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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT06985550
Eligibility Criteria:
Inclusion Criteria:
1. Age: Postmenopausal women aged ≤65 years at the time of enrollment.
2. Menopausal Status: Natural menopause defined as spontaneous cessation of menstruation for ≥12 consecutive months, excluding menopause due to pathological or surgical causes (e.g., oophorectomy, thyroid disorders).
3. Dyslipidemia: Presence of one or more of the following lipid abnormalities:
High-density lipoprotein cholesterol (HDL-C) \< 1.04 mmol/L Triglycerides (TG) ≥ 1.7 mmol/L Low-density lipoprotein cholesterol (LDL-C) ≥ 3.0 mmol/L Total cholesterol (TC) ≥ 5.18 mmol/L
4. Obesity or Sarcopenic Tendency: Body fat percentage \> 30%, as measured by validated body composition analyzer.
5. Physical Capability: No musculoskeletal injuries, physical disabilities, or contraindications to exercise. Participants must be cleared using the Physical Activity Readiness Questionnaire (PAR-Q).
6. Sedentary Lifestyle: Engaging in structured physical activity ≤3 times per week, with each session lasting ≤20 minutes, in the last 6 months.
7. No Recent Weight Control Interventions: No use of weight-loss supplements or engagement in intentional weight loss through diet or exercise in the past year.
8. Voluntary Participation: Willingness to participate in the study and provide written informed consent (Informed Consent Form, ICF).
Exclusion Criteria:
1. Metabolic or Endocrine Disorders: History of insulin-dependent diabetes mellitus, untreated or unstable thyroid dysfunction, Cushing's syndrome, or other serious endocrine diseases.
2. Cardiovascular Disease: Uncontrolled hypertension, arrhythmias, congestive heart failure, or a history of myocardial infarction or stroke within the past 6 months.
3. Severe Respiratory Conditions: Chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, or any condition significantly limiting exercise tolerance.
4. Neurological Disorders: Parkinson's disease, post-stroke sequelae, moderate to severe cognitive impairment, or Alzheimer's disease.
5. Inflammatory or Autoimmune Diseases: Active rheumatoid arthritis, Crohn's disease, or other chronic inflammatory conditions.
6. Cancer: Diagnosis of any malignancy within the past 5 years.
7. Musculoskeletal Limitations: Diagnosed severe osteoporosis or a history of falls or fractures within the past 6 months.
8. Extremes of Body Mass Index (BMI): BMI ≥35 kg/m² or \<18.5 kg/m².
9. Substance Use: Current drug abuse, heavy alcohol consumption (defined as \>70 g alcohol/week), or heavy smoking (≥10 cigarettes/day) that cannot be reduced during the study period.
10. Dietary Extremes: Strict vegetarian, ketogenic, or other extreme dietary patterns that may affect metabolic outcomes.
11. Medications:
Current hormone replacement therapy (e.g., estrogen, testosterone). Use of antidepressants in the past 6 months. Regular use of medications affecting lipid metabolism, bone health, or cardiovascular function (e.g., aspirin, statins, antihypertensive or antidiabetic drugs).
12. Recent Structured Exercise: Participation in structured dance, resistance, or agility training within the past 12 months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT06985550
Study Brief:
Protocol Section:
NCT06985550