Staying Healthy Through Education and Prevention Study (STEP)
Early Screening and Exercise for Prevention of Disability in Persons Residing in Continuing Care Retirement Communities
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
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Arkansas
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Mountain Home、Arkansas、アメリカ、72653
- Good Samaritan Society - Mountain Home
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Colorado
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Loveland、Colorado、アメリカ、80537
- Good Samaritan Society - Loveland Village
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Florida
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Deland、Florida、アメリカ、32724
- Good Samaritan Society - Florida Luthern
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Kissimmee、Florida、アメリカ、34746
- Good Samaritan Society - Kissemmee Village
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Kansas
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Olathe、Kansas、アメリカ、66061
- Good Samaritan Society - Cedar Lake Village
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Minnesota
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Waconia、Minnesota、アメリカ、55387
- Good Samaritan Society - Westview Acres
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Nebraska
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Hastings、Nebraska、アメリカ、68901
- Good Samaritan Society - Hastings Village
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New Mexico
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Albuquerque、New Mexico、アメリカ、87108
- Good Samaritan Society - Manzano del Sol
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Oregon
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Gresham、Oregon、アメリカ、97030
- Good Samaritan Society - Fairlawn Village
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Texas
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Denton、Texas、アメリカ、76201
- Good Samaritan Society - Denton Village
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
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Physical Activity program
他の名前:
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アクティブコンパレータ: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.
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Wellness program
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Short Physical Performance Battery score
時間枠:12 months
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12 months
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Incidence of Falls that result in participant being completely on the ground
時間枠:12
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12
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Incidence of hospitalization
時間枠:12 months
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12 months
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Incidence of Nursing home admission
時間枠:12 months
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12 months
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Incidence of emergence room visit
時間枠:12 months
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12 months
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協力者と研究者
捜査官
- 主任研究者:Helaine Resnick, PhD、American Association of Homes and Services for the Aging
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HHSA290200600024
- 7581700 8-K72PS80 25505
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Physical Activityの臨床試験
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University of OttawaThe Ottawa Hospital; Queen's University; Consortium of Multiple Sclerosis Centers完了
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Centre Hospitalier Universitaire de Besancon募集
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University Hospital, Toulouse積極的、募集していない
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Saglik Bilimleri UniversitesiMedical Park Hospital Istanbul完了
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Istanbul University - Cerrahpasa (IUC)まだ募集していません