Frailty SyndromeDIABFRAILNCT04504968
Effectiveness of a Multimodal Intervention on Function in Older Frail People With Diabetes in Latinamerican
A study testing Multimodal intervention in people with Frailty Syndrome and Frail Elderly Syndrome, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome, Frail Elderly Syndrome, Diabetes Mellitus, Type 2
- What is being tested?
- Multimodal intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 713 participants
- Where
- 1 siteColombia
- Study dates
- 14 Feb 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the detailed description
International, multicentre, single-blind, two parallel groups, pragmatic randomised Research Clinical Trial. 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 5-7 trial sites that will recruit 51 participants (255 participants per country) except Mexico which will select 2 sites to recruit 50 participants each one (100 participants).
There will be a National lead investigator in each involved country. This National lead investigator will be trained by the general coordinator team in the procedures of the study. Each National lead investigator will be responsible for the training in his/her country. In each country, the lead will select the recruitment trial sites (5-7 in each country) and each trial site will recruit 51 participants approximately except in Mexico (see above). All data will be collected in an eCRF (electronic case report form) platform designed specifically for this project.
This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status.
Objectives:
Main objective: To assess the effectiveness of a multi-modal intervention in subjects with type 2 Diabetes Mellitus aged ≥ 65 years who are frail or pre-frail in terms of function and quality of life in comparison with usual clinical practice.
Secondary objectives:
- Changes in the frailty status (trajectories of frailty: frail to prefrail; frail to robustness; prefrail to robustness and vice versa).
- Incidence rate of symptomatic hypoglycemia and hypoglycemic coma.
- Incidence rate of hospital admission.
- Incidence rate of permanent institutionalization.
- Carer burden.
- Laboratory biomarkers of prognostic value for response to treatment
Usual care group:
Usual clinical practice is the level of usual health care that a patient with diabetes receives from their local national health system.
Intervention group:
- Optimal glycosylated hemoglobin range between 7.6-8.5% (60-69 mmol/mol) and optimal blood pressure: <150/90 mmHg
- Physical exercise program that will be used will be the Vivifrail program, developed in Europe (Erasmus + UE). Vivifrail includes:
- Strength exercises for arms and legs.
- Balance and gait, to avoid falls.
- Flexibility.
- Resistance. The duration of the training program will be 16 weeks.
- Nutritional and educational program: The intervention is designed 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 maintain functional status.
- Being tested
- Multimodal intervention, Usual care group
- Medical subject headings
- Frailty, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal interventionOther
- Optimal control: HbA1c between 7.6-8.5% (60-69 mmol/mol) and Blood Pressure<150/90 mmHg
- 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).
- 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.
Usual care groupOther
The level of usual health care that a patient with diabetes receives from their local national health system
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Multimodal intervention: Receives: Other: Multimodal intervention |
| Usual care group | Placebo comparator | Usual care group Receives: Other: Usual care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in physical function
(SPPB scale)The primary outcome is the difference in function after 12 months of follow-up between the intervention group and usual clinical practice measured by changes in the Short Physical Performance Battery (SPPB) scale. SPPB scores between 0-12. 0 is the worse and 12 the best value.
Measured: 1 year
Secondary outcomes (13)
Frailty trajectories
Trajectories of frailty according to changes in Fried´s phenotype. Frieds Phenotype scores between 0 and 5. 0 means robust; 1-2 mean prefrail and 3 or more mean frail
Measured: 1 year
Frailty trajectories
Trajectories of frailty according to changes frail trait scale (FTS). FTS scores between 0-50. 0 is the best value and 50 the worst value.
Measured: 1 year
Frailty trajectories
Trajectories of frailty according to changes in FRAIL scale. FRAIL scores SPPB scores between 0-5. 0 means robust; 1-2 mean prefrail and 3 or more mean frail
Measured: 1 year
Basic activities of daily living
Deterioration of basic activities of daily living (BADL) according to changes in at least 10 points of Barthel index. Barthel scores between 0-100; 0 is the worst value and 100 the best.
Measured: 1 year
Instrumental activities of daily living
Deterioration of instrumental activities of daily living (IADL) according to changes in at least 1 point of Lawton scale. Lawton scale scores between 0-10; 0 is the worst and 10 the best value
Measured: 1 year
Rate of Hypoglycemia
Episodes of symptomatic hypoglycemia (proven glycaemia below 4mmol/L, or signs and symptoms attributed to hypoglycemia that respond to specific treatment) and hypoglycemic coma
Measured: 1 year
Number of Hospital admission
Episodes of hospital admission (any overnight admission)
Measured: 1 year
Number of patients with Permanent institutionalization
Permanent Institutionalization yeas or not
Measured: 1 year
Rate of Falls
Number of falls
Measured: 1 year
Rate of Severe Falls
Number of severe falls (2 or more falls in the year or at least 1 fall that requires medical assistance)
Measured: 1 year
Caregiver burden
Caregiver burden (if exist) evaluated by the Zarit scale (ZBI). The ZBI consists of 22 items rated that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88.9 Higher scores indicate greater burden.
