Diabetes, Sarcopenia
Conditions
Keywords
Sarcopenia, Diabetes, Resistance training
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.
Interventions
BEHAVIORALProgressive 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 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.
Sponsors
National Geriatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Vietnam
Contacts
Primary ContactAnh N Trinh, MD
Backup ContactTam N Nguyen, PhD
Outcome results
None listed