Staying Healthy Through Education and Prevention Study (STEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817193
Recruitment Status : Unknown
Verified May 2010 by American Association of Homes and Services for the Aging.
Recruitment status was:  Active, not recruiting
First Posted : January 6, 2009
Last Update Posted : May 28, 2010
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
American Association of Homes and Services for the Aging

Brief 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.

Condition or disease Intervention/treatment Phase
Disability Behavioral: Physical Activity Behavioral: Wellness Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Screening and Exercise for Prevention of Disability in Persons Residing in Continuing Care Retirement Communities
Study Start Date : January 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 Name: Active control

Primary Outcome Measures :
  1. Short Physical Performance Battery score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Incidence of Falls that result in participant being completely on the ground [ Time Frame: 12 ]
  2. Incidence of hospitalization [ Time Frame: 12 months ]
  3. Incidence of Nursing home admission [ Time Frame: 12 months ]
  4. Incidence of emergence room visit [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817193

United States, Arkansas
Good Samaritan Society - Mountain Home
Mountain Home, Arkansas, United States, 72653
United States, Colorado
Good Samaritan Society - Loveland Village
Loveland, Colorado, United States, 80537
United States, Florida
Good Samaritan Society - Florida Luthern
Deland, Florida, United States, 32724
Good Samaritan Society - Kissemmee Village
Kissimmee, Florida, United States, 34746
United States, Kansas
Good Samaritan Society - Cedar Lake Village
Olathe, Kansas, United States, 66061
United States, Minnesota
Good Samaritan Society - Westview Acres
Waconia, Minnesota, United States, 55387
United States, Nebraska
Good Samaritan Society - Hastings Village
Hastings, Nebraska, United States, 68901
United States, New Mexico
Good Samaritan Society - Manzano del Sol
Albuquerque, New Mexico, United States, 87108
United States, Oregon
Good Samaritan Society - Fairlawn Village
Gresham, Oregon, United States, 97030
United States, Texas
Good Samaritan Society - Denton Village
Denton, Texas, United States, 76201
Sponsors and Collaborators
American Association of Homes and Services for the Aging
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Helaine Resnick, PhD American Association of Homes and Services for the Aging

Responsible Party: Helaine Resnick, PhD, Director of Research, American Association of Homes and Services for the Aging Identifier: NCT00817193     History of Changes
Other Study ID Numbers: HHSA290200600024
7581700 8-K72PS80 25505
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: May 28, 2010
Last Verified: May 2010

Keywords provided by American Association of Homes and Services for the Aging:
Clinical trial
Short Physical Performance Battery
Senior Housing