Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA)
2022년 10월 10일 업데이트: Brian Focht, Ohio State University
The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA
The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.
연구 개요
상세 설명
Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks.
Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients.
Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients.
Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.
연구 유형
중재적
등록 (실제)
227
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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Ohio
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Columbus, Ohio, 미국, 43210
- The Ohio State University
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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
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
- Overweight or Obese: BMI >25 and <40
- Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
- Sedentary: sedentary lifestyle defined as currently participating < 20 minutes of weekly structured moderate intensity exercise occurring in bouts >10 min
- Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
- Age: > 50 years of age
- Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
- Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
- Agreeableness: willing to accept randomization and complete all assessment and intervention procedures
Exclusion Criteria:
- Health Status: any serious medical condition that precludes safe participation in an exercise program
- Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Exercise and Dietary Weight Loss
For the first 6 months, participants will meet at a community center for 3 group-based sessions and 1 individual session each month.
Sessions include a 45 minute exercise component and a 45 minute dietary weight loss component.
Exercise will consist of progressive aerobic and strength training.
The dietary component will focus on decreasing caloric intake, while being nutritionally safe.
All diets will be monitored by a Registered Dietitian.
During months 7-12, participants will meet for 1 group session and 1 individual session per month.
The final 12-24 months, bimonthly phone calls are provided to the participants to aid in retention efforts.
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The EX+DWL intervention consists of group and individual exercise sessions, as well as, nutritional and dietary counseling.
Bimonthly phone calls are made in the final year of the study to aid in maintenance of the program.
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활성 비교기: Walk with Ease
The Arthritis Foundation's (AF) WWE is a self-management program for symptoms of arthritis (pain, fatigue, stiffness,etc.) through exercise.
It is a 6 week program involving 3 sessions per week each lasting about 60 minutes.
The WWE sessions are comprised of walking, stretching and strengthening exercises, and health education lectures.
These group classes will be lead by an AF instructor.
Each participant will complete 2 consecutive WWE classes for a total of 12 weeks in the program.
During the final week of the program, participants will be trained and transitioin to the self-directed version of WWE for maintenance of exercise.
To aid in retention efforts, phone contacts are provided to participants on a monthly basis from 4-12 months and bi-monthly from 12 to 24 months
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The WWE 6 week program consists of health education lectures on arthritis self-management, a walking exercise portion, and at- home strength exercises.
Participants will complete two consecutive WWE programs.
Monthly and bimonthly phone calls are made to participants in months 4-12 and 12-24, respectively, to aid in maintenance of the program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mobility Disability
기간: baseline up to 2 years
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This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)
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baseline up to 2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Anthropometric Battery
기간: baseline up to 2 years
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Body weight and height are used to calculate Body Mass Index (BMI).
Body composition will be assessed using DEXA scans.
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baseline up to 2 years
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Functional Battery and Limitations
기간: baseline up to 2 years
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Stair-climb time (SCT) is a functional performance measure that involves ascending and descending a flight of 5 stairs as quickly as possible.
Limitations will be assessed using the Pepper Assessment Tool for Disability.
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baseline up to 2 years
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
기간: baseline up to two years
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Scale of 0 (none) to 4 (extreme) indicating the amount of difficulty they have experienced performing basic physical function tasks in the past 48 hours due to knee OA.
The physical function subscale consists of 17 items that will be summed to produce a physical function score.
Higher scores indicating poorer function
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baseline up to two years
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Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)
기간: baseline up to two years
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Health related quality of life survey consisting of mental and physical health with subscales of physical functioning, mental health, role-physical, role-emotional, bodily pain, general health, vitality, and social functioning
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baseline up to two years
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Dietary intake
기간: baseline up to two years
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Dietary intake will be assessed by a registered dietician using the Daily food record measure.
One weekend and 2 weekdays will be assessed.
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baseline up to two years
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Social Cognitive Process Measures
기간: baseline up to two years
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Physical activity barriers self-efficacy scale, Satisfaction with function and appearance scale, Multiple exercise self-regulatory self-efficacy scale, the weight efficacy lifestyle questionnaire (WEL), goal commitment and goal difficulty, arthritis self-efficacy, and pain acceptance.
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baseline up to two years
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Change in physical activity
기간: baseline up to two years
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Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer
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baseline up to two years
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Cost effectiveness
기간: baseline up to two years
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The cost-effectiveness of the EX+DWL intervention compared to the WWE [program will be calculated as the ratio of additional cost per participant per increment of effectiveness.
Effectiveness is based on improvement in the 400 MWT and the Quality of Well-being Scale- Self Administered (to calculate the Quality Adjusted Life Years).
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baseline up to two years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Brian Focht, PhD, Ohio State University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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
2016년 10월 1일
기본 완료 (실제)
2022년 4월 1일
연구 완료 (실제)
2022년 4월 1일
연구 등록 날짜
최초 제출
2016년 7월 13일
QC 기준을 충족하는 최초 제출
2016년 7월 13일
처음 게시됨 (추정)
2016년 7월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 10월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 10월 10일
마지막으로 확인됨
2022년 10월 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. .
Exercise and Dietary Weight Loss에 대한 임상 시험
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University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for... 그리고 다른 협력자들완전한