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DisabilitySTEPNCT00817193

Staying Healthy Through Education and Prevention Study

A study testing Physical Activity and Wellness in people with Disability, run by LeadingAge at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Disability
What is being tested?
Physical Activity and Wellness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
10 sitesUnited States
Study dates
Jan 2009to Sep 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites
  • Good Samaritan Society - Manzano del Sol

    Albuquerque, New Mexico, 87108

  • Good Samaritan Society - Florida Luthern

    DeLand, Florida, 32724

  • Good Samaritan Society - Denton Village

    Denton, Texas, 76201

  • Good Samaritan Society - Fairlawn Village

    Gresham, Oregon, 97030

  • Good Samaritan Society - Hastings Village

    Hastings, Nebraska, 68901

  • Good Samaritan Society - Kissemmee Village

    Kissimmee, Florida, 34746

  • Good Samaritan Society - Loveland Village

    Loveland, Colorado, 80537

  • Good Samaritan Society - Mountain Home

    Mountain Home, Arkansas, 72653

  • Good Samaritan Society - Cedar Lake Village

    Olathe, Kansas, 66061

  • Good Samaritan Society - Westview Acres

    Waconia, Minnesota, 55387

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Disability
Being tested
Physical Activity, Wellness
Keywords
Clinical trial, Short Physical Performance Battery, Disability, Senior Housing, Aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical ActivityBehavioural

    Also called Exercise

    Physical Activity program

  • WellnessBehavioural

    Also called Active control

    Wellness program

Study groups in NCT00817193
Study groupRoleWhat they receive
Physical ActivityExperimentalParticipants 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.
Receives: Behavioral: Physical Activity
WellnessActive comparatorParticipants 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.
Receives: Behavioral: Wellness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Physical Performance Battery score

    Measured: 12 months

Secondary outcomes (4)
  1. Incidence of Falls that result in participant being completely on the ground

    Measured: 12

  2. Incidence of hospitalization

    Measured: 12 months

  3. Incidence of Nursing home admission

    Measured: 12 months

  4. Incidence of emergence room visit

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00817193
Sponsor's protocol ID
HHSA290200600024
Other IDs
7581700 8-K72PS80 25505
Acronym
STEP
Status last verified
Feb 2025
First submitted
5 Jan 2009
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No

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.

    PubMed 17167156

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity and Wellness in people with Disability, run by LeadingAge at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Physical Performance Battery score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00817193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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