Status:
UNKNOWN
Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican
Lead Sponsor:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborating Sponsors:
Pan American Health Organization
Catholic University of the Sacred Heart
Conditions:
Frailty Syndrome
Frail Elderly Syndrome
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Randomized clinical trial, international, multicentre, single-blind, two parallel groups, pragmatic. It will be carried out by investigators in several Latin American countries (Chile, Colombia, Mexic...
Detailed Description
International, multicentre, single-blind, two parallel groups, pragmatic randomised Research Clinical Trial. It will be carried out by investigators in several Latin American countries (Chile, Colombi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
713 Patients enrolled
Trial Details
Trial ID
NCT04504968
Start Date
February 14 2022
End Date
May 31 2024
Last Update
August 31 2023
Active Locations (1)
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1
Hospital San Ignacio_Universidad Javeriana
Bogotá, Colombia, 11001