Staying Healthy Through Education and Prevention Study — STEP  

Disability Clinical Trial

Official title: Early Screening and Exercise for Prevention of Disability in Persons Residing in Continuing Care Retirement Communities

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to test the effectiveness of a structured physical activity program, relative to a wellness program, in preventing the onset and progression of disability in the setting of senior housing communities, which are sometimes called housing with services.

Clinical Trial Description

As the baby boom population ages, a large number of older adults have found that continuing care retirement communities (CCRCs) offer an attractive residential option. These communities include independent apartments, assisted living and skilled nursing options and often provide a menu of wellness services and a "safety net" of higher level care if/when that care is needed. CCRCs have proliferated in recent years and the number of older adults selecting this residential option is expected to continue. CCRCs represent a largely untapped provider setting in which interventions that have been proven effective in clinically-oriented, controlled studies of community-dwelling elderly can be translated into practice.

Multiple randomized studies have shown the benefits of physical activity interventions such as resistance and endurance exercises on a number of performance measures including walking speed, balance and ability to stand from a chair. These studies have shown that if given an exercise program matched to their needs, the onset and progression of disability can be decreased among persons who are identified at high risk of disability. However, most data supporting the beneficial effect of exercise in old age have been generated from studies conducted in highly controlled clinical trial settings, not in "real world" provider settings in which older adults live and function day-to-day. Thus, it is not known if screening for disability and implementing an exercise program among high risk elders can be effectively implemented in residential settings in a manner that not only promotes health and prevents disability, but that is also attractive to providers from a business standpoint and that can be incorporated into typical staffing patterns.

The American Association of Homes & Services for the Aging (AAHSA) is conducting a trial that builds on a strong evidence base of the beneficial effect of exercise in old age in an effort to accelerate translation of research into practice in CCRCs. The trial will screen CCRC residents for disability using a short set of performance measures called the Short Physical Performance Battery (SPPB). After identification of persons at risk for disability, we will enroll 320 CCRC residents to a program of moderate exercise or an active control arm focused on general wellness. The primary study endpoint is the SPPB score. Secondary endpoints include falls; hospitalizations, and death.

A key feature of the current proposal is that it seeks to extend findings from clinical studies into routine practice in the CCRC setting. This represents true translation of research into practice, and will offer providers an evidence base upon which to make informed decisions.

The trial will take place in 8 CCRCs operated by the Good Samaritan Society, the largest nonprofit provider of services to older adults in the country. Because of its large size and existing dissemination capacity, Good Samaritan is in a unique position to take a leadership role among aging services providers in terms of dissemination of effective, innovative programs in diverse residential settings, including CCRCs. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Disability

• NCT number: NCT00817193
• Study type: Interventional
• Source: American Association of Homes and Services for the Aging
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2009
• Completion date: September 2010