stands for Strength, Assistance in walking, Rise from a chair, Climb stairs, Falls. It can have a score between 0 and 10, with a score of 4 or more indicating the patient should receive deeper diagnostic screening.
Handgrip strength assessed with a handheld dynamometer
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
A handgrip strength in the dominant hand of <27kg for men and <16kg for women indicates the possible presence of sarcopenia.
Lower body strength assessed by the 5x sit-to-stand test
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
A 5x sit-to-stand test >15 seconds for both sexes indicates the possible presence of sarcopenia.
Muscle quantity assessed by bio-electrical impedance (InBody 770s)
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
A muscle quantity of <20kg for men and <15kg for women confirms sarcopenia.
Severity of sarcopenia assessed by short physical performance battery
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
A score of 8 or less on the SPPB indicates severe sarcopenia.
Severity of sarcopenia assessed by 4m walking speed
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
A gait speed of 0.8m/s or less indicates severe sarcopenia.
Severity of sarcopenia assessed by timed up-and-go test
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
A TUG of 20 seconds or more indicates severe sarcopenia.
9 secondary outcomes
Medical history assessed from the patient medical record
Time frame: At baseline
Medication assessed from the patient medical record
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Blood sampling assessed from the patient medical record
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Anthropometrics
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Demographics assessed by anamnesis
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Physical activity level as assessed by the IPAQ-SF
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Diet and nutritional status as assessed by the MEDAS and MNA questionnaires
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Quality of life as assessed by the SF-36 questionnaire
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
Anxiety and depression assessed by the HADS questionnaire
Time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.
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 2 Nov 2026.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 40663695Cornelissen V, Hanssen H, Hurst C, Knaier R, Marques-Sule E, Moholdt T, Neunhaeuserer D, Norman K, Pedretti R, Salzwedel A, Savonen K, Bowen TS. Influence of exercise and nutrition on sarcopenia in cardiovascular disease: a Scientific Statement of the European Association of Preventive Cardiology of the European Society of Cardiology. Eur J Prev Cardiol. 2026 Sep 8;33(12):2105-2126. doi: 10.1093/eurjpc/zwaf432.
- Individual participant dataSharing planned: Yes. Transfer of the pseudonymized data will be performed via a secured method of transfer taking into account all applicable security arrangements and regulations (such as the European General Data Protection Regulation). The receiving party will be bound by contractual agreement to keep the transferred data confidential at all times and to only process the data for the purpose of the Trial. To this end, appropriate Data Transfer Agreements (DTAs) will be established.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Cardiac Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 inclusion and 2 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 2 Nov 2026. 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 Belgium. 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 Véronique Cornelissen (+3216329152, veronique.cornelissen@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with sarcopenia at different stages of rehabilitation after cardiac surgery as assessed by EWGSOP2-criteria (time frame: 1 to 4 times (baseline, 4 weeks after surgery, 16 weeks after surgery, 1-year after surgery) during the follow-up period, depending on the cohort the patient is in.). The study lists 8 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 NCT07908472, which also lists 2 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 2 Nov 2026.