Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia (MENTORS)

Seoul National University

Status: Completed

Conditions: Sarcopenia

Treatments: Other: Conventional medial care; Combination Product: Combined exercise and nutrition intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04948736

B-2010/645-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Combined exercise nutrition intervention group

Experimental group

Description:

Customized exercise and nutrition intervention by underlying disease and functional state for 12 weeks during intervention period.

Treatment:

Combination Product: Combined exercise and nutrition intervention

Conventional medial care group

Active Comparator group

Description:

Conventional medical care service for 12weeks during intervention period.

Treatment:

Other: Conventional medial care