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Symposium

Interdisciplinary

The Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI) Trial: Study Results and Implications

Wednesday, November 13, 2024
10:00 AM – 11:30 AM PST
Location: Room 609
CE: 1.5

Hip fractures are common among older women and can have a devastating impact on their ability to remain independent. Many women who were high functioning before the hip fracture do not return to their pre-fracture level of function, have persistent weakness and mobility impairments, and may require ongoing supportive services. Age-associated androgen deficiency may contribute to deficits in muscle mass, strength and power that are common in older female hip fracture patients. The typical approach to hip fracture rehabilitation routinely includes a limited course of physical therapy but the precise role of exercise and the use of an anabolic therapy like testosterone has not been determined. The Starting a Testosterone and Exercise Program after Hip Injury (STEP-HI) Study is a three-group, randomized, double-blinded, placebo-controlled Phase III clinical trial that was conducted at 8 clinical sites in the USA. The trial was designed to evaluate a multi-modal intervention aimed at improving functional outcomes in older female hip fracture patients with persistent mobility impairment. 129 female hip fracture patients, age 65 yrs. and older were randomly assigned to one of three groups: supervised exercise plus 1% testosterone topical gel (EX+T); supervised exercise plus placebo gel (EX+P); or Enhanced Usual Care (EUC). This symposium will present the results of the trial, including recruitment and retention, primary and secondary outcome measures. The program will also address strategies to ensure fidelity with exercise in a multicenter study like STEP-HI. Implications of study findings for future research and clinical practice will be discussed.

Learning Objectives:

  • After attending this session participants will be able to describe the design of the STEP-HI study, including the strategy to combine testosterone therapy and exercise in frail women with a recent hip fracture.
  • After attending this session participants will be able to describe the results of the STEP-HI study, including the changes in the primary study outcome (Six Minute Walk Distance), and changes in secondary outcomes measures, including SPPB score, Leg Press, lean body mass, and quality of life measures.
  • After attending this session participants will be able to describe strategies to maintain fidelity to a supervised exercise intervention across multiple sites and locations.

Presentations:

  • 10:00 AM – 11:30 AM PST
    The STEP-HI Study: Recruitment, Adherence, and Results for Primary Study Outcome

    Individual Symposium Abstract First Author: Ellen F. Binder, MD (she/her/hers) – Washington University School of Medicine

  • 10:00 AM – 11:30 AM PST
    The STEP-HI Study: Impact of Testosterone and Resistance Exercise on SPPB, Leg Strength, and Appendicular Lean Mass

    Individual Symposium Abstract First Author: Elena Volpi, MD, PhD, FGSA – University of Texas Health San Antonio

  • 10:00 AM – 11:30 AM PST
    Delivering High-Intensity Strength Training and Maintaining Intervention Fidelity: The STEP-HI Study

    Individual Symposium Abstract First Author: Michelle R. Rauzi, PT, DPT, PhD, ATC (she/her/hers) – Department of Veterans Affairs