Status:
TERMINATED
PUSH Plus Protein Pilot for Hip Fracture Patients
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Hip Fracture
Eligibility:
All Genders
60+ years
Phase:
NA
Brief 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 decrease...
Detailed Description
A pilot study including 20 older adults who have experienced a hip fracture will be carried out with participants receiving a specific multi-component intervention with protein supplementation (PUSH P...
Eligibility Criteria
Inclusion
- Closed fracture of proximal femur
- Age 60 or older at time of baseline testing
- Minimal trauma fracture
- Non-pathologic fracture
- Surgical fixation of fracture
- Living in the community at time of fracture
- Ambulating without human assistance 2 months prior to fracture
- Unable to walk 300 m or more in 6 minutes without human assistance at time of baseline testing
Exclusion
- Not English speaking
- Does not live within reasonable distance of the clinical center
- End stage renal disease on dialysis
- Recent myocardial infarction
- Uncompensated congestive heart failure
- Lower extremity amputation
- Symptoms of angina pectoris
- Chest pain or shortness of breath (including from severe COPD)
- Participant plans to move out of area or otherwise be unavailable during the 16-week intervention period
- Participation in another clinical trial
- Not community-residing (e.g., resident of a skilled nursing facility) at time of baseline testing
- Not fully weight-bearing on fractured leg or non-fractured leg at time of baseline testing
- Calculated creatinine clearance \< 15 ml/min
- Serum albumin \< 2.5 g/dl
- Hemoglobin \< 9 g/dl
- Receiving physical therapy for the hip fracture in the hospital or inpatient rehabilitation facility at time of baseline testing
- Severely diminished lower extremity sensation or ulceration
- Uncontrolled hypertension
- Chronic kidney disease
- Severe liver disease (e.g., hepatitis, fatty liver disease, cirrhosis)
- Poorly controlled and/or insulin-dependent diabetes
- Known dairy allergy
- Denied medical clearance by appropriate medical provider
- Clinical site clinician thinks participant is not a good candidate for study (e.g., not likely to survive study period)
- Cognitive impairment (3MS score \<73)
- Development of chest pain or substantial shortness of breath or ambulating with severe pain during baseline SMWT
- Participant walks less than 4 meters in 40 seconds (\<0.1 m/sec) during baseline SMWT
- Baseline testing not done by 26 weeks post admission for hip fracture
- Final sign-off from study clinician and/or principal investigator is incomplete
- Incomplete baseline data
- Unable to contact participant
- Participant is unable to provide her/his own informed consent
- Participant refuses the study
Key Trial Info
Start Date :
July 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03410823
Start Date
July 16 2018
End Date
December 12 2020
Last Update
November 26 2024
Active Locations (2)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
2
University of Maryland - St. Joseph Medical Center
Towson, Maryland, United States, 21204