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dc.contributor.authorBinder, Ellen F
dc.contributor.authorChristensen, Jesse C
dc.contributor.authorStevens-Lapsley, Jennifer
dc.contributor.authorBartley, Jenna
dc.contributor.authorBerry, Sarah D
dc.contributor.authorDobs, Adrian S
dc.contributor.authorFortinsky, Richard H
dc.contributor.authorHildreth, Kerry L
dc.contributor.authorKiel, Douglas P
dc.contributor.authorKuchel, George A
dc.contributor.authorMarcus, Robin L
dc.contributor.authorMcDonough, Christine M
dc.contributor.authorOrwig, Denise
dc.contributor.authorSinacore, David R
dc.contributor.authorSchwartz, Robert S
dc.contributor.authorVolpi, Elena
dc.contributor.authorMagaziner, Jay
dc.contributor.authorSchechtman, Kenneth B
dc.date.accessioned2021-05-03T12:26:16Z
dc.date.available2021-05-03T12:26:16Z
dc.date.issued2021-03-11
dc.identifier.urihttp://hdl.handle.net/10713/15547
dc.description.abstractBackground: Up to 75% of hip fracture patients never recover to their pre-fracture functional status. Supervised exercise that includes strength training can improve functional recovery after hip fracture. The role of testosterone replacement for augmenting the effects of exercise in older women after hip fracture is unknown. Methods: The Starting Testosterone and Exercise after Hip Injury (STEP-HI) Study is a 6-month Phase 3 multicenter randomized placebo-controlled trial designed to compare supervised exercise (EX) plus 1% testosterone topical gel, with EX plus placebo gel, and with enhanced usual care (EUC). Female hip fracture patients age ≥ 65 years are being recruited from clinical centers across the United States. Participants are community dwelling and enrolled within 24 weeks after surgical repair of the fracture. The EX intervention is a center-based program of progressive resistance training. The EUC group receives a home exercise program and health education. Participants receive dietary counseling, calcium and vitamin D. The primary outcome is the Six Minute Walk Distance. Secondary outcomes include physical performance measures, self-reported function and quality of life, and dual energy x-ray absorptiometry measures of body composition and bone mineral density. Results: Enrollment, interventions, and follow-up are ongoing. We describe the impact of the coronavirus disease 2019 pandemic on the trial, including modifications made to allow continuation of the interventions and outcome data collection using remote video and audio technology. Conclusions: Results from the STEP-HI study are expected to have important clinical and public health implications for management of the growing population of hip fracture patients.en_US
dc.description.urihttps://doi.org/10.1016/j.cct.2021.106356en_US
dc.language.isoenen_US
dc.publisherElsevier Inc.en_US
dc.relation.ispartofContemporary Clinical Trialsen_US
dc.rightsCopyright © 2021 Elsevier Inc. All rights reserved.en_US
dc.subjectFrailtyen_US
dc.subjectHip fractureen_US
dc.subjectRehabilitationen_US
dc.subjectSarcopeniaen_US
dc.subjectTestosteroneen_US
dc.titleA multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemicen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.cct.2021.106356
dc.identifier.pmid33716173
dc.source.volume104
dc.source.beginpage106356
dc.source.endpage
dc.source.countryUnited States


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