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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07485218
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 65 years.
Exclusion Criteria:
* No understanding of the project language (Italian);
* Moderate to severe dementia, with a Short Portable Mental Status Questionnaire (SPMSQ) score ≥1 \[Pfeiffer, 1975\] or Cognitive Performance Scale (CPS) ≥3 \[Morris et al., 1994\];
* Psychiatric disorders and moderate neurodegenerative diseases;
* Delirium;
* Persistent infections;
* Inability to follow the study procedures (due to psychological disorders or dementia);
* Severe hearing problem;
* Unable or refuse to perform the physical tests (maximal handgrip strength, leg extension);
* Severe cardiovascular and lung diseases (acute infection, heart, or lung failure, unstable angina and myocardial infarction during the previous month);
* Renal failure, hepatic dysfunction;
* Recent major surgery;
* Severe cardiovascular exacerbations (RR \> 240/120, HR above the age predicted maximum of 220-Age);
* Participation in another study with investigational drug within the 30 days preceding and during the present study;
* Drug treatments that may interfere with the fatigue level;
* Lifestyle factors and / or persistent addictions (drug or alcohol abuse).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07485218
Study Brief:
Protocol Section:
NCT07485218