The STEP-HI Trial: Pragmatic Challenges and Design Issues

Abstract Multi-modal interventions present many implementation challenges, especially for studies of frail older adults. The STEP-HI study is an ongoing multi-center, randomized, controlled, double-blinded clinical trial that is evaluating whether six months of topical testosterone therapy combined with a supervised center-based exercise-training program can improve mobility, functional performance, and quality of life after hip fracture, compared to exercise training alone or Enhanced Usual Care. Female hip fracture patients ≥ 65 yrs. old who are living in the community or assisted living are being randomized within 26 weeks of surgical repair for the fracture, and re-evaluated 24 weeks later. This presentation discusses the rationale and study design, and modifications to the protocol in response to challenges, including the COVID-19 pandemic.

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STARTING A TESTOSTERONE AND EXERCISE PROGRAM AFTER HIP INJURY (STEP-HI) TRIAL: RATIONALE, METHODS, AND FIDELITY

Innovation in Aging ◽

10.1093/geroni/igz038.1568 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

pp. S420-S420

Author(s):

Ellen Binder

Keyword(s):

Hip Fracture ◽

Exercise Training ◽

Assisted Living ◽

Functional Performance ◽

Exercise Program ◽

Innovative Methods ◽

Hip Injury ◽

Exercise Training Program ◽

The Usa ◽

Double Blinded

Abstract The STEP-HI study is an ongoing multi-center, randomized, controlled, double-blinded clinical trial that is evaluating whether six months of topical testosterone therapy combined with a supervised center-based exercise-training program can improve mobility, functional performance, and quality of life after hip fracture, compared to exercise training alone or Enhanced Usual Care. Female hip fracture patients ≥ 65 yrs. old who are living in the community or assisted living are being randomized within 16 weeks of surgical repair for the fracture, and re-evaluated 24 weeks later. Three hundred patients will be recruited from six clinical centers in the USA. This presentation discusses the rationale and study design, including innovative methods for fidelity monitoring of exercise procedures across the clinical sites. Strategies for recruitment and related challenges will be discussed. Preliminary enrollment and fidelity data will be presented.

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A Clinician Referral and 12-Week Exercise Training Program for Men With Prostate Cancer: Outcomes to 12 Months of the ENGAGE Cluster Randomized Controlled Trial

Journal of Physical Activity and Health ◽

10.1123/jpah.2016-0431 ◽

2017 ◽

Vol 14 (5) ◽

pp. 353-359 ◽

Cited By ~ 10

Author(s):

Cadeyrn J. Gaskin ◽

Melinda Craike ◽

Mohammadreza Mohebbi ◽

Kerry S. Courneya ◽

Patricia M. Livingston

Keyword(s):

Physical Activity ◽

Prostate Cancer ◽

Exercise Training ◽

Training Program ◽

Controlled Trial ◽

Vigorous Physical Activity ◽

Randomized Controlled ◽

Exercise Training Program ◽

Cluster Randomized

Background:The ENGAGE (efficacy of a referral and physical activity program for survivors of prostate cancer) study established that a clinician referral and 12-week exercise training program increased vigorous physical activity at 12 weeks among men with prostate cancer. Here, we report the 6- and 12-month outcomes.Methods:In this multicenter cluster randomized controlled trial, we compared a clinician referral and exercise training program to usual care. Discounted gym membership was offered to men in the intervention condition on completion of the 12-week exercise program. Self-reported physical activity at 6 and 12 months was the primary outcome. Quality of life, anxiety, and depressive symptoms were secondary outcomes.Results:A total of 147 men meeting eligibility criteria agreed to participate (54 intervention, 93 control). A positive interaction effect for vigorous physical activity was observed at 6 months, but not 12 months. No significant effects for the secondary outcomes were found.Conclusions:A clinician referral and community-based supervised and unsupervised exercise training program, along with discounted gym membership, had a positive short-term effect on vigorous physical activity levels, but did not improve quality of life, in men with prostate cancer.

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