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NCT03410823 · ClinicalTrials.gov registry record · NA
PUSH Plus Protein Pilot for Hip Fracture Patients
A NA study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT03410823: Clinical Trial NA study, sponsored by University of Maryland, Baltimore.
NCT03410823 is a NA study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03410823, a NA study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Hip fracture is a common problem among older individuals. The goal of current standard of care after hip fracture is to achieve independent, household ambulation 2-3 months after surgery, yet decreased functional ability typically persists well beyond three months and many patients never resume independent ambulation outside the home. Previous research has established that one must be able to walk at least 300 meters (\~330 yards) within 6 minutes to re-establish routine interactions in the community, such as going to the store or to church. In part, this is based on the average distance from handicapped parking spaces into most facilities. Activity and exercise are believed to be of benefit for reducing disability in older adults, yet the majority of older adults does not participate in regular exercise and is not active. This is especially true for older adults following hip fracture after they complete the usual rehabilitation program. This research study is being done to test a 16-week, multi-part exercise intervention for hip fracture patients that will be supervised by specially trained physical therapists (PTs). The exercise intervention uses a novel machine to provide strength and endurance training in the home. This has been shown in smaller studies to be safe and effective at increasing strength. The purpose of this small pilot study is to test whether adding a protein supplement to the exercise intervention leads to more improvements in a person's ability to walk in their own home and in the local community. With this knowledge, investigators hope to help a greater number of hip fracture patients enjoy a more complete recovery and improved overall health. In addition to providing important information on adherence, feasibility, and safety, this pilot study of hip fracture patients has the unique advantage of being able to compare data to two recently completed studies where participants received the PUSH intervention without protein supplementation.
Primary Outcome
The Six-Minute Walk Test (SMWT) will be used to obtain a continuous measure of total distance walked in six minutes. The SMWT is highly correlated with workloads, heart rate, oxygen saturation, and dyspnea responses when compared to bicycle ergometry and treadmill exercise tests in older persons. It has been performed by elderly, frail and severely compromised participants who cannot perform standard maximal treadmill or cycle ergometry exercise tests.
Interventions
- DIETARY_SUPPLEMENT Protein
- DIETARY_SUPPLEMENT Nutrition
- BEHAVIORAL PUSH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2020-12-12 |
| Phase | NA |
Why NCT03410823 stopped before completion
NCT03410823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Protein is the first listed.
NCT03410823 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03410823 about?
NCT03410823 is a clinical study titled "PUSH Plus Protein Pilot for Hip Fracture Patients". Hip fracture is a common problem among older individuals. The goal of current standard of care after hip fracture is to achieve independent, household ambulation 2-3 months after surgery, yet decreased functional ability typically persists well beyond three months and many patients never resume inde...
What is the current status of trial NCT03410823?
This trial is currently terminated. It is a NA study. The enrollment target is 20 participants. The study started on 2018-07-16. Estimated completion is 2020-12-12.
What interventions are being tested in trial NCT03410823?
The interventions under investigation include: Protein (DIETARY_SUPPLEMENT), Nutrition (DIETARY_SUPPLEMENT), PUSH (BEHAVIORAL).
Who is sponsoring clinical trial NCT03410823?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03410823's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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