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NCT02145949 · ClinicalTrials.gov registry record · Phase 2
Mechanistic Approach to Preventing Atrophy and Restoring Function in Older Adults
A Phase 2 study, sponsored by University of Oregon.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT02145949 is a Phase 2 study that has completed, run by University of Oregon. The registered enrollment target is 80 participants.
The verdict
NCT02145949, a Phase 2 study, has completed, sponsored by University of Oregon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
As a function of the growing population of older adults, an estimated 3.48 million total knee arthroplasty (TKA) procedures will be performed annually in the U.S. by 2030. Despite the near-universal success of this surgery in mitigating chronic knee pain, TKA is not successful in restoring long-term physical function in older adults, primarily because of quadriceps muscle atrophy, which explains 77% of the strength deficits. Overall, strength and functional mobility in TKA patients is 30-50% below age-matched healthy controls. Functional tasks such as stair-climbing remain a clinical problem for 75% of patients following TKA. Muscle atrophy occurs in both operative and non-operative legs, and is essentially permanent for older patients because of their impaired ability to increase muscle mass. The purpose of this clinical research is to determine the effects of essential amino acid (EAA) supplementation on muscle mass, strength, and functional mobility following TKA in older adults. Based on strong preliminary data, the investigators hypothesize that twice-daily ingestion of 23 g of EAA for 1 wk before through 6 wk after TKA will increase basal rates of muscle protein synthesis via inactivation of catabolic signaling, and up-regulation of anabolic and cyto-protective proteins. The investigators further hypothesize that short-term atrophy prevention and accelerated return of functional mobility will lead to longer-term structural and functional adaptations, and improved quality of life in older TKA patients vs. Placebo. Identifying the mechanisms up-regulated by EAA treatment that preserve muscle volume and mobility will have a major impact on rehabilitation science. This study will accomplish two specific aims: (1) determine if EAA elevates basal rates of muscle protein synthesis by up-regulating anabolic pathways and cyto-protective proteins, and inactivating catabolic pathways in the short term vs. Placebo and (2) determine if short-term prevention of atrophy, wea
Interventions
- DRUG Essential Amino Acids (EAA)
- DRUG Placebo (Alanine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-12 |
| Est. Completion | 2020-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02145949
The ClinicalTrials.gov registry entry for NCT02145949 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oregon, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Essential Amino Acids (EAA) is the first listed.
NCT02145949 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02145949 about?
NCT02145949 is a clinical study titled "Mechanistic Approach to Preventing Atrophy and Restoring Function in Older Adults". As a function of the growing population of older adults, an estimated 3.48 million total knee arthroplasty (TKA) procedures will be performed annually in the U.S. by 2030. Despite the near-universal success of this surgery in mitigating chronic knee pain, TKA is not successful in restoring long-term...
What is the current status of trial NCT02145949?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2014-12. Estimated completion is 2020-02.
What interventions are being tested in trial NCT02145949?
The interventions under investigation include: Essential Amino Acids (EAA) (DRUG), Placebo (Alanine) (DRUG).
Who is sponsoring clinical trial NCT02145949?
This trial is sponsored by University of Oregon, which has 63 total clinical trials registered on ClinicalTrials.gov.
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