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Type 2 DiabetesNCT07506278

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

A study testing Vivifrail Exercise Programme Training in people with Type 2 Diabetes and Fraity Syndrome, run by National Geriatric Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 80 years
What is being tested?
Vivifrail Exercise Programme Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteVietnam
Study dates
13 Sep 2024to 30 Jan 2026
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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site
  • Phu Tho Province General Hospital

    Viet Tri, Phu Tho, 35100

Other trials in Vietnam

About this study

Official title: 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.

Read the 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.

Being tested
Vivifrail Exercise Programme Training
Keywords
Type 2 Diabetes, Fraity syndrome, Exercise intervention, Vivifrail exercise programme, Fall Risk
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vivifrail Exercise Programme TrainingBehavioural

    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

Study groups in NCT07506278
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: Vivifrail Exercise Programme Training
Control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical performance 1 - Handgrip strength

    Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.

    Measured: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)

  2. Physical performance 2 - Gait speed

    4-metre gait speed test (the shorter time the better outcome)

    Measured: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)

  3. Physical performance 3 - Short Physical Performance Battery (SPPB)

    The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)

    Measured: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)

Secondary outcomes (5)
  1. Nutritional status

    Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)

    Measured: Prior to the start of intervention,3 months and 6 months (completion of the intervention)

  2. Activities of Daily Living (ADLs)

    Katz Index of Independence in Activities of Daily Living (scores range from 0-worst to 6-best)

    Measured: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)

  3. The Mini-Cog Score

    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)

    Measured: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)

  4. 21-item Fall Risk Index questionnaire

    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)

    Measured: Prior to the start of intervention,3 months and 6 months (completion of the intervention)

  5. Instrumental Activities of Daily Living (IADLs)

    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)

    Measured: First visit, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start13 Sep 2024
  3. Primary completion28 Jul 2025
  4. Study completion30 Jan 2026

Resources

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
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07506278
Sponsor's protocol ID
Organization's Unique Protocol
Status last verified
Mar 2026
First submitted
23 Mar 2026
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Topolski TD, LoGerfo J, Patrick DL, Williams B, Walwick J, Patrick MB. The Rapid Assessment of Physical Activity (RAPA) among older adults. Prev Chronic Dis. 2006 Oct;3(4):A118. Epub 2006 Sep 15.

    PubMed 16978493
  • Buyukavci R, Akturk S, Evren B, Ersoy Y. Impacts of combined osteopenia/osteoporosis and sarcopenia on balance and quality of life in older adults. North Clin Istanb. 2020 Oct 1;7(6):585-590. doi: 10.14744/nci.2020.28003. eCollection 2020.

    PubMed 33381698
  • Zhang XL, Zhang Z, Zhu YX, Tao J, Zhang Y, Wang YY, Ke YY, Ren CX, Xu J, Zhang XY. Comparison of the efficacy of Nutritional Risk Screening 2002 and Mini Nutritional Assessment Short Form in recognizing sarcopenia and predicting its mortality. Eur J Clin Nutr. 2020 Jul;74(7):1029-1037. doi: 10.1038/s41430-020-0621-8. Epub 2020 Apr 9.

    PubMed 32273572
  • Beltz S, Gloystein S, Litschko T, Laag S, van den Berg N. Multivariate analysis of independent determinants of ADL/IADL and quality of life in the elderly. BMC Geriatr. 2022 Nov 23;22(1):894. doi: 10.1186/s12877-022-03621-3.

    PubMed 36418975
  • Nguyen TTH, Vu HTT, Nguyen TN, Dao HT, Nguyen TX, Nguyen HTT, Dang AK, Nguyen AT, Pham T, Vu GT, Tran BX, Latkin CA, Ho CS, Ho RC. Assessment of nutritional status in older diabetic outpatients and related factors in Hanoi, Vietnam. J Multidiscip Healthc. 2019 Jul 30;12:601-606. doi: 10.2147/JMDH.S194155. eCollection 2019.

