Clinical trial NCT01898611: Ghrelin Plus Strength Training in Frail Elderly Study
Official title: Ghrelin Plus Strength Training in Frail Elderly Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Frailty Syndrome
Keywords: Frailty
Sarcopenia
Weight Loss
Exercise
Aging
Ghrelin
Elderly
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 16
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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

Primary outcomes:
measure: Change in the Short Physical Performance Battery (SPPB)
timeFrame: Baseline to 12 weeks
measure: Treatment-associated Adverse Events
timeFrame: Twelve weeks
Secondary outcomes:
measure: Change in Weight
timeFrame: Baseline to twelve weeks
measure: Change in Lean Body Mass
timeFrame: Baseline to 12 weeks
measure: Change in Muscle Strength
timeFrame: Baseline to 12 weeks
measure: Change in Food Intake
timeFrame: Baseline to 12 weeks.
measure: Change in Quality of Life
timeFrame: Baseline to 12 weeks.
measure: Change in Frailty Status
timeFrame: Baseline to 12 weeks.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Clinical and Translational Research Center, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Perelman School of Medicine, Department of Medicine, Division of Endocrinology, Diabetes, and Metabolism
name: Anne R. Cappola, M.D.,Sc.M.
role: PRINCIPAL_INVESTIGATOR
References: