Combined Exercise and Nutrition Intervention for Sarcopenia

Not Applicable

Recruiting

• Conditions: Sarcopenia

• Registration Number: NCT06654648
• Lead Sponsor: Seoul Bumin 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 hip fracture showed a high prevalence of muscle loss and muscle weakness.

It has been reported exercise in sarcopenia patients 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 Timeline

• Study Start: 2022-03-29
• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-22
• Study First Posted: 2024-10-23
• Last Update Posted: 2024-10-24
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)]	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
Physical performance	[Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)]	Short Physical Performance Battery \[range from 0 to 12 score\] The scores range from 0 (worst performance) to 12 (best performance) with higher scores indicating better functionality. It is a group of measures that combines the results of the gait speed, chair stand and balance tests.

Trial Locations

Locations (1)

Seoul Bumin Hospital; 🇰🇷 Seoul, Korea, Republic of