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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
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.
National Geriatric Hospital
Hanoi, Vietnam
RECRUITINGPhysical performance 1 - Handgrip strength
Handgrip strength is assessed using a hand dynamometer named Jamar Hydraulic Hand Dynamometer: the higher number the better outcome.
Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Physical performance 2 - Gait speed
4-metre gait speed test (the shorter time the better outcome)
Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Physical performance 3 - Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery developed by the National Institute on Aging: scores ranging from 0 (worst) to 12 (best)
Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Muscle mass
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.
Time frame: Prior to the start of intervention, after 4 weeks, 8 weeks and 12 weeks (completion of the intervention)
Nutritional status
Nutritional status is assessed using the Mini Nutritional Assessment Short-Form (MNA-SF): scores ranging from 0 (worst) to 14 (best)
Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)
Health-related Quality of Life
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.
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Time frame: 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)
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)
Time frame: Prior to the start of intervention (Week 0), following the completion of the intervention (Week 12)