Evaluating Resistance Training for Sarcopenia in Older Patients With Type 2 Diabetes: Treatment Outcomes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcopenia
- Sponsor
- National Geriatric Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Muscle mass
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Trinh Ngoc Anh
Endocrinologist, Principal Investigator and Sponsor
National Geriatric Hospital
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)
Outcomes
Primary Outcomes
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.
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.
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)
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)
Secondary Outcomes
- Health-related Quality of Life(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)(Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12))
- Nutritional status(Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12))