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 @ 5:59 PM
Ignite Modification Date:
2025-12-24 @ 5:59 PM
NCT ID:
NCT04504968
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged ≥ 65 years.
* The subject is willing and able to give written informed consent for participation in the study.
* Diagnosis of type 2 diabetes for at least 2 years
* Require to fulfill Fried´s criteria for frail or pre-frail individuals
Exclusion Criteria:
* Unable or unwilling to provide informed consent or accept randomization to either study group
* Plans to relocate out of the study area within the year or plans to be out of the study area for more than 6 consecutive weeks in the next year
* MoCA (Montreal Cognitive Assessment) lower than 17/30
* Cancer requiring treatment in the past 3 years,except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer)
* Barthel ADL score lower than 60 points
* Inability to carry out the SPPB test (total score = 0)
* Upper and/or lower extremity amputation
* Current participation in a structured physical activity (PA) program, physical therapy or cardiopulmonary rehabilitation
* Current enrolment in another randomized clinical trial (RCT) involving lifestyle, nutrition, or pharmaceutical interventions
* Other medical, psychiatric, or behavioral factors that in the judgment of the investigator may interfere with the study participation
* Other illness of such severity that life expectancy is expected to be less than 12 months
* Any other condition that is an absolute contraindication to the exercise program:
* Acute heart attack (recent 3-6 months) or unstable angina
* Uncontrolled atrial or ventricular arrhythmias
* Aortic dissecting aneurysm
* Severe aortic stenosis
* Acute endocarditis / pericarditis
* Uncontrolled high blood pressure (\> 180/100 mmHg)
* Acute thromboembolism
* Acute or severe heart failure
* Acute or severe respiratory failure
* Uncontrolled postural hypotension
* Uncontrolled acute decompensated diabetes mellitus or low blood sugar
* A recent fracture in the last month Any other circumstance the investigator believes to prevent undertaking physical activity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04504968
Study Brief:
Protocol Section:
NCT04504968