Trial · NCT07908472
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients with sarcopenia at different stages of rehabilitation after cardiac surgery as assessed by EWGSOP2-criteria | 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. |
| Primary | Screening for the presence of sarcopenia by the SARC-F questionnaire | 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. |
| Primary | Handgrip strength assessed with a handheld dynamometer | 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. |
| Primary | Lower body strength assessed by the 5x sit-to-stand test | 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. |
| Primary | Muscle quantity assessed by bio-electrical impedance (InBody 770s) | 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. |
| Primary | Severity of sarcopenia assessed by short physical performance battery | 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. |
| Primary | Severity of sarcopenia assessed by 4m walking speed | 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. |
| Primary | Severity of sarcopenia assessed by timed up-and-go test | 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. |
| Secondary | Medical history assessed from the patient medical record | At baseline | Type of cardiac surgery, date of cardiac surgery, comorbidities |
| Secondary | Medication assessed from the patient medical record | 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. | Cardiovascular medication, anticoagulans, antidiabetic, lipid lowering, antiarrhythmic, other. All medications will be recorded as class of medication, generic name, brand name, dosage, and frequency |
| Secondary | Blood sampling assessed from the patient medical record | 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. | Hemoglobine, Creatinin, eGFR, Glucose, HbA1c, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, CRP. |
| Secondary | Anthropometrics | 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. | Age, height (cm), weight (kg), waist circumference (cm), hip circumference (cm) |
| Secondary | Demographics assessed by anamnesis | 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. | Sex, marital status, children, smoking, employment status, education level |
| Secondary | Physical activity level as assessed by the IPAQ-SF | 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. | 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. |
| Secondary | Diet and nutritional status as assessed by the MEDAS and MNA questionnaires | 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. | 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. |
| Secondary | Quality of life as assessed by the SF-36 questionnaire | 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. | Short-Form 36 has a total score ranging from 0-100 with 100 representing the highest level of functioning. |
| Secondary | Anxiety and depression assessed by the HADS questionnaire | 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. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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