Clinical trial NCT00817193: Staying Healthy Through Education and Prevention Study
Official title: Early Screening and Exercise for Prevention of Disability in Persons Residing in Continuing Care Retirement Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability
Keywords: Clinical trial
Short Physical Performance Battery
Disability
Senior Housing
Aging
Lead sponsor: LeadingAge
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2009-01-06
Enrollment: 320
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short Physical Performance Battery score
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Falls that result in participant being completely on the ground
timeFrame: 12
measure: Incidence of hospitalization
timeFrame: 12 months
measure: Incidence of Nursing home admission
timeFrame: 12 months
measure: Incidence of emergence room visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Mountain Home
country: United States
facility: Good Samaritan Society - Mountain Home
state: Arkansas
city: Loveland
country: United States
facility: Good Samaritan Society - Loveland Village
state: Colorado
city: Deland
country: United States
facility: Good Samaritan Society - Florida Luthern
state: Florida
city: Kissimmee
country: United States
facility: Good Samaritan Society - Kissemmee Village
state: Florida
city: Olathe
country: United States
facility: Good Samaritan Society - Cedar Lake Village
state: Kansas
city: Waconia
country: United States
facility: Good Samaritan Society - Westview Acres
state: Minnesota
city: Hastings
country: United States
facility: Good Samaritan Society - Hastings Village
state: Nebraska
city: Albuquerque
country: United States
facility: Good Samaritan Society - Manzano del Sol
state: New Mexico
city: Gresham
country: United States
facility: Good Samaritan Society - Fairlawn Village
state: Oregon
city: Denton
country: United States
facility: Good Samaritan Society - Denton Village
state: Texas
Study officials:
affiliation: LeadingAge
name: Helaine Resnick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.