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

Official title

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

Overview

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.

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.

Interventions

• Behavioral 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

Primary outcome measures

• 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)]
• Physical performance 2 - Gait speed [Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)]
• Physical performance 3 - Short Physical Performance Battery (SPPB) [Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)]
• Muscle mass [Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)]

Secondary outcome measures (3)

• Nutritional status [Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)]
• Health-related Quality of Life [Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)]
• Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) [Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)]

Eligibility criteria

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

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• National Geriatric Hospital — Hanoi

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. PMID 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 PMID 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. PMID 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( PMID 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. PMID 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. PMID 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. PMID 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. PMID 18973755

Identifiers

NCT: NCT06337357 · NatGerHos-Sarcopenia

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