NCT04948736

Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia

Effectiveness and Clinical Application of Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenic Older Adults With Metabolic Syndrome: Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcopenia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combined 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.
OTHER	Conventional 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.

Timeline

• Start date: 2022-03-08
• Primary completion: 2024-07-11
• Completion: 2025-07-31
• First posted: 2021-07-02
• Last updated: 2025-09-09

Locations

1 site across 1 country: South Korea