Ghrelin Plus Strength Training in Frail Elderly Study
Condition: Frailty Syndrome
MeSH terms: Frailty
Intervention: Ghrelin; Placebo
Intervention description: Ghrelin; Saline will be used as a placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: Frailty; Sarcopenia; Weight Loss; Exercise; Aging; Ghrelin; Elderly

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 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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals with three, four or five frailty criteria using the Fried frailty criteria

        Exclusion Criteria:

          1. Diabetes mellitus or fasting glucose ≥ 126 mg/dL

          2. Hospitalization for stroke, myocardial infarction, coronary artery bypass graft
             surgery, vascular surgery in the past six months.

          3. New York Heart Association Class III or IV congestive heart failure

          4. Therapy for cancer in the past 12 months, except non-melanoma skin cancer

          5. BMI ≥ 30 kg/m2

          6. Current use of corticosteroids other than topical, ophthalmic, and inhaled
             preparations

          7. Therapy with megestrol acetate or dronabinol within the last 6 weeks

          8. Thyroid stimulating hormone measured as < 0.4 uIU/L or greater than 10uIU/L

          9. Abnormal liver function tests (LFTs > 2x upper limit of normal)

         10. Hemoglobin < 11g/dL

         11. Insulin-like growth factor-I (IGF-I) above the age-specific reference range

         12. History of surgery within the last 30 days

         13. Hip fracture of hip or knee replacement within the previous 6 months or unable to walk

         14. Deemed unsafe to participate by one of the study exercise therapists

         15. Undergoing physical therapy or an exercise program

         16. Unstable medical or psychological conditions or unstable home or food environment

         17. Cognitive deficit as defined by a Folstein Mini Mental State Exam score < 24/30

         18. Depression (defined as a score of > 11 on the Geriatric Depression Questionnaire)

         19. Out of town for > 1 week during the 12 week study

         20. Residing outside of a 15 mile radius of University of Pennsylvania Health System