This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention.
The definition of sarcopenia is age-related loss of skeletal muscle and physical functions. Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases. In particular, patients with metabolic syndrome showed a high prevalence of muscle loss and muscle weakness. It has been reported exercise in sarcopenia patients not only improved insulin sensitivity and physical performance but also helped the treatment of the diseases. Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients. However, there is still not established standard protocol for the combined exercise-nutrition intervention. Therefore, the aim of this trial is to compare the effects of combined exercise-nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
Combined exercise and nutrition intervention for 12 weeks (an introductory phase 3 weeks, an expanded phase 3 weeks, and a maintenance phase 6 weeks). Exercise intervention (each 60-min session) includes stretching, resistance exercise, and aerobic exercise according to protocol. Nutritional intervention includes investigating dietary habits and calculate insufficient protein intake using Mini Nutritional Aseessment (MNA) and Korean Protein Assessment Tool (KPAT) to provide customized diet and high protein drink.
Conventional medical care service for 12weeks during intervention period. Usual care includes medical check-up and exercise and dietary counseling. They were given a brochure about exercise and protein-rich foods at their first visit. The control group patients maintain their usual amount of activity and diet during the 6-month evaluation period. usual activity and dietary habits.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
5-times chair stand test
Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Physical performance
Short Physical Performance Battery \[range from 0 to 12 score\]
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Gait speed test
measured by 6 meter gait speed
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Appendicular skeletal muscle mass
measured using Dual-energy X-ray absorptiometry (DEXA), Bioelectrical impedance analysis (BIA)
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Health Related Quality of Life
Evaluation of quality of life using EQ-5D \[range from 5 to 25 score\]. Higher value means worse quality of life
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Basic and instrumental activities of daily living
Evaluation of basic and instrumental activities of daily living using Korean Activity of Daily Living (K-ADL), Korean Instrumental Activity of Daily Living (K-IADL) \[range from 0 to 33\]. Low value means poor ability of activities.
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
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Sarcopenia screening questionnaire
Evaluation of quality of life using Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls (SARC-F) questionnair \[range from 0 to 10\].
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Nutritional Assessment
Evaluation of nutritional state using Mini-Nutritional Assessment (MNA) \[range from 1 to 30 score\], Korean Protein Assessment Tool (KPAT)
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Handgrip strength
Evaluation of hand grip strength using Hand-held dynamometer
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Delirium assessment
Evaluation of delirium using Delirium Rating Scale (DRS) \[range from 0 to 32 score\]. Higher value means worse delrious status
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Physical acitivity assessment
measured by Korean Physical Activity Scale for the Elderly (K-PASE) \[range from 0 to 1382.52 score\]. Higher value means better physical status
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Cognitive assessment
Evaluation of cognitive state using Korean Mini Mental Status Examination, 2nd edition (K-MMSE2) \[range from 0 to 30 score\]
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Psychiatric state
Evaluation of psychiatric state using Short Form of Geriatric Depression Scale-Korea (SGDS-K) \[range from 0 to 30 score\]
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Swallowing assessment
measured by Standardized Swallowing Assessment (SSA)
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)
Empowerment assessment
measured by Korean version of Health Empowerment Scale (K-HES) \[range from 8 to 40 score\]. Higher value means better empowerment status
Time frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)