Status:
COMPLETED
Ghrelin Plus Strength Training in Frail Elderly Study
Lead Sponsor:
University of Pennsylvania
Conditions:
Frailty Syndrome
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Individuals with three, four or five frailty criteria using the Fried frailty criteria
Exclusion
- Diabetes mellitus or fasting glucose ≥ 126 mg/dL
- Hospitalization for stroke, myocardial infarction, coronary artery bypass graft surgery, vascular surgery in the past six months.
- New York Heart Association Class III or IV congestive heart failure
- Therapy for cancer in the past 12 months, except non-melanoma skin cancer
- BMI ≥ 30 kg/m2
- Current use of corticosteroids other than topical, ophthalmic, and inhaled preparations
- Therapy with megestrol acetate or dronabinol within the last 6 weeks
- Thyroid stimulating hormone measured as \< 0.4 uIU/L or greater than 10uIU/L
- Abnormal liver function tests (LFTs \> 2x upper limit of normal)
- Hemoglobin \< 11g/dL
- Insulin-like growth factor-I (IGF-I) above the age-specific reference range
- History of surgery within the last 30 days
- Hip fracture of hip or knee replacement within the previous 6 months or unable to walk
- Deemed unsafe to participate by one of the study exercise therapists
- Undergoing physical therapy or an exercise program
- Unstable medical or psychological conditions or unstable home or food environment
- Cognitive deficit as defined by a Folstein Mini Mental State Exam score \< 24/30
- Depression (defined as a score of \> 11 on the Geriatric Depression Questionnaire)
- Out of town for \> 1 week during the 12 week study
- Residing outside of a 15 mile radius of University of Pennsylvania Health System
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01898611
Start Date
July 1 2013
End Date
August 31 2016
Last Update
December 11 2019
Active Locations (1)
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1
Clinical and Translational Research Center, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-5160