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

Consorcio Centro de Investigación Biomédica en Red (CIBER) · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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diabetes-mellitusnatype-2
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.
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