Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia
- Conditions
- Sarcopenia
- Interventions
- Combination Product: Combined exercise and nutrition interventionOther: Conventional medial care
- Registration Number
- NCT04948736
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 168
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined exercise nutrition intervention group Combined exercise and nutrition intervention Customized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period. Conventional medial care group Conventional medial care Conventional medical care service for 12weeks during intervention period.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Physical performance Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3) Short Physical Performance Battery \[range from 0 to 12 score\]
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)
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
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
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of