Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia
- Conditions
- DiabetesSarcopenia
- Interventions
- Behavioral: Progressive Resistance Training
- Registration Number
- NCT06337357
- Lead Sponsor
- National Geriatric Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Progressive Resistance Training 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.
- Primary Outcome Measures
Name Time Method Muscle mass 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.
Physical performance 1 - Handgrip strength 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.
Physical performance 2 - Gait speed 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)
Physical performance 3 - Short Physical Performance Battery (SPPB) 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)
- Secondary Outcome Measures
Name Time Method Health-related Quality of Life 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.
Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs) 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)
Nutritional status 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)
Trial Locations
- Locations (1)
National Geriatric Hospital
🇻🇳Hanoi, Vietnam