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

National Geriatric Hospital

Status: Enrolling

Conditions: Diabetes; Sarcopenia

Treatments: Behavioral: Progressive Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06337357

NatGerHos-Sarcopenia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Progressive Resistance Training

Control group

No Intervention group

Description:

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.