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NCT Number: NCT06337357

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

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.

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Key information

Conditions

Sarcopenia Atrophy Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Geriatric Hospital

Hanoi, 100000, Vietnam

Location status: Recruiting

Location contact

Huyen TT Vu, PhD

CONTACT

[email protected]

+84913531579

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Progressive resistance training

Behavioral

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.

Primary outcomes

  1. 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)

    Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.

  2. 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)

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

  3. 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)

    The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)

  4. Muscle mass

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

    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.

Secondary outcomes

  1. Nutritional status

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

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

  2. Health-related Quality of Life

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

    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.

  3. 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)

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anh N Trinh, MD

CONTACT

[email protected]

(+84) 912760684

Tam N Nguyen, PhD

CONTACT

[email protected]

+84979221905

Sponsors and collaborators

Lead sponsor

National Geriatric Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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