Staying Healthy Through Education and Prevention Study (STEP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Disability
• Intervention / Treatment: Behavioral: Physical Activity; Behavioral: Wellness

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Mountain Home, Arkansas, United States, 72653
      • Good Samaritan Society - Mountain Home
  • Colorado
    • Loveland, Colorado, United States, 80537
      • Good Samaritan Society - Loveland Village
  • Florida
    • Deland, Florida, United States, 32724
      • Good Samaritan Society - Florida Luthern
    • Kissimmee, Florida, United States, 34746
      • Good Samaritan Society - Kissemmee Village
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Good Samaritan Society - Cedar Lake Village
  • Minnesota
    • Waconia, Minnesota, United States, 55387
      • Good Samaritan Society - Westview Acres
  • Nebraska
    • Hastings, Nebraska, United States, 68901
      • Good Samaritan Society - Hastings Village
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Good Samaritan Society - Manzano del Sol
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Good Samaritan Society - Fairlawn Village
  • Texas
    • Denton, Texas, United States, 76201
      • Good Samaritan Society - Denton Village

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 65
• Currently reside in independent or assisted living units of participating senior housing with services communities and intend to stay at facility without interruption for the next year
• Baseline SPPB scores between 3 and 9, inclusive.

Exclusion Criteria:

• Age < 65
• Severe cognitive impairment and/or inability to participate actively in the consent process (as determined by research staff).
• Myocardial infarction, stroke, hip fracture, hip or knee replacement, major heart surgery, including valve replacement or bypass surgery, or blood clot in leg or lungs in the previous 3 months.
• Self-reported inability to walk 13 feet with or without an assistive device
• Refusal to participate in the consenting process
• Failure to complete or attempt any of the 3 components of the SPPB for any non-physical reason
• SPPB scores less than 3 or more than 9.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity; Participants will begin to participate in walking sessions and strength building classes that will be offered at each location. Participants will be asked to attend a minimum of 1 strength class per week, with a target of doing 150 minutes of moderate exercise each week. The exercise classes will include stretching and counseling to help participants understand and address the barriers to becoming and staying involved in regular exercise.	Behavioral: Physical Activity; Physical Activity program; Other Names: Exercise
Active Comparator: Wellness; Participants will begin to participate in a wellness program that will meet at each site twice per month. The first meeting will involve a lecture or presentation on a wellness-related topic. The second meeting will follow-up on concepts that were introduced in the first meeting, and will also to provide participants an opportunity to share experiences. Participants will be asked to attend both wellness sessions each month for whole year that the program is running.	Behavioral: Wellness; Wellness program; Other Names: Active control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Short Physical Performance Battery score	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Falls that result in participant being completely on the ground	12
Incidence of hospitalization	12 months
Incidence of Nursing home admission	12 months
Incidence of emergence room visit	12 months

Collaborators and Investigators

• Sponsor: American Association of Homes and Services for the Aging
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Helaine Resnick, PhD, American Association of Homes and Services for the Aging

Publications and helpful links

General Publications

• LIFE Study Investigators, Pahor M, Blair SN, Espeland M, Fielding R, Gill TM, Guralnik JM, Hadley EC, King AC, Kritchevsky SB, Maraldi C, Miller ME, Newman AB, Rejeski WJ, Romashkan S, Studenski S. Effects of a physical activity intervention on measures of physical performance: Results of the lifestyle interventions and independence for Elders Pilot (LIFE-P) study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1157-65. doi: 10.1093/gerona/61.11.1157. Erratum In: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): September 1, 2010
• Study Completion (Anticipated): September 1, 2010

Study Registration Dates

• First Submitted: January 5, 2009
• First Submitted That Met QC Criteria: January 5, 2009
• First Posted (Estimate): January 6, 2009

Study Record Updates

• Last Update Posted (Estimate): May 28, 2010
• Last Update Submitted That Met QC Criteria: May 27, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Aging; Clinical trial; Disability; Short Physical Performance Battery; Senior Housing
• Other Study ID Numbers: HHSA290200600024; 7581700 8-K72PS80 25505