Self-Directed Exercise Program for Adults With Arthritis
2021年4月26日 更新者:Sara Wilcox、University of South Carolina
Evaluation of a Self-directed, Packaged Physical Activity Program for Adults With Arthritis
The purpose of this study is to examine the effectiveness and safety of a self-directed physical activity program relative to a self-directed dietary program in adults with arthritis.
A process evaluation will also be conducted to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction.
調査の概要
詳細な説明
Physical activity is a critical component of arthritis disease management.
It also reduces the risk for other chronic comorbid conditions in people with arthritis.
Yet, most adults with arthritis are not sufficiently active at the level needed to achieve benefits.
Existing group-based arthritis exercise programs reach only a very small percentage of the population.
The overall purpose of this study is to test a self-directed and low-cost multicomponent physical activity program for people with arthritis on outcomes including symptoms of arthritis, lower body strength, functional aerobic capacity, flexibility, physical activity, arthritis self-efficacy and disability, upper body strength, balance, gait, and depressive symptoms.
The second primary aim is to evaluate the safety of the physical activity program.
The third primary aim is to conduct a process evaluation to examine program reach, participation/dose, fidelity, and participant compatibility/satisfaction.
Adults aged 18 years and older with arthritis will be recruited from the midlands area of South Carolina.
After completion of a baseline visit, participants will be randomized in equal numbers to the 12-week physical activity program (First Step to Active Health®) or the 12-week attention-control group (Steps to Healthy Eating).
The attention control intervention will have the same "look and feel" as the physical activity intervention and will require similar activities such as self-monitoring of behavior.
Follow-up measurements will take place post-program (12-weeks) and 6 months post-program (i.e., 9 months post-randomization).
If First Step to Active Health® is shown to be effective, it could be widely disseminated for a very low cost, thus having the potential to make a tremendous public health impact on the burden of arthritis.
研究の種類
介入
入学 (実際)
401
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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South Carolina
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Columbia、South Carolina、アメリカ、29208
- University of South Carolina Prevention Research Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Self-reported, health care provider-diagnosed arthritis (CDC definition)
- 18+ years of age
- Self-reported symptoms of joint pain, stiffness, tenderness, decreased range of motion, redness and warmth, deformity, crackling or grating, or fatigue
- Able to read and write in English
Exclusion Criteria:
- Another member of household is participating in study
- Plans to move from the Columbia, SC area in the next 9 months
- Unable to walk longer than 3 minutes without taking a rest
- Unable to stand without assistance for more than 2 minutes
- Cannot sit in a chair without arms for more than 5 minutes
- Measured resting blood pressure >160/100
- Positive response to PAR-Q question(s)
- Had a fall in the past year that required medical assistance
- Pregnant or breastfeeding
- Uses insulin to manage diabetes
- Participating in another research study that includes an intervention or drug
- Participates in 3+ days of structured moderate-intensity exercise for 30+ minutes per day
- Participates in 2+ days of strength building exercises for 20+ minutes per day
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:Multicomponent exercise
This arm is a self-directed, multicomponent, exercise intervention.
Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises.
Participants also complete a daily log of their exercises and return the logs every week for 12 weeks.
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This intervention is a self-directed, multicomponent, exercise intervention.
Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises.
Participants also complete a daily log of their exercises and return the logs every week for 12 weeks.
The active intervention phase is 12 weeks.
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アクティブコンパレータ:Nutrition
This arm is a self-directed nutrition intervention.
Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans.
Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks.
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This arm is a self-directed nutrition intervention.
Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans.
Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks.
The active intervention lasts for 12 weeks.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Symptoms of arthritis
時間枠:12 weeks
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Visual numeric scales to assess pain, fatigue, and stiffness
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12 weeks
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Lower body strength
時間枠:12 weeks
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The 30-second chair stand will assess lower body strength.
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12 weeks
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Functional exercise capacity
時間枠:12 weeks
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The six-minute walk will assess functional exercise capacity
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12 weeks
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Flexibility
時間枠:12 weeks
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The sit-and-reach test will assess flexibility
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12 weeks
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Physical activity
時間枠:12 weeks
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The Community Health Activities Model Program for Seniors Physical Activity (CHAMPS) Questionnaire will assess physical activity participation
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12 weeks
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Arthritis management self-efficacy
時間枠:12 weeks
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The Arthritis Self-Efficacy Scale will assess confidence in managing arthritis symptoms
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disability
時間枠:12 weeks
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The Health Assessment Questionnaire (HAQ) will assess disability
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12 weeks
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Upper body strength
時間枠:12 weeks
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The grip strength test (kg/lbs of force) will assess upper body strength
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12 weeks
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Balance
時間枠:12 weeks
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Postural sway will be measured with the AMTI force platform to determine COP displacement, COP velocity, and 95th eclipse
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12 weeks
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Gait
時間枠:12 weeks
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GAITRite will assess components of gait including cadence, step time, cycle time, step length, stride length, and velocity
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12 weeks
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Depressive symptoms
時間枠:12 weeks
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The short form of the Center for Epidemiological Studies Depression scale (CES-D) will assess depressive symptoms
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12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Sara Wilcox, PhD、University of South Carolina
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Baruth M, Wilcox S, Jake-Schoffman DE, Schlaff RA, Goldufsky TM. Effects of a Self-Directed Nutrition Intervention Among Adults With Chronic Health Conditions. Health Educ Behav. 2018 Feb;45(1):61-67. doi: 10.1177/1090198117709317. Epub 2017 Jun 3.
- Wilcox S, McClenaghan B, Sharpe PA, Baruth M, Hootman JM, Leith K, Dowda M. The steps to health randomized trial for arthritis: a self-directed exercise versus nutrition control program. Am J Prev Med. 2015 Jan;48(1):1-12. doi: 10.1016/j.amepre.2014.08.006. Epub 2014 Nov 6.
- Schoffman DE, Wilcox S, Baruth M. Association of body mass index with physical function and health-related quality of life in adults with arthritis. Arthritis. 2013;2013:190868. doi: 10.1155/2013/190868. Epub 2013 Dec 12.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年9月1日
一次修了 (実際)
2012年7月1日
研究の完了 (実際)
2012年7月1日
試験登録日
最初に提出
2010年5月17日
QC基準を満たした最初の提出物
2010年7月28日
最初の投稿 (見積もり)
2010年7月29日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月28日
QC基準を満たした最後の更新が送信されました
2021年4月26日
最終確認日
2021年4月1日
詳しくは
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。