- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01172327
Self-Directed Exercise Program for Adults With Arthritis
2021년 4월 26일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
401
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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South Carolina
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Columbia, South Carolina, 미국, 29208
- University of South Carolina Prevention Research Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Symptoms of arthritis
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disability
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Sara Wilcox, PhD, University of South Carolina
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 9월 1일
기본 완료 (실제)
2012년 7월 1일
연구 완료 (실제)
2012년 7월 1일
연구 등록 날짜
최초 제출
2010년 5월 17일
QC 기준을 충족하는 최초 제출
2010년 7월 28일
처음 게시됨 (추정)
2010년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 26일
마지막으로 확인됨
2021년 4월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .