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RecruitingNCT06337357Updated May 22, 2025

Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia

An interventional study of Progressive Resistance Training in Sarcopenia and Diabetes, sponsored by National Geriatric Hospital. Recruiting at 1 site in Vietnam. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by National Geriatric Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks.

Read the detailed description

Sarcopenia, prevalent among geriatric populations, involves the progressive loss of muscle mass and decline in muscular function. This age-related condition is associated with higher susceptibility to falls, comorbidities, and mortality. Resistance training emerges as a non-pharmacological intervention proven to alleviate and potentially delay the progression of sarcopenia. However, there are still few studies investigating its effects on outcomes in older patients with diabetes mellitus.

02

Conditions studied

  • Sarcopenia
  • Diabetes

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Keywords

  • Sarcopenia
  • Diabetes
  • Resistance training
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

National Geriatric Hospital is the lead sponsor of 6 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetic patients diagnosed using American Diabetes Association 2022 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

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.
  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Progressive Resistance Training

  • No intervention
    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.

Interventions

  • BehavioralProgressive 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.

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What researchers measure

Primary outcomes

  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.

    Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)

  2. Physical performance 2 - Gait speed

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

    Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (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)

    Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)

  4. Muscle mass

    Upper and lower muscle mass are measured by Bioelectrical impedance analysis (BIA) method, using a machine model named InBody 770: the higher number the better outcome.

    Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)

Secondary outcomes

  1. Nutritional status

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

    Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)

  2. Health-related Quality of Life

    Health-related Quality of Life is assessed using the health questionnaire 5-level 5 dimensions from EuroQol Group: index scores range from -0.59 to 1; 1 is the best possible health state.

    Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)

  3. Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs)

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

    Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)

07

Study locations

1 of 1 sites recruiting
  • National Geriatric Hospital
    Hanoi, 100000, Vietnam
    Recruiting
08

References and documents

Publications

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  • 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. PubMed 24737557 ↗
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  • 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. PubMed 37011596 ↗
  • 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. PubMed 31074209 ↗
  • 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. PubMed 34095184 ↗
  • 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. PubMed 29190709 ↗
  • 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. PubMed 30690038 ↗
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  • 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. PubMed 32104034 ↗
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  • 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. PubMed 28473056 ↗
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  • 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. PubMed 34095166 ↗
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Study documents

  • Informed consent form · Jan 23, 2024

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06337357
Lead sponsor
National Geriatric Hospital
Responsible party
Trinh Ngoc Anh (Endocrinologist, Principal Investigator and Sponsor, National Geriatric Hospital) — Principal investigator
First posted
Mar 29, 2024
Start date
Apr 1, 2024
Primary completion
Sep 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 22, 2025

Study contacts

Anh N Trinh, MD
Contact
drtrinhanh.endo@gmail.com
(+84) 912760684
Tam N Nguyen, PhD
Contact
ngoctam@hmu.edu.vn
+84979221905
Huyen TT Vu, PhD
study chair · National Geriatric Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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