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NCT04504968

Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican

Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER)

View on ClinicalTrials.gov

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, Mexico and Peru) and with random allocation 1:1 of the participants to Usual Care Group (UCG) or Intervention Group (IG). Each country will select 5 trial sites that will recruit 0-60 participants. Finally, 1050 subjects will be involved in the project. The primary outcome are the changes in function and quality of life as measured by changes in the scores used to assess them between baseline and 1-year follow-up. Function will be assessed by the Short Physical Performance Battery-SPPB. This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status The intervention includes: Educational program in small groups: 7 sessions in the clinical trial sites (2 sessions a week for the first 3-4 weeks) Exercise program (16 weeks): learning phases in clinical trial site for 3-4 first week (coincident with the educational program sessions) and the rest at home. Adaptation of targets of HbA1c and blood pressure (BP). UCG Usual care group consists in level of care usually given in Health Care system.

Official title: Randomized Clinical Trial to Evaluate the Effectiveness of a Multimodal Intervention Program in Prefrail and Frail Type 2 Diabetic Patients on Frailty and Quality of Life in Latinamerican Countries

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

713

Start Date

2022-02-14

Completion Date

2024-05-31

Last Updated

2026-08-28

Healthy Volunteers

Conditions

Frailty Syndrome Frail Elderly Syndrome Diabetes Mellitus, Type 2

Interventions

OTHER

Multimodal intervention

1. Optimal control: HbA1c between 7.6-8.5% (60-69 mmol/mol) and Blood Pressure\<150/90 mmHg 2. The physical exercise program that will be used will be the Vivifrail program (Erasmus + UE). Vivifrail includes: Strength for arms and legs, balance and gait, flexibility and resistance. The duration will be 16 weeks. (3 weeks to explain the program in the Trial site and the rest of weeks, it will be carried out at home). 3. Nutritional and educational program to increase diabetes knowledge, develop practical self-care skills for diabetes and increase the likelihood of improving glycemic control safely. The intervention aims to minimize the risk of hypoglycemia, ensure optimal nutritional status and help to maintain functional status. Seven separate sessions of 45 minutes each one twice a week for a period of 3-4 weeks in small groups. They will be moderated by a physician or diabetes educator and focused on behavioral changes and key points.

OTHER

Usual care group

The level of usual health care that a patient with diabetes receives from their local national health system

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

Locations (1)

Hospital San Ignacio_Universidad Javeriana

Bogotá, Colombia