Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia
NCT ID: NCT06337357
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
80 participants
INTERVENTIONAL
2024-04-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Theory-based Home-based Multi-component Exercise Training Among Older Adults With Type 2 Diabetes Mellitus
NCT06393244
Resistance Training in Diabetic Elder Patients
NCT01638351
Effects of 12- Weeks of Quantitative Weight-bearing Progressive Resistance Exercise Training on Glycemia Control and Improving Muscle Strength With Type 2 Diabetes Combine Pre-sarcopenia.
NCT04647617
Muscle Strength Training for Older Adults With Type II Diabetes
NCT03280758
Diet and Exercise Interventions to Increase Muscle Strength and Function
NCT02850562
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
The intervention group receives supervised resistance training instructions and baseline treatment for sarcopenia and diabetes:
* Resistance training with elastic bands aims to increase muscle strength and muscle mass of the upper and lower limbs. Training duration 12 weeks, frequency 2 times/week, intensity gradually increases.
* Baseline treatment for diabetes and sarcopenia: Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients and baseline treatment for sarcopenia (education about sarcopenia and treatment measures such as diet and exercise) and provide basic information on resistance training.
Progressive Resistance Training
Progressive resistance training includes face-to-face education on resistance training:
Resistance exercises with elastic bands include 9 exercises for 1 course. During the first 4 weeks, the patient exercises twice a week with a level of exertion according to Borg's category-ratio 10 (CR10) scale of 4-5 points. For the next 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 6-7 points. In the last 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 8-9 points.
The three-month intervention involves twelve 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-visited by investigators in the hospital.
Control group
The control group receives the baseline treatment for diabetes and sarcopenia:
\- Recommendations according to American Diabetes Association guidelines which include instructions to follow the diet and exercises as recommended for older type 2 diabetic patients and baseline treatment for sarcopenia (education about sarcopenia and treatment measures such as diet and exercise) and provide basic information on resistance training.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Progressive Resistance Training
Progressive resistance training includes face-to-face education on resistance training:
Resistance exercises with elastic bands include 9 exercises for 1 course. During the first 4 weeks, the patient exercises twice a week with a level of exertion according to Borg's category-ratio 10 (CR10) scale of 4-5 points. For the next 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 6-7 points. In the last 4 weeks, the patient exercises twice a week with Borg's CR10 exertion level of 8-9 points.
The three-month intervention involves twelve 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-visited by investigators in the hospital.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c ≥ 7.0 and ≤ 8.5%
* Sarcopenia diagnosed using criteria from the Asian Working Group for Sarcopenia 2019
* Age ≥ 60 and ≤ 80
Exclusion Criteria
* 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.
* Patients with cardiovascular diseases: chest pain, uncontrolled blood pressure ≥160/100 mmHg, untreated cardiac arrhythmia, a history of congestive heart failure, severe valvular heart disease, myocarditis or pericarditis, and hypertrophic cardiomyopathy.
* Renal failure with estimated glomerular function rate (Modification of Diet in Renal Disease equation) \< 60 ml/min/m3 or serum creatinine ≥ 130 µmol/l
* On treatment with Sodium-glucose cotransporter 2 inhibitors (SGLT2i)
60 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Geriatric Hospital
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Trinh Ngoc Anh
Endocrinologist, Principal Investigator and Sponsor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Huyen TT Vu, PhD
Role: STUDY_CHAIR
National Geriatric Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Geriatric Hospital
Hanoi, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Mesinovic J, Zengin A, De Courten B, Ebeling PR, Scott D. Sarcopenia and type 2 diabetes mellitus: a bidirectional relationship. Diabetes Metab Syndr Obes. 2019 Jul 8;12:1057-1072. doi: 10.2147/DMSO.S186600. eCollection 2019.
Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
Kerner W, Bruckel J; German Diabetes Association. Definition, classification and diagnosis of diabetes mellitus. Exp Clin Endocrinol Diabetes. 2014 Jul;122(7):384-6. doi: 10.1055/s-0034-1366278. Epub 2014 Jul 11. No abstract available.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Chen LK. The vicious cycle in the development of diabetes mellitus and sarcopenia in older persons. Arch Gerontol Geriatr. 2021 Jul-Aug;95:104437. doi: 10.1016/j.archger.2021.104437. Epub 2021 May 19. No abstract available.
