Juven
DrugNutritional supplements
Other names: Conditionally essential amino acids
NCT Number: NCT05971173
The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.
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Notify Me65 year–89 year
All sexes
Interventional
Early Phase 1
UT Health San Antonio Department of Orthopedics, San Antonio, Texas, United States
This collaborative pilot study is led by a PI who is a board-certified orthopaedic surgeon with extensive experience in the care of older adults with hip fractures. In addition, the multidisciplinary study team includes a research health scientist with vast experience in nutrition, preventive health, and gerontology. The study team will also be supported by a physical therapist and researcher in the field of rehabilitation of older adults with musculoskeletal disorders. Furthermore, an occupational therapist with expertise in rehabilitation science, conduct of pilot studies, and analysis of interview data will play an important role in this study. Moreover, the statistical analyses will be performed by an expert statistical consultant from our institution, who will be reimbursed on a fee for service basis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional supplements
Other names: Conditionally essential amino acids
Over the counter nutritional supplement
Other names: Multivitamin/multimineral
Time frame: 26 weeks (post surgery)
Number of subjects that experienced any complications post surgery
Time frame: 26 weeks (post surgery)
Number of hospital re-admissions
Time frame: 26 weeks (post surgery)
Number of secondary fractures that occurred post surgery
Time frame: Baseline to 26 weeks
Change in grip strength from pre- to post-surgery using a hand dynamometer and measured in pounds
Time frame: Baseline to 26 weeks
Change in Health related quality of life (QOL) survey, a 36 item survey. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
The University of Texas Health Science Center at San Antonio
Other
Nutritional Optimization and Bone Health Management for Older Adults Undergoing Hip Fracture Surgery: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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