Combined Exercise and Nutrition Intervention for Sarcopenia in Patients With Hip Fracture: CENTERS； A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- 5-times chair stand test
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 90 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)])
Investigators
YongChan Ha
The President of Seoul Bumin Hospital
Seoul Bumin Hospital