Purnamasari D, Tetrasiwi EN, Kartiko GJ, Astrella C, Husam K, Laksmi PW. Sarcopenia and Chronic Complications of Type 2 Diabetes Mellitus. Rev Diabet Stud. 2022 Sep 28;18(3):157-165. doi: 10.1900/RDS.2022.18.157.
Chomentowski P, Coen PM, Radikova Z, Goodpaster BH, Toledo FG. Skeletal muscle mitochondria in insulin resistance: differences in intermyofibrillar versus subsarcolemmal subpopulations and relationship to metabolic flexibility. J Clin Endocrinol Metab. 2011 Feb;96(2):494-503. doi: 10.1210/jc.2010-0822. Epub 2010 Nov 24.
Russell ST, Rajani S, Dhadda RS, Tisdale MJ. Mechanism of induction of muscle protein loss by hyperglycaemia. Exp Cell Res. 2009 Jan 1;315(1):16-25. doi: 10.1016/j.yexcr.2008.10.002. Epub 2008 Oct 17.
Roubenoff R, Parise H, Payette HA, Abad LW, D'Agostino R, Jacques PF, Wilson PW, Dinarello CA, Harris TB. Cytokines, insulin-like growth factor 1, sarcopenia, and mortality in very old community-dwelling men and women: the Framingham Heart Study. Am J Med. 2003 Oct 15;115(6):429-35. doi: 10.1016/j.amjmed.2003.05.001.
Phillips T, Leeuwenburgh C. Muscle fiber specific apoptosis and TNF-alpha signaling in sarcopenia are attenuated by life-long calorie restriction. FASEB J. 2005 Apr;19(6):668-70. doi: 10.1096/fj.04-2870fje. Epub 2005 Jan 21.
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.
Kumar P, Umakanth S, Girish N. A review of the components of exercise prescription for sarcopenic older adults. Eur Geriatr Med. 2022 Dec;13(6):1245-1280. doi: 10.1007/s41999-022-00693-7. Epub 2022 Sep 2.
Hurst C, Robinson SM, Witham MD, Dodds RM, Granic A, Buckland C, De Biase S, Finnegan S, Rochester L, Skelton DA, Sayer AA. Resistance exercise as a treatment for sarcopenia: prescription and delivery. Age Ageing. 2022 Feb 2;51(2):afac003. doi: 10.1093/ageing/afac003.
Ai Y, Xu R, Liu L. The prevalence and risk factors of sarcopenia in patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Diabetol Metab Syndr. 2021 Sep 3;13(1):93. doi: 10.1186/s13098-021-00707-7.
Sanz-Canovas J, Lopez-Sampalo A, Cobos-Palacios L, Ricci M, Hernandez-Negrin H, Mancebo-Sevilla JJ, Alvarez-Recio E, Lopez-Carmona MD, Perez-Belmonte LM, Gomez-Huelgas R, Bernal-Lopez MR. Management of Type 2 Diabetes Mellitus in Elderly Patients with Frailty and/or Sarcopenia. Int J Environ Res Public Health. 2022 Jul 16;19(14):8677. doi: 10.3390/ijerph19148677.
Che S, Meng M, Jiang Y, Ye X, Xie C. Perceptions of exercise and exercise instruction in patients with type 2 diabetes mellitus and sarcopenia : a qualitative study. BMC Geriatr. 2022 Nov 22;22(1):892. doi: 10.1186/s12877-022-03519-0.
Studenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010.
Izzo A, Massimino E, Riccardi G, Della Pepa G. A Narrative Review on Sarcopenia in Type 2 Diabetes Mellitus: Prevalence and Associated Factors. Nutrients. 2021 Jan 9;13(1):183. doi: 10.3390/nu13010183.
