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

NCT07506278 | Completed DMC

• 1 other identifier: Organization's Unique Protocol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes; Fraity Syndrome; Exercise Intervention

Keywords

Type 2 Diabetes; Fraity syndrome; Exercise intervention; Vivifrail exercise programme; Fall Risk

Outcome Measures

Primary Outcomes (3)

• Physical performance 1 - Handgrip strength

  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

  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)

  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 Outcomes (5)

• Nutritional status

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

• Activities of Daily Living (ADLs)

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

• The Mini-Cog Score

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

• 21-item Fall Risk Index questionnaire

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

• Instrumental Activities of Daily Living (IADLs)

  First visit, 3 months, 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Vivifrail Exercise Programme Training BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Geriatric Hospital: lead

Study Sites (1)

Phu Tho Province General Hospital

Việt Trì, Phu Tho, 35100, Vietnam

Location

Related Publications (24)

• 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.

  PMID: 16978493 BACKGROUND

• 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.

  PMID: 33381698 BACKGROUND

• 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.

  PMID: 32273572 BACKGROUND

• 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.

  PMID: 36418975 BACKGROUND

• 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.

  PMID: 31534342 BACKGROUND

• 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.

  PMID: 35870875 BACKGROUND

• 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.

  PMID: 33139628 BACKGROUND

• 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.

  PMID: 29722845 BACKGROUND

• 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.

  PMID: 35057493 BACKGROUND

• 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.

  PMID: 34144317 BACKGROUND

• 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.

  PMID: 29412437 BACKGROUND

• 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.

  PMID: 33313578 BACKGROUND

• 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.

  PMID: 31451533 BACKGROUND

• 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.

  PMID: 22372522 BACKGROUND

• 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.

  PMID: 36094190 BACKGROUND

• Heuberger RA. The frailty syndrome: a comprehensive review. J Nutr Gerontol Geriatr. 2011;30(4):315-68. doi: 10.1080/21551197.2011.623931.

  PMID: 22098178 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.

  PMID: 23327448 BACKGROUND

• Waters DL, Baumgartner RN, Garry PJ, Vellas B. Advantages of dietary, exercise-related, and therapeutic interventions to prevent and treat sarcopenia in adult patients: an update. Clin Interv Aging. 2010 Sep 7;5:259-70. doi: 10.2147/cia.s6920.

  PMID: 20852673 BACKGROUND

• Yoon SJ, Kim KI. Frailty and Disability in Diabetes. Ann Geriatr Med Res. 2019 Dec;23(4):165-169. doi: 10.4235/agmr.19.0036. Epub 2019 Dec 23.

  PMID: 32743307 BACKGROUND

• Andela RM, Dijkstra A, Slaets JP, Sanderman R. Prevalence of frailty on clinical wards: description and implications. Int J Nurs Pract. 2010 Feb;16(1):14-9. doi: 10.1111/j.1440-172X.2009.01807.x.

  PMID: 20158543 BACKGROUND

• Hubbard RE, Andrew MK, Fallah N, Rockwood K. Comparison of the prognostic importance of diagnosed diabetes, co-morbidity and frailty in older people. Diabet Med. 2010 May;27(5):603-6. doi: 10.1111/j.1464-5491.2010.02977.x.

  PMID: 20536960 BACKGROUND

• Walston J, Hadley EC, Ferrucci L, Guralnik JM, Newman AB, Studenski SA, Ershler WB, Harris T, Fried LP. Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. J Am Geriatr Soc. 2006 Jun;54(6):991-1001. doi: 10.1111/j.1532-5415.2006.00745.x.

  PMID: 16776798 BACKGROUND

• Sinclair AJ. Diabetes in the elderly: A perspective from the United Kingdom. Clin Geriatr Med. 1999 May;15(2):225-37.

  PMID: 10339630 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ngan Thi Kim Duong, Master

  Phu Tho Province General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 1, 2026
• Study Start: September 13, 2024
• Primary Completion: July 28, 2025
• Study Completion: January 30, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

VN (1)