Frailty is a geriatric syndrome leading to physical deterioration including muscle wasting (sarcopenia) and unintentional weight loss. There are currently no approved therapies for frailty. Ghrelin is a hormone produced by the stomach that stimulates appetite centers in the brain. The investigators already know that a single dose of Ghrelin improves food intake immediately after the dose in frail older people. In addition, exercise programs have been shown to improve strength and function in older people. In this study, the investigators are trying to find out if a joint intervention of ghrelin and resistance training will improve walking, balance and leg strength in frail elderly people.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
16
Ghrelin
Saline will be used as a placebo
Clinical and Translational Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Change in the Short Physical Performance Battery (SPPB)
The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.
Time frame: Baseline to 12 weeks
Treatment-associated Adverse Events
Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).
Time frame: Twelve weeks
Change in Weight
Change in weight from baseline to 12 weeks
Time frame: Baseline to twelve weeks
Change in Lean Body Mass
Total lean body mass by dual energy x-ray absorptiometry
Time frame: Baseline to 12 weeks
Change in Muscle Strength
One repetition max bench press
Time frame: Baseline to 12 weeks
Change in Food Intake
Change in food intake by 3-day food intake record
Time frame: Baseline to 12 weeks.
Change in Quality of Life
Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points
Time frame: Baseline to 12 weeks.
Change in Frailty Status
According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty
Time frame: Baseline to 12 weeks.
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