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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT07048860
Eligibility Criteria:
Inclusion Criteria:
* Independent-living (ADL ≥5/6)
* Men and women
* Mobility impairment (5 Chair-rise test \>12 seconds)
* Sedentarism (spend six or more hours per day sitting or lying down)
* Positive screening for cognitive impairment according to the ICOPE screening tool with MMSE \[25-28\]
* BMI ≥25 kg/m2
Exclusion Criteria:
* Unintentional weight loss (≥10%) in past 6 months
* Dementia
* Life-threatening illnesses, with a life expectancy (judged by the investigating doctor) of less than 1 year
* Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina or any other contraindication to physical activity (as determined by a physician) or comorbid disease that would impair ability to participate in the ICOPE intense intervention such as renal failure on hemodialysis, severe psychiatric disorder (depressive participant will not be excluded)
* Organizational inability (three-time per week during the 60 days)
* Living in a Nursing-Home
* Under legal protection measure (guardianship, curatorship, safeguard of justice
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT07048860
Study Brief:
Protocol Section:
NCT07048860