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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT03540732
Eligibility Criteria:
Inclusion Criteria:
1. At least 60 years old
2. Mechanically ventilated within 3 days of ICU admission
3. Expected to be mechanically ventilated for more than 3 days at time of recruitment
4. Able to ambulate with or without a gait aid before hospitalization
5. Able to be enterally fed within 48 hours of ICU admission
Exclusion Criteria:
1. Unable to follow commands at baseline before hospital admission (e.g. Severe dementia)
2. Acute condition where cycling is a contraindication (e.g. leg fracture)
3. Not expected to survive the subsequent 48 hours
4. Body habitus unable to fit the cycle ergometry
5. Patients at high risk of refeeding (i.e. NUTRIC score \>= 5): malnourished patients with anorexia nervosa, chronic malabsorption syndromes, chronic alcoholism, or patients with massive weight loss.
6. Extremes of BMI: i.e. BMI \< 16 or \> 30
7. Liver failure
8. Cycling exemptions precluding cycling within the first 4 days of mechanical ventilation
9. Requirement for inspired oxygen content (FiO2) greater than 0.8
10. Expected to be on renal replacement therapy for longer than 12 hours per session
11. PEEP \> 15mmHg
12. Air leaks through chest drains
13. Palliative goals of care or limitation of treatment established by the CARE form
14. Readmissions to ICU
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03540732
Study Brief:
Protocol Section:
NCT03540732