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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT04818359
Eligibility Criteria:
Inclusion criteria:
1. Diagnosis of BC (stage 0-II-III, without metastases or recurrences diagnosis at recruitment).
2. After surgery and chemotherapy and/or radiotherapy treatments.
3. Maximum 12 months from surgical treatment.
4. Minimum 6 months from the end of chemotherapy.
5. Risk of recurrence will be identified with meeting at least 1 of the following criteria: BMI at diagnosis ≥ 25 kg/m2, testosterone ≥ 0.4 ng/mL (for women); serum insulin ≥ 25 µU/mL (170 pmol/L); metabolic syndrome (at least 3 of the following 5 factors): a. glycemia ≥ 100 mg/dL (6.05 mmol/L); b. triglycerides ≥150 mg/dL (1.69 mmol L); c. HDL-C \<50 mg/dL (1.29 mmol/L) (woman), \<40 mg/dL (1.04 mmol/L) (man); d. waist circumference ≥ 80 cm (woman), ≥ 90 cm (man); e. blood pressure ≥ 130/85 mmHg.
6. Non-physically active: subjects who were not regularly active (assessed by IPAQ) for at least 6 months.
Exclusion criteria:
1. Not suitable for non-competitive physical activity after the cardiological medical examination.
2. Disabling pneumological, cardiological, neurological, orthopedic comorbidities and mental illness that prevent the exercise performance.
3. Treatment with drugs that alter the heart rate response to exercise.
4. Treatment with antidepressant drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT04818359
Study Brief:
Protocol Section:
NCT04818359