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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ngan Thi Kim Duong, Master | Phu Tho Province General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phu Tho Province General Hospital | Viet Tri | Phu Tho | 35100 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16978493 | Background | 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. | |
| 33381698 | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
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 | 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 | 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) | 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 |
| 32273572 | 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. |
| 36418975 | 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. |
| 31534342 | 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. |
| 35870875 | 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. |
| 33139628 | 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. |
| 29722845 | 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. |
| 35057493 | 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. |
| 34144317 | 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. |
| 29412437 | 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. |
| 33313578 | 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. |
| 31451533 | 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. |
| 22372522 | 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. |
| 36094190 | 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. |
| 22098178 | Background | Heuberger RA. The frailty syndrome: a comprehensive review. J Nutr Gerontol Geriatr. 2011;30(4):315-68. doi: 10.1080/21551197.2011.623931. |
| 11253156 | 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. |
| 23327448 | 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. |
| 20852673 | 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. |
| 32743307 | 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. |
| 20158543 | 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. |
| 20536960 | 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. |
| 16776798 | 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. |
| 10339630 | Background | Sinclair AJ. Diabetes in the elderly: A perspective from the United Kingdom. Clin Geriatr Med. 1999 May;15(2):225-37. |
| D004700 | Endocrine System Diseases |