STEP-HI: Hip Fracture Recovery Research Study

STUDY BASICS

Are you a woman age 65 or older who had surgery to repair a hip fracture within the past five months? You may be eligible to participate in a research study to help find out if an exercise program, with or without hormone replacement therapy, improves physical functioning after a hip fracture. Transportation is provided.

STUDY PURPOSE

Following surgery for a hip fracture, many older women experience weakened muscles and bones, which can lead to significant mobility problems and a reduced quality of life. Some research suggests that the hormone testosterone may improve physical functioning after a hip fracture, but this relationship is not fully understood.  

The purpose of this study is to find out if a six-month course of exercise, combined with low dose testosterone gel therapy, can improve physical function after a hip fracture more effectively than supervised exercise alone or a home-based exercise program. Researchers hope their findings lead to better outcomes for people who have hip fractures in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 65 and up
• Had surgery to repair a fractured hip within the past 5 months

WHAT PARTICIPANTS CAN EXPECT

Eligible participants will be randomly assigned (like drawing straws) to one of three exercise groups. Group 1 participants receive home exercise program that includes a monthly review with an exercise trainer and health education sessions.  Group 2 and Group 3 participants attend a supervised exercise program and are prescribed a topical gel that is applied to their skin daily. The topical gel will contain either testosterone or an inactive gel (placebo). Eight (8) of 9 participants will be randomized to Group 2 or 3. The supervised exercise program is conducted at University of Pittsburgh and focuses on strength and resistance training. Participants attend 2 sessions per week for 6 months. Each session lasts about 1 hour. Participants also perform some exercise at home.

Assessments will occur every three months. All participants will also receive nutritional counseling and vitamin D and calcium supplements at no cost for the duration of the study. Transportation provided for all visits.