Measured: 1 year
Rate of mortality
Number of patients who died
Measured: 1 year
Health-related quality of life
Changes in Participant Health-related quality of life evaluated by EuroQoL 5D 3L(European Quality of life). EuroQoL scores between 0-10 and 10 is the worse quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start14 Feb 2022
- Primary completion30 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- he DIABFRAIL-LATAM is an open randomized clinical trial, with random allocation 1:1 by participants to Usual Care Group (UCG) or Intervention Group (IG)
- Masking
- None (open label)
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
- Sponsor type
- Other government
- Collaborators
- Pan American Health Organization, Catholic University of the Sacred Heart, Diabetes Frail Ltd, University of Castilla-La Mancha, Confederación Española de Organizaciones de Mayores (CEOMA), Pontificia Universidad Javeriana, Pontificia Universidad Catolica de Chile, Instituto Nacional de Geriatria, Mexico, Universidad de San Martín de Porres (USMP), Universidad de Santiago de Chile
- Responsible party
- Sponsor
- Investigators
- LEOCADIO RODRIGUEZ-MAÑAS, PhD, Principal investigator, Consorcio Centro de Investigación Biomédica en Red (CIBER)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504968
- Sponsor's protocol ID
- DIABFRAIL-LATAM
- Acronym
- DIABFRAIL
- Status last verified
- Aug 2023
- First submitted
- 5 May 2020
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04504968
- Acronym / sponsor ID
- DIABFRAIL / DIABFRAIL-LATAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)Other government
- Collaborators
- Pan American Health Organization, Catholic University of the Sacred Heart, Diabetes Frail Ltd, University of Castilla-La Mancha, Confederación Española de Organizaciones de Mayores (CEOMA), Pontificia Universidad Javeriana, Pontificia Universidad Catolica de Chile, Instituto Nacional de Geriatria, Mexico, Universidad de San Martín de Porres (USMP), Universidad de Santiago de Chile
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
International, multicentre, single-blind, two parallel groups, pragmatic randomised Research Clinical Trial. 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 5-7 trial sites that will recruit 51 participants (255 participants per country) except Mexico which will select 2 sites to recruit 50 participants each one (100 participants).
There will be a National lead investigator in each involved country. This National lead investigator will be trained by the general coordinator team in the procedures of the study. Each National lead investigator will be responsible for the training in his/her country. In each country, the lead will select the recruitment trial sites (5-7 in each country) and each trial site will recruit 51 participants approximately except in Mexico (see above). All data will be collected in an eCRF (electronic case report form) platform designed specifically for this project.
This study is focused on an older population (≥ 65 years) with diabetes and a frail or prefrail status.
Objectives:
Main objective: To assess the effectiveness of a multi-modal intervention in subjects with type 2 Diabetes Mellitus aged ≥ 65 years who are frail or pre-frail in terms of function and quality of life in comparison with usual clinical practice.
Secondary objectives:
- Changes in the frailty status (trajectories of frailty: frail to prefrail; frail to robustness; prefrail to robustness and vice versa).
- Incidence rate of symptomatic hypoglycemia and hypoglycemic coma.
- Incidence rate of hospital admission.
- Incidence rate of permanent institutionalization.
- Carer burden.
- Laboratory biomarkers of prognostic value for response to treatment
Usual care group:
Usual clinical practice is the level of usual health care that a patient with diabetes receives from their local national health system.
Intervention group:
- Optimal glycosylated hemoglobin range between 7.6-8.5% (60-69 mmol/mol) and optimal blood pressure: <150/90 mmHg
- Physical exercise program that will be used will be the Vivifrail program, developed in Europe (Erasmus + UE). Vivifrail includes:
- Strength exercises for arms and legs.
- Balance and gait, to avoid falls.
- Flexibility.
- Resistance. The duration of the training program will be 16 weeks.
- Nutritional and educational program: The intervention is designed 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 maintain functional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- he DIABFRAIL-LATAM is an open randomized clinical trial, with random allocation 1:1 by participants to Usual Care Group (UCG) or Intervention Group (IG)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Multimodal interventionMultimodal intervention: |
| Usual care group | Placebo comparator | Other: Usual care groupUsual care group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal intervention1. 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 | Intervention group |
| Usual care groupThe level of usual health care that a patient with diabetes receives from their local national health system | Other | Usual care group |
Primary outcome
Difference in physical function
Time frame: 1 year
(SPPB scale)The primary outcome is the difference in function after 12 months of follow-up between the intervention group and usual clinical practice measured by changes in the Short Physical Performance Battery (SPPB) scale. SPPB scores between 0-12. 0 is the worse and 12 the best value.
13 secondary outcomes
Frailty trajectories
Time frame: 1 year
Frailty trajectories
Time frame: 1 year
Frailty trajectories
Time frame: 1 year
Basic activities of daily living
Time frame: 1 year
Instrumental activities of daily living
Time frame: 1 year
Rate of Hypoglycemia
Time frame: 1 year
Number of Hospital admission
Time frame: 1 year
Number of patients with Permanent institutionalization
Time frame: 1 year
Rate of Falls
Time frame: 1 year
Rate of Severe Falls
Time frame: 1 year
Caregiver burden
Time frame: 1 year
Rate of mortality
Time frame: 1 year
Health-related quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEOCADIO RODRIGUEZ-MAÑAS, PhD principal investigator
Consorcio Centro de Investigación Biomédica en Red (CIBER)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention in people with Frailty Syndrome and Frail Elderly Syndrome, run by Consorcio Centro de Investigación Biomédica en Red (CIBER) at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in physical function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.