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 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT04179903
Eligibility Criteria:
Inclusion Criteria:
* signed informed consent
* post menopausal women aged \>40 years (with or without history of fractures, with or without pharmacological therapy for OP)
* lumbar spine or femur T-score ≤-2,5
* functional motor capacity normal or moderately reduced (Short Physical Performance Battery)
* sedentary life style (having exercised less than 30 minutes per week in the last 6 months).
Exclusion Criteria are:
* secondary OP49, impairment of communicative and/or sensorial functions so severe to make impossible understanding or executing trainer's instructions (dementia, aphasia, blindness, deafness);
* heart failure (NYHA class \>2);
* unstable angina, pulmonary disease requiring oxygen therapy;
* symptomatic peripheral arteriopathy;
* myocardial infarction or hospital admission in the previous 6 months,
* symptomatic orthostatic hypotension;
* hypertension in poor pharmacologic control (diastolic \>95 mmHg, systolic \>160 mmHg),
* previous implant of prosthesis at upper or lower limbs,
* relevant neurological condition impairing motor or cognitive function, any other condition that the medical doctor (MD) considers to contraindicate the participation in an exercise program of moderate intensity.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT04179903
Study Brief:
Protocol Section:
NCT04179903