Dai S, Shu D, Meng F, Chen Y, Wang J, Liu X, Xiao X, Guo W, Chen F. Higher Risk of Sarcopenia in Older Adults with Type 2 Diabetes: NHANES 1999-2018. Obes Facts. 2023;16(3):237-248. doi: 10.1159/000530241. Epub 2023 Apr 3.
Sugimoto K, Tabara Y, Ikegami H, Takata Y, Kamide K, Ikezoe T, Kiyoshige E, Makutani Y, Onuma H, Gondo Y, Ikebe K, Ichihashi N, Tsuboyama T, Matsuda F, Kohara K, Kabayama M, Fukuda M, Katsuya T, Osawa H, Hiromine Y, Rakugi H. Hyperglycemia in non-obese patients with type 2 diabetes is associated with low muscle mass: The Multicenter Study for Clarifying Evidence for Sarcopenia in Patients with Diabetes Mellitus. J Diabetes Investig. 2019 Nov;10(6):1471-1479. doi: 10.1111/jdi.13070. Epub 2019 Jun 1.
Chung SM, Moon JS, Chang MC. Prevalence of Sarcopenia and Its Association With Diabetes: A Meta-Analysis of Community-Dwelling Asian Population. Front Med (Lausanne). 2021 May 20;8:681232. doi: 10.3389/fmed.2021.681232. eCollection 2021.
Hong S, Chang Y, Jung HS, Yun KE, Shin H, Ryu S. Relative muscle mass and the risk of incident type 2 diabetes: A cohort study. PLoS One. 2017 Nov 30;12(11):e0188650. doi: 10.1371/journal.pone.0188650. eCollection 2017.
Wu H, Liu M, Chi VTQ, Wang J, Zhang Q, Liu L, Meng G, Yao Z, Bao X, Gu Y, Zhang S, Sun S, Zhou M, Jia Q, Song K, Huang J, Huo J, Zhang B, Ding G, Niu K. Handgrip strength is inversely associated with metabolic syndrome and its separate components in middle aged and older adults: a large-scale population-based study. Metabolism. 2019 Apr;93:61-67. doi: 10.1016/j.metabol.2019.01.011. Epub 2019 Jan 25.
Lee CG, Boyko EJ, Strotmeyer ES, Lewis CE, Cawthon PM, Hoffman AR, Everson-Rose SA, Barrett-Connor E, Orwoll ES; Osteoporotic Fractures in Men Study Research Group. Association between insulin resistance and lean mass loss and fat mass gain in older men without diabetes mellitus. J Am Geriatr Soc. 2011 Jul;59(7):1217-24. doi: 10.1111/j.1532-5415.2011.03472.x. Epub 2011 Jun 30.
Yang Q, Zhang Y, Zeng Q, Yang C, Shi J, Zhang C, Ni X, Du Z, Tang Z, Hu J, Li X, Cai J, Li Q, Cheng Q. Correlation Between Diabetic Peripheral Neuropathy and Sarcopenia in Patients with Type 2 Diabetes Mellitus and Diabetic Foot Disease: A Cross-Sectional Study. Diabetes Metab Syndr Obes. 2020 Feb 13;13:377-386. doi: 10.2147/DMSO.S237362. eCollection 2020.
Solerte SB, Gazzaruso C, Bonacasa R, Rondanelli M, Zamboni M, Basso C, Locatelli E, Schifino N, Giustina A, Fioravanti M. Nutritional supplements with oral amino acid mixtures increases whole-body lean mass and insulin sensitivity in elderly subjects with sarcopenia. Am J Cardiol. 2008 Jun 2;101(11A):69E-77E. doi: 10.1016/j.amjcard.2008.03.004.
Naseeb MA, Volpe SL. Protein and exercise in the prevention of sarcopenia and aging. Nutr Res. 2017 Apr;40:1-20. doi: 10.1016/j.nutres.2017.01.001. Epub 2017 Jan 16.
Martinez-Arnau FM, Fonfria-Vivas R, Cauli O. Beneficial Effects of Leucine Supplementation on Criteria for Sarcopenia: A Systematic Review. Nutrients. 2019 Oct 17;11(10):2504. doi: 10.3390/nu11102504.
