An observational study in Sarcopenia and Cardiac Surgery, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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:
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.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 455 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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)
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
Other: No intervention (observational study)
No intervention (observational study)
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.
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.
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.
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.
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.
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.
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.
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.
Muscle quantity assessed by bio-electrical impedance (InBody 770s)
A muscle quantity of \<20kg for men and \<15kg for women confirms sarcopenia.
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.
Severity of sarcopenia assessed by short physical performance battery
A score of 8 or less on the SPPB indicates severe sarcopenia.
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.
Severity of sarcopenia assessed by 4m walking speed
A gait speed of 0.8m/s or less indicates severe sarcopenia.
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.
Severity of sarcopenia assessed by timed up-and-go test
A TUG of 20 seconds or more indicates severe sarcopenia.
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.
Medical history assessed from the patient medical record
Type of cardiac surgery, date of cardiac surgery, comorbidities
Time frame: 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
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
Hemoglobine, Creatinin, eGFR, Glucose, HbA1c, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CRP.
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
Age, height (cm), weight (kg), waist circumference (cm), hip circumference (cm)
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
Sex, marital status, children, smoking, employment status, education level
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
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.
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
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.
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
Short-Form 36 has a total score ranging from 0-100 with 100 representing the highest level of functioning.
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
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.
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.
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: After completion of the data collection and data processing
Access criteria: The data will be made available upon reasonable request
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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