Exercise and education may counter frailty in older diabetics

NCT ID NCT04504968

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

713 people

The number who actually took part.

Started

Feb 2022

Finished

May 2024

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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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