Results Of Vivifrail Exercise In Older Type 2 Diabetic Patients With Fraity Syndrome

March 27, 2026 updated by: National Geriatric Hospital

Evaluating The Effect Of Fraity Intervention In Older Adults With Typ 2 Diabetes Using Exercise

A randomized controlled clinical trial that will test how physical exercise will impact outcomes of functional ability, cognitive function and quality of life in older patients with type 2 diabetes who have been diagnosed as Fraity syndrome. The intervention will be 6 months in duration with approximately 72 sessions of exercises. Outcome measures will be collected at baseline, 3 months and 6 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fraity syndrome, prevalent among geriatric populations, is associated with higher susceptibility to falls, comorbidities, and mortality. Multidomain interventions have been shown to be effective in improving quality of life and delaying progression of functional impairment or disability in older adults. Specially, VIVIFRAIL was developed by world experts in the field of physical exercise and frailty, and is considered an important step towards the novel era of precise prescription of physical activity. Nevertheless, the effect of physical exercise as a systematic, structured and repetitive type of physical activity, in the reduction of risk of cognitive decline in the elderly, is not very clear.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Phu Tho
      • Việt Trì, Phu Tho, Vietnam, 35100
        • Phu Tho Province General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetic patients diagnosed using American Diabetes Association 2022 criteria
  • HbA1c ≥ 6.5 and ≤ 9.0%
  • Frailty diagnosed using criteria from the The Fried frailty phenotype (FP)
  • Age ≥ 60 and ≤ 80

Exclusion Criteria:

  • Acute diabetic complications
  • Patients are in the acute phase of musculoskeletal disorders: acute gout, progressing low-grade arthritis, acute joint pain due to joint degeneration, sciatic pain, and infectious arthritis.
  • Patients suffer from conditions significantly affecting cognition and mobility: sequelae of stroke (with weakness, limb paralysis), muscular weakness, limb disabilities, severe heart failure, severe cognitive decline, and psychiatric disorders.
  • Patients have been bedridden due to illness for more than 1 month within the past 3 months up to the recruitment time.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

The intervention group receives supervised Vivifrail exercise programme training instructions:

- Vivifrail exercise programme aims to increase muscle strength of the upper and lower limbs. Training duration 6 months, frequency 3 times/week, intensity gradually increases.
Behavioral: Vivifrail Exercise Programme Training

Vivifrail exercise programme includes face-to-face education on Multi-component Physical training:

A Program for patients with moderate limitation with EXERCISE WHEEL include 7 exercises for 1 course. During the first 8 weeks, the patient exercises 3 times/week with a level of exertion according to Borg's category-ratio 10 (CR10) scale of 4-5 points. For the next 8 weeks, the patient exercises 3 times/week with Borg's CR10 exertion level of 6-7 points. In the last 8 weeks, the patient exercises 3 times/week with Borg's CR10 exertion level of 8-9 points.

The six-month intervention involves twenty-four weekly calls, with a focus on building rapport (e.g. providing feedback on the baseline assessment); education reinforcement on resistance training; and skill-building (e.g. self-monitoring and resistance training diary). The emphasis is on helping participants to gain the knowledge and skills necessary to achieve targeted intensity. Every 4 weeks, all patients are re-visite
No Intervention: Control group

The control group receives the baseline treatment for diabetes:

- Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients (education about treatment measures such as diet and exercise) and provide basic information on flexibility training and balance training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance 1 - Handgrip strength
Time Frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.
Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Physical performance 2 - Gait speed
Time Frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
4-metre gait speed test (the shorter time the better outcome)
Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Physical performance 3 - Short Physical Performance Battery (SPPB)
Time Frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)
Prior to the start of intervention, 3 months and 6 months (completion of the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: Prior to the start of intervention,3 months and 6 months (completion of the intervention)
Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)
Prior to the start of intervention,3 months and 6 months (completion of the intervention)
Activities of Daily Living (ADLs)
Time Frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best)
Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
The Mini-Cog Score
Time Frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
The Mini-Cog Score uses a three-item recall for memory and intuitive clock-drawing test to screen a dementia (scores range from 0-worst to 5-best)
Prior to the start of intervention, 3 months and 6 months (completion of the intervention)
21-item Fall Risk Index questionnaire
Time Frame: Prior to the start of intervention,3 months and 6 months (completion of the intervention)
The 21-item Fall Risk Index (FRI-21) has been used to detect elderly persons at risk for falls: scores ranging from 0 (best) to 21 (worst)
Prior to the start of intervention,3 months and 6 months (completion of the intervention)
Instrumental Activities of Daily Living (IADLs)
Time Frame: First visit, 3 months, 6 months
Lawton Instrumental Activities of Daily Living Scale (scores range from 0-low function & dependent to 8-high function & independent for women, and 0-worst to 5-best for men)
First visit, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Geriatric Hospital

Investigators

  • Study Director: Ngan Thi Kim Duong, Master, Phu Tho Province General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2024

Primary Completion (Actual)

July 28, 2025

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Organization's Unique Protocol (Other Identifier: 930/2024)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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