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Clinical Trials/NCT06654648
NCT06654648
Recruiting
N/A

Combined Exercise and Nutrition Intervention for Sarcopenia in Patients With Hip Fracture: CENTERS; A Multicenter Randomized Controlled Trial

Seoul Bumin Hospital1 site in 1 country118 target enrollmentMarch 29, 2022
ConditionsSarcopenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Seoul Bumin Hospital
Enrollment
118
Locations
1
Primary Endpoint
5-times chair stand test
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2022
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Seoul Bumin Hospital
Responsible Party
Principal Investigator
Principal Investigator

YongChan Ha

The President of Seoul Bumin Hospital

Seoul Bumin Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

5-times chair stand test

Time Frame: [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 Outcomes

  • Physical performance([Time Frame: Screening (visit 0), Baseline (visit 1), 12 weeks after intervention (visit 2), 24 weeks after intervention (visit 3)])

Study Sites (1)

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