Staying Healthy Through Education and Prevention Study

Disability Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00817193
• Other study ID #: HHSA290200600024
• Secondary ID: 7581700 8-K72PS8
• Status: Active, not recruiting
• Phase: N/A
• First received: January 5, 2009
• Last updated: May 27, 2010
• Start date: January 2009
• Est. completion date: September 2010

Study information

• Verified date: May 2010
• Source: American Association of Homes and Services for the Aging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Disability

Intervention

Behavioral:
• Physical Activity
Physical Activity program
• Wellness
Wellness program

Locations

Country	Name	City	State
United States	Good Samaritan Society - Manzano del Sol	Albuquerque	New Mexico
United States	Good Samaritan Society - Florida Luthern	Deland	Florida
United States	Good Samaritan Society - Denton Village	Denton	Texas
United States	Good Samaritan Society - Fairlawn Village	Gresham	Oregon
United States	Good Samaritan Society - Hastings Village	Hastings	Nebraska
United States	Good Samaritan Society - Kissemmee Village	Kissimmee	Florida
United States	Good Samaritan Society - Loveland Village	Loveland	Colorado
United States	Good Samaritan Society - Mountain Home	Mountain Home	Arkansas
United States	Good Samaritan Society - Cedar Lake Village	Olathe	Kansas
United States	Good Samaritan Society - Westview Acres	Waconia	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
American Association of Homes and Services for the Aging	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: J Gerontol A Biol Sci Med Sci. 2007 Mar;62(3):337. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Physical Performance Battery score		12 months	No
Secondary	Incidence of Falls that result in participant being completely on the ground		12	No
Secondary	Incidence of hospitalization		12 months	No
Secondary	Incidence of Nursing home admission		12 months	No
Secondary	Incidence of emergence room visit		12 months	No