Sarcopenia
Conditions
Keywords
Sarcopenia, Older adults, Exercise, Nutrition, Standard intervention
Brief summary
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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTCombined exercise and nutrition intervention
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.
OTHERConventional medial care
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.
Sponsors
National Evidence-Based Healthcare Collaborating Agency
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients older than 65 years and under 90 years * patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019 * patients who had metabolic syndrome
Exclusion criteria
* patients with less than estimated glomerular filtration rate (eGFR) 30 * patients with musculoskeletal or chronic lung disease incapable of exercise * patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise * patients less than 5 years after treatment of malignant tumor * patients with liver cirrhosis, diabetes and other chronic disease * patients who cannot perform combined exercise nutrition intervention for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-times chair stand test | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Change from baseline 5-times chair stand test to 12 weeks after assessment, measured by 5-times chair stand test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait speed test | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | measured by 6 meter gait speed |
| Appendicular skeletal muscle mass | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | measured using Dual-energy X-ray absorptiometry (DEXA), Bioelectrical impedance analysis (BIA) |
| Health Related Quality of Life | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of quality of life using EQ-5D \[range from 5 to 25 score\]. Higher value means worse quality of life |
| Basic and instrumental activities of daily living | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | 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. |
| Sarcopenia screening questionnaire | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of quality of life using Strength, Assistance with walking, Rising from a chair, Climbing stairs and Falls (SARC-F) questionnair \[range from 0 to 10\]. |
| Nutritional Assessment | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of nutritional state using Mini-Nutritional Assessment (MNA) \[range from 1 to 30 score\], Korean Protein Assessment Tool (KPAT) |
| Physical performance | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Short Physical Performance Battery \[range from 0 to 12 score\] |
| Delirium assessment | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of delirium using Delirium Rating Scale (DRS) \[range from 0 to 32 score\]. Higher value means worse delrious status |
| Physical acitivity assessment | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | measured by Korean Physical Activity Scale for the Elderly (K-PASE) \[range from 0 to 1382.52 score\]. Higher value means better physical status |
| Cognitive assessment | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of cognitive state using Korean Mini Mental Status Examination, 2nd edition (K-MMSE2) \[range from 0 to 30 score\] |
| Psychiatric state | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of psychiatric state using Short Form of Geriatric Depression Scale-Korea (SGDS-K) \[range from 0 to 30 score\] |
| Swallowing assessment | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | measured by Standardized Swallowing Assessment (SSA) |
| Empowerment assessment | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | measured by Korean version of Health Empowerment Scale (K-HES) \[range from 8 to 40 score\]. Higher value means better empowerment status |
| Handgrip strength | Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) | Evaluation of hand grip strength using Hand-held dynamometer |
Countries
South Korea
Outcome results
None listed