Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT06785168
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 60 years old
* Meet the diagnostic criteria of 2019 AWGS2 sarcopenia, can be diagnosed once meeting (1) + (2) or (1) + (3) or (1) + (2) + (3): (1) Appendicular skeletal muscle mass (ASM): dual-energy X-ray absorptiometry (DXA) (male \<7.0 kg/m², female \<5.7 kg/m²). (2) Muscle strength: handgrip strength (male \<28.0 kg, female \<18.0 kg). (3) Physical performance: 6-meter walking speed \<1.0 m/s.
* Meet the diagnostic criteria of heart failure following ESC 2021.
* Clearly understand the content and purpose of the study and sign the informed consent form.
Exclusion Criteria: There are contraindications for Exercise Testing in patients with stable heart failure according to ACSM 2022:
* Early stage after acute coronary syndrome (within the first 2 days)
* Unstable coronary artery disease
* Decompensated heart failure
* Acute venous thrombosis or recent arterial embolism (pulmonary or systemic)
* Acute myocarditis, pericarditis, endocarditis
* Aortic dissection of the valve
* Severe symptomatic aortic stenosis
* Acute systemic disease or fever
* Uncontrolled or life-threatening atrial or ventricular arrhythmias (including new-onset atrial fibrillation or flutter)
* Uncontrolled tachycardia (resting heart rate \> 120 beats per minute)
* Third-degree AV block
* Uncontrolled diabetes
* Symptomatic orthostatic hypotension (\> 20 mmHg)
* Gradually increasing fatigue during exercise or dyspnea at rest or with exertion within the past 3-5 days
* Significant myocardial ischemia at low workloads \< 2 METs or 50W
* Relative contraindications according to ACSM 2022:
* Weight gain ≥ 1.8 kg in the past 1-3 days
* Simultaneous use of continuous or intermittent Dobutamine
* Decrease in blood pressure with exercise
* NYHA IV heart failure
* Complex ventricular arrhythmias at rest or with exertion
* Resting heart rate ≥ 100 bpm when lying down
* Comorbidities that limit exercise
* Severe obstructive hypertrophic cardiomyopathy
* Have participated in a cardiovascular rehabilitation program within the last 6 months
* Do not agree to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06785168
Study Brief:
Protocol Section:
NCT06785168