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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04761367
Eligibility Criteria:
Inclusion Criteria:
Pre-surgery criteria
* Signed informed consent
* Age: 50-80 years
* Indications: Patient with unilateral advanced Osteo-Arthrosis (OA) requiring primary THR or TKR;
* General: American Society of Anesthesiologists (ASA) class 1 or 2
* Resident in Bologna metropolitan area
Post-surgery criteria
* Functional performance: Able to stand and walk \>500 meters independently;
* Pain: score ≤ 4 in VAS
Exclusion Criteria:
* Unable/unwilling to sign the informed consent form of the study and/or willing to comply with the study requests
* Poor knowledge of Italian language which prevents understanding of the content of the consent form and/or of instructions for assessment and/or training;
* Severe functional limitations of other lower extremity joints besides that for which surgery is planned;
* Impairment of communicative and/or sensory 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;
* Recent myocardial infarction or hospital admission for any other reason in the previous 6 months;
* Symptomatic orthostatic hypotension;
* Hypertension in poor pharmacologic control (diastolic \>95 mmHg, systolic \>160 mmHg);
* 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;
* Severe depression.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT04761367
Study Brief:
Protocol Section:
NCT04761367