Table 1.

Inclusion and exclusion criteria.

Inclusion criteria

•Female 65 years and older.

•Surgical repair of a non-pathologic fracture of the proximal femur

•Surgical repair date that is within 22 weeks at the first screening visit

•Modified Physical Performance Score (mPPT) of 12–28.

•Serum total testosterone level < 60 ng/dL.

•Community-dwelling or in Assisted Living prior to the hip fracture.

Exclusion criteria

•Cognitive impairment or dementia of severity sufficient to interfere with ability to provide informed consent or fully participate in the study, or a score of ≥11 on the Short Blessed Test of Orientation, Memory and Concentration.

•Use of progestin or androgen containing compound within the previous 6 months.

•Visual or hearing impairments that interfere with following directions for research procedures.

•Active or unstable cardiopulmonary disease (recent myocardial infarction, unstable angina, congestive heart failure class III or IV) within prior 6 months, which would limit full participation in this study.

•Uncontrolled hypertension, defined as a systolic BP > 160 mmHg or diastolic BP > 95 mmHg, on at least two occasions.

•Respiratory disease requiring chronic continuous oxygen therapy, or oxygen therapy during walking or exercise, which would limit full participation in this study.

•History of: a) Breast, ovarian, endometrial or cervical cancer with diagnosis within the previous 10 years; b) Breast, ovarian, endometrial or cervical cancer of Stage 2 or higher.

•Erythrocytosis with hematocrit ≥51% at all sites except at Denver or Salt Lake City sites, or ≥ 52% at the Denver or Salt Lake City sites.

•Severe anemia defined as Hgb < 7 g/dL.

•Uncontrolled diabetes defined as HgbA1C > 10%.

•Geriatric Depression Scale-Short Form score ≥ 12 at the screening assessment.

•Elevated liver transaminase or alkaline phosphatase levels ≥2.5 times above normal range.

•History of HIV or active viral hepatitis.

•Recent history of alcohol or substance abuse, or current alcohol intake of ≥10 drinks/week.

•Untreated or unstable thyroid disease, with serum TSH level ≥ 10 mIU/L or ≤ 0.4 mlU/L.

•Current use of aldactone, flutamide or leflunomide.

•Treatment with systemic corticosteroids (daily dose >5 mg prednisone or equivalent) for at least 90 days within the previous 12 months.

•Musculoskeletal or neurological conditions that limit full participation in this study, could be made worse by exercise training, or not expected to improve with exercise.

•End Stage Renal Disease on dialysis or GFR < 15 mL/min.

•History of idiopathic deep venous thrombosis or pulmonary embolus (i.e., not related to period or immobilization or surgery), recurrent or multiple venous thrombi; history of a hypercoagulable state such as Factor V Leiden thrombophilia.

•Lower extremity amputation other than toes.

•Planned joint surgery during the intervention period.

•Severe lower extremity pain or ulceration that could limit full participation in this study.

•Allergy to gel components.

•Residence too far from research center (specific distance to be determined by each site), or planned travel greater than 2 weeks within the next 9 months.

•Anticipated to be permanently living in a nursing home at the time of randomization.

•Site investigator's judgment that the participant would not be able to complete research procedures or interventions.

•Participation in another research study that in the site investigator's judgment could interfere or conflict with STEP-HI research assessments or interventions.