    PubMed 31534342
  • Sanchez-Sanchez JL, Udina C, Medina-Rincon A, Esbri-Victor M, Bartolome-Martin I, Moral-Cuesta D, Marin-Epelde I, Ramon-Espinoza F, Latorre MS, Idoate F, Goni-Sarries A, Martinez-Martinez B, Bonet RE, Librero J, Casas-Herrero A. Effect of a multicomponent exercise program and cognitive stimulation (VIVIFRAIL-COGN) on falls in frail community older persons with high risk of falls: study protocol for a randomized multicenter control trial. BMC Geriatr. 2022 Jul 23;22(1):612. doi: 10.1186/s12877-022-03214-0.

    PubMed 35870875
  • Tamura Y, Omura T, Toyoshima K, Araki A. Nutrition Management in Older Adults with Diabetes: A Review on the Importance of Shifting Prevention Strategies from Metabolic Syndrome to Frailty. Nutrients. 2020 Nov 1;12(11):3367. doi: 10.3390/nu12113367.

    PubMed 33139628
  • Lopez-Garcia E, Hagan KA, Fung TT, Hu FB, Rodriguez-Artalejo F. Mediterranean diet and risk of frailty syndrome among women with type 2 diabetes. Am J Clin Nutr. 2018 May 1;107(5):763-771. doi: 10.1093/ajcn/nqy026.

    PubMed 29722845
  • Gobl C, Tura A. Focus on Nutritional Aspects of Sarcopenia in Diabetes: Current Evidence and Remarks for Future Research. Nutrients. 2022 Jan 13;14(2):312. doi: 10.3390/nu14020312.

    PubMed 35057493
  • O'Donovan M, Sezgin D, O'Caoimh R, Liew A. The relationship between frailty and diabetes: An investigation of self-rated health, depression symptoms and quality of life in the Study of Health Aging and Retirement in Europe. Arch Gerontol Geriatr. 2021 Sep-Oct;96:104448. doi: 10.1016/j.archger.2021.104448. Epub 2021 May 29.

    PubMed 34144317
  • Sinclair AJ, Abdelhafiz A, Dunning T, Izquierdo M, Rodriguez Manas L, Bourdel-Marchasson I, Morley JE, Munshi M, Woo J, Vellas B. An International Position Statement on the Management of Frailty in Diabetes Mellitus: Summary of Recommendations 2017. J Frailty Aging. 2018;7(1):10-20. doi: 10.14283/jfa.2017.39.

    PubMed 29412437
  • Hanlon P, Faure I, Corcoran N, Butterly E, Lewsey J, McAllister D, Mair FS. Frailty measurement, prevalence, incidence, and clinical implications in people with diabetes: a systematic review and study-level meta-analysis. Lancet Healthy Longev. 2020 Dec;1(3):e106-e116. doi: 10.1016/S2666-7568(20)30014-3.

    PubMed 33313578
  • Aguayo GA, Hulman A, Vaillant MT, Donneau AF, Schritz A, Stranges S, Malisoux L, Huiart L, Guillaume M, Sabia S, Witte DR. Prospective Association Among Diabetes Diagnosis, HbA1c, Glycemia, and Frailty Trajectories in an Elderly Population. Diabetes Care. 2019 Oct;42(10):1903-1911. doi: 10.2337/dc19-0497. Epub 2019 Aug 26.

    PubMed 31451533
  • Cheng G, Huang C, Deng H, Wang H. Diabetes as a risk factor for dementia and mild cognitive impairment: a meta-analysis of longitudinal studies. Intern Med J. 2012 May;42(5):484-91. doi: 10.1111/j.1445-5994.2012.02758.x.

    PubMed 22372522
  • Aguayo GA, Fagherazzi G. Intricate relationships between frailty and diabetes: where do we go from here? Lancet Healthy Longev. 2020 Dec;1(3):e92-e93. doi: 10.1016/S2666-7568(20)30019-2. Epub 2020 Nov 19. No abstract available.

    PubMed 36094190

Questions about this trial

What is this clinical trial studying?

A study testing Vivifrail Exercise Programme Training in people with Type 2 Diabetes and Fraity Syndrome, run by National Geriatric Hospital at 1 site in Vietnam.

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 4 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 1 Apr 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 Vietnam. 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. 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?

Physical performance 1 - Handgrip strength (time frame: Prior to the start of intervention, 3 months and 6 months (completion of the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07506278, which also lists 24 linked publications.

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 1 Apr 2026.

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