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NCT01898611 · ClinicalTrials.gov registry record · Phase 2
Ghrelin Plus Strength Training in Frail Elderly Study
A Phase 2 study of Frailty Syndrome, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01898611: Completed Phase 2 study of Frailty Syndrome, sponsored by University of Pennsylvania.
NCT01898611 is a Phase 2 study of Frailty Syndrome that has completed, run by University of Pennsylvania. The registered enrollment target is 16 participants, below the 334-participant average among 4 other Frailty Syndrome trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898611, a Phase 2 study of Frailty Syndrome, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ghrelin
Study Locations (1)
Pennsylvania
- Clinical and Translational Research Center, University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-07-01 |
| Est. Completion | 2016-08-31 |
| Phase | Phase 2 |
What the finished NCT01898611 record still lists
NCT01898611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 334-participant average among 4 other Frailty Syndrome trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Frailty Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01898611 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01898611 about?
NCT01898611 is a clinical study titled "Ghrelin Plus Strength Training in Frail Elderly Study". 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 ...
What is the current status of trial NCT01898611?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-07-01. Estimated completion is 2016-08-31.
What conditions does trial NCT01898611 study?
This clinical trial studies the following conditions: Frailty Syndrome.
What interventions are being tested in trial NCT01898611?
The interventions under investigation include: Placebo (DRUG), Ghrelin (DRUG).
Who is sponsoring clinical trial NCT01898611?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01898611 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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