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SarcopeniaNCT06337357

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

A study testing Progressive Resistance Training in people with Sarcopenia and Diabetes, run by National Geriatric Hospital at 1 site in Vietnam.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Sarcopenia, Diabetes
What is being tested?
Progressive Resistance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteVietnam
Study dates
1 Apr 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 ≥ 7.0 and ≤ 8.5%
  • Sarcopenia diagnosed using criteria from the Asian Working Group for Sarcopenia 2019
  • 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.
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tam N Nguyen, PhD contact

+84979221905

ngoctam@hmu.edu.vn

Vietnam1 site, 1 recruiting
  • National Geriatric Hospital

    Hanoi, 100000

    Huyen TT Vu, PhD, +84913531579, vuthanhhuyen11@yahoo.com

    Recruiting

Other trials in Vietnam

About this study

Official title: Evaluating Resistance Training for Sarcopenia in Older Patients With Type 2 Diabetes: Treatment Outcomes

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.

Conditions
Sarcopenia, Diabetes
Being tested
Progressive Resistance Training
Keywords
Sarcopenia, Diabetes, Resistance training
Medical subject headings
Sarcopenia, Diabetes Mellitus

What participants receive

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

  • Progressive Resistance TrainingBehavioural

    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.

Study groups in NCT06337357
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: Progressive Resistance Training
Control groupNo interventionThe 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.

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, 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)

    Measured: 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)

    Measured: 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.

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

Secondary outcomes (3)
  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 (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.

    Measured: 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)

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

Timeline

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

  1. First posted29 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06337357
Sponsor's protocol ID
NatGerHos-Sarcopenia
Status last verified
May 2025
First submitted
13 Mar 2024
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31372016
  • 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.

    PubMed 32033882
  • 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.

    PubMed 25014088
  • 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.

    PubMed 30312372
  • 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.

    PubMed 34029928
  • 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.

    PubMed 36309772
  • 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.

    PubMed 21106709
  • 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.

    PubMed 18973755
  • 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.

    PubMed 14563498
  • 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.

    PubMed 15665035
  • 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
  • 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.

    PubMed 36050581
  • 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.

    PubMed 35150587
  • 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.

    PubMed 34479652
  • 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.

    PubMed 35886528

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Resistance Training in people with Sarcopenia and Diabetes, 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 7 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anh N Trinh, MD ((+84) 912760684, drtrinhanh.endo@gmail.com), or a site near the patient. 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, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)). The study lists 4 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 NCT06337357, which also lists 40 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 22 May 2025.

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