Uchitomi R, Oyabu M, Kamei Y. Vitamin D and Sarcopenia: Potential of Vitamin D Supplementation in Sarcopenia Prevention and Treatment. Nutrients. 2020 Oct 19;12(10):3189. doi: 10.3390/nu12103189.
Beaudart C, Buckinx F, Rabenda V, Gillain S, Cavalier E, Slomian J, Petermans J, Reginster JY, Bruyere O. The effects of vitamin D on skeletal muscle strength, muscle mass, and muscle power: a systematic review and meta-analysis of randomized controlled trials. J Clin Endocrinol Metab. 2014 Nov;99(11):4336-45. doi: 10.1210/jc.2014-1742. Epub 2014 Jul 17.
Antoniak AE, Greig CA. The effect of combined resistance exercise training and vitamin D3 supplementation on musculoskeletal health and function in older adults: a systematic review and meta-analysis. BMJ Open. 2017 Jul 20;7(7):e014619. doi: 10.1136/bmjopen-2016-014619.
Gkekas NK, Anagnostis P, Paraschou V, Stamiris D, Dellis S, Kenanidis E, Potoupnis M, Tsiridis E, Goulis DG. The effect of vitamin D plus protein supplementation on sarcopenia: A systematic review and meta-analysis of randomized controlled trials. Maturitas. 2021 Mar;145:56-63. doi: 10.1016/j.maturitas.2021.01.002. Epub 2021 Jan 12.
Ganapathy A, Nieves JW. Nutrition and Sarcopenia-What Do We Know? Nutrients. 2020 Jun 11;12(6):1755. doi: 10.3390/nu12061755.
Krzyminska-Siemaszko R, Czepulis N, Lewandowicz M, Zasadzka E, Suwalska A, Witowski J, Wieczorowska-Tobis K. The Effect of a 12-Week Omega-3 Supplementation on Body Composition, Muscle Strength and Physical Performance in Elderly Individuals with Decreased Muscle Mass. Int J Environ Res Public Health. 2015 Aug 28;12(9):10558-74. doi: 10.3390/ijerph120910558.
Holten MK, Zacho M, Gaster M, Juel C, Wojtaszewski JF, Dela F. Strength training increases insulin-mediated glucose uptake, GLUT4 content, and insulin signaling in skeletal muscle in patients with type 2 diabetes. Diabetes. 2004 Feb;53(2):294-305. doi: 10.2337/diabetes.53.2.294.
Hovanec N, Sawant A, Overend TJ, Petrella RJ, Vandervoort AA. Resistance training and older adults with type 2 diabetes mellitus: strength of the evidence. J Aging Res. 2012;2012:284635. doi: 10.1155/2012/284635. Epub 2012 Sep 4.
Lee J, Kim D, Kim C. Resistance Training for Glycemic Control, Muscular Strength, and Lean Body Mass in Old Type 2 Diabetic Patients: A Meta-Analysis. Diabetes Ther. 2017 Jun;8(3):459-473. doi: 10.1007/s13300-017-0258-3. Epub 2017 Apr 5.
Zhang Y, Zou L, Chen ST, Bae JH, Kim DY, Liu X, Song W. Effects and Moderators of Exercise on Sarcopenic Components in Sarcopenic Elderly: A Systematic Review and Meta-Analysis. Front Med (Lausanne). 2021 May 19;8:649748. doi: 10.3389/fmed.2021.649748. eCollection 2021.
Yee XS, Ng YS, Allen JC, Latib A, Tay EL, Abu Bakar HM, Ho CYJ, Koh WCC, Kwek HHT, Tay L. Performance on sit-to-stand tests in relation to measures of functional fitness and sarcopenia diagnosis in community-dwelling older adults. Eur Rev Aging Phys Act. 2021 Jan 8;18(1):1. doi: 10.1186/s11556-020-00255-5.
Katula JA, Rejeski WJ, Marsh AP. Enhancing quality of life in older adults: a comparison of muscular strength and power training. Health Qual Life Outcomes. 2008 Jun 13;6:45. doi: 10.1186/1477-7525-6-45.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NatGerHos-Sarcopenia
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.