Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries

Approximately one-third of older adults fall each year and fall-related injuries are a leading cause of death and disability among this rapidly expanding age group. Despite the availability of bisphosphonates to reduce fractures, concerns over side effects have dramatically reduced use, suggesting that other treatment options are needed. Though many smaller studies have shown that physical activity programs can reduce falls, no study has been adequately powered to detect a reduction in fall-related injuries. We present the design of a three-year randomized controlled clinical trial of 1130 adults age 65 and older with a past history of fragility fractures (e.g., vertebral, fall-related). The main aim is to determine the impact of a community-based multicomponent (strength, balance, aerobic) physical activity program led by trained volunteers (or delivered via DVD) and accompanied by coaching and oversight, by telephone and in-person, by a fitness professional. The main outcome measure is serious fall-related injuries. Secondary outcomes include health care utilization, bone and muscle mass, loneliness, health-related quality of life and mood. The study represents the first large clinical trial of a comprehensive physical activity program to reduce secondary injuries among patients with a history of fragility fracture.