Exercise and education may counter frailty in older diabetics
NCT ID NCT04504968
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests a multimodal program for adults aged 65 and older with type 2 diabetes who are frail or prefrail. The program combines a 16-week exercise routine, educational sessions on diabetes self-care, and adjusted blood sugar and blood pressure goals. Researchers compare this approach to usual care to see if it improves physical function and quality of life after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A multimodal program combining physical exercise (Vivifrail), nutritional and educational sessions, and adjusted blood sugar and blood pressure targets.
- What this could lead to
- If successful, this could offer a practical, non-drug approach to help frail older adults with diabetes stay stronger and maintain a better quality of life.
- What could go wrong
- The trial is early and the program is complex, so results may vary. Participants must stick to exercise and education routines, and benefits may not apply to all.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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713 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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May 2024
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital San Ignacio_Universidad Javeriana
Bogotá, 11001, Colombia
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