NCT04504968Completed
Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican
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
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 713 (actual)
- First submitted
- 5 May 2020
- Start date
- 14 Feb 2022
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Diseases
- Type 2 diabetes
- NCT number
- NCT04504968
What you commit to
- Study type: Interventional
- Participants enrolled: 713
- From 14 Feb 2022 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current participation in a structured physical activity (PA) program, physical therapy or cardiopulmonary rehabilitation
Other illness
- 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)
- 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
- Acute thromboembolism
- Acute or severe heart failure
- Acute or severe respiratory failure
- Uncontrolled acute decompensated diabetes mellitus or low blood sugar
Other
- 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
- Barthel ADL score lower than 60 points
- Inability to carry out the SPPB test (total score = 0)
- Upper and/or lower extremity amputation
- Current enrolment in another randomized clinical trial (RCT) involving lifestyle, nutrition, or pharmaceutical interventions
- Aortic dissecting aneurysm
- Severe aortic stenosis
- Acute endocarditis / pericarditis
- Uncontrolled high blood pressure (\> 180/100 mmHg)
- Uncontrolled postural hypotension
- A recent fracture in the last month Any other circumstance the investigator believes to prevent undertaking physical activity
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital San Ignacio_Universidad Javeriana Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.