Ellen F Binder1, Jesse C Christensen2, Jennifer Stevens-Lapsley3, Jenna Bartley4, Sarah D Berry5, Adrian S Dobs6, Richard H Fortinsky4, Kerry L Hildreth7, Douglas P Kiel5, George A Kuchel4, Robin L Marcus2, Christine M McDonough8, Denise Orwig9, David R Sinacore10, Robert S Schwartz7, Elena Volpi11, Jay Magaziner9, Kenneth B Schechtman12. 1. Division of Geriatrics and Nutritional Science, Washington University School of Medicine in St. Louis, St. Louis, MO, United States of America. Electronic address: ebinder@wustl.edu. 2. Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT, United States of America. 3. Department of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Denver, CO, United States of America. 4. UConn Center on Aging, University of Connecticut, Farmington, CT, United States of America. 5. Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Department of Medicine, Beth Isreal Deasconess Medical Center and Harvard Medical School, Boston, MA, United States of America. 6. Department of Medicine, Johns Hopkins Medicine, Baltimore, MD, United States of America. 7. Division of Geriatrics, University of Colorado Anschutz Medical Campus, Denver, CO, United States of America. 8. School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, United States of America. 9. Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, United States of America. 10. Department of Physical Therapy, High Point University, High Point, NC, United States of America. 11. Sealy Center on Aging, University of Texas Medical Branch at Galveston, Galveston, TX, United States of America. 12. Division of Biostatistics, Washington University School of Medicine in St. Louis, St. Louis, MO, United States of America.
Abstract
BACKGROUND: 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.
BACKGROUND: 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.
Authors: Susan R Davis; Michele Moreau; Robin Kroll; Céline Bouchard; Nick Panay; Margery Gass; Glenn D Braunstein; Angelica Linden Hirschberg; Cynthia Rodenberg; Simon Pack; Helga Koch; Alain Moufarege; John Studd Journal: N Engl J Med Date: 2008-11-06 Impact factor: 91.245