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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT02421393
Eligibility Criteria:
Inclusion Criteria:
* diabetes duration \>5-year
* sedentary lifestyle (i.e. more than 8 hours/day spent in any waking behavior characterized by an energy expenditure ≤1.5 metabolic equivalents \[METs\] while in a sitting or reclining posture) from at least 6 months;
* physically inactivity (i.e. insufficient amounts of physical activity \[PA\] according to current guidelines) from at least 6 months;
* body mass index (BMI) 27-40 kg/m2;
* ability to walk 1.6 Km without assistance;
* a Short Battery Performance Test score ranging from 4 to 9;
* eligibility after cardiologic evaluation.
Exclusion Criteria:
* any condition limiting participation in a clinical trial, including psychiatric disorders or hospitalization for depression in the past 6 months;
* any condition limiting PA/exercise, including musculoskeletal disorders or deformities, central nervous system dysfunction such as hemiparesis, myelopathies, cerebral ataxia, vestibular dysfunction, and postural hypotension (i.e. a fall of \>20 mmHg of systolic or \>10 mmHg of diastolic blood pressure when changing position);
* cancer and other life-expectancy limiting conditions;
* recent major acute cardiovascular event, including heart attack, stroke/transient ischemic attack(s), revascularization procedure, or participation in a cardiac rehabilitation program within the past three months, or documented history of pulmonary embolism in the past six months;
* pre-proliferative and proliferative retinopathy;
* macroalbuminuria and/or estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2;
* ankle/brachial index (ABI) \<0.9;
* severe motor and sensory neuropathy;
* diabetic foot with history of ulcer;
* hemoglobin (Hb) A1c \>9.0%;
* blood pressure (BP) \>150/90 mmHg;
* vitamin D \<10 ng/ml;
* treatment with anti-fracturative agents, estrogens, aromatase inhibitors, testosterone, corticosteroids and/or glitazon;
* previous documented non-traumatic fractures,
* total spine deformity index (SDI) \>3 (and \>1 in a single vertebra);
* a T score \<-2.5 at spine/hip at dual-energy X-ray absorptiometry (DXA). Subjects with HbA1c or blood pressure above the indicated threshold will be receive appropriate treatment and will be re-evaluated after 3 months. Patients with vitamin D levels \< 10 ng/dl will be treated with cholecalciferol 25.000 IU/week for 6 weeks and will be re-evaluated for eligibility 2 weeks after the last
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
75 Years
Study:
NCT02421393
Study Brief:
Protocol Section:
NCT02421393