- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02350387
Efficacy of Eccentric Resistance Training in Persons With Knee Osteoarthritis
연구 개요
상태
정황
상세 설명
Arthritis is the leading cause of disability in the United States. Osteoarthritis (OA) is the most common type of arthritis and affects nearly 27 million Americans. Knee OA is the most common type of osteoarthritis and is estimated to affect 42.1% of women and 31.2% of men over the age of 60.
Osteoarthritis is most likely multi-factorial with several underlying causes. It is no longer considered "a degenerative joint disease" but rather a process that involves dynamic biomechanical, biochemical, and cellular processes. It not only involves degeneration of the articular cartilage, but also inflammation of the synovium, changes to the underlying subchondral bone, and the development of osteophytes. Currently, it appears that numerous systemic factors can lead to the initiation of OA through different causal pathways . These systemic causes can then be amplified by local factors such as trauma or increased loading caused by obesity.
Currently, there is no "cure" for OA and attempts to find a disease modifying drug have been unsuccessful. Thus, treatment currently focuses on mitigating factors that are known to affect the radiographic progression of the disease as well as lead to activity limitation and participation restriction.9,10 Decreases in lower extremity strength are a major cause of activity limitations given the vital role of strength in activities of daily living.
One method that is used to mitigate progressing factors is through the use of an exercise program. Many types of exercise have been used successfully in the literature including resistance training. Resistance training can take many different forms such as isometric, isotonic (concentric and/or eccentric) or isokinetic with various intensities. Presently, there is little evidence for the use of eccentric training interventions for patients with knee OA. This study aims to further examine this type of resistance training for the OA population. Therefore, the purpose of this study is to examine the effects of low intensity, long duration eccentric resistance training and high intensity, short duration eccentric resistance training in individuals with knee OA. Ideally, this study will allow us to determine the overall effects of eccentric resistance training as well as the potential differences of the two types of eccentric resistance training.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Colorado
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Denver, Colorado, 미국, 80221
- Regis University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Individuals will be included in the study if they are:
- at least 55 years old,
- cognitively able to understand directions,
- able to ambulate at least 50 feet without stopping,
- are currently experiencing knee pain and
- meet at least 3 out of 6 criteria of the European League Against Rheumatism (EULAR) criteria for knee osteoarthritis diagnosis.
Exclusion Criteria:
Individuals will be excluded from the study if they have:
- a diagnosed medical condition that would limit physical ability, including acute or active fractures, myocardial infarctions, stroke,
- a traumatic brain injury within the last 6 months, or
- joint replacement within the last 12 months. Individuals with chronic neurological disorders limiting motion or present with any known contraindication for balance training will also be excluded from the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: High Intensity Short Duration Exercise
Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
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Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
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실험적: Low Intensity Long Duration Exercise
Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.
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Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Isometric quadriceps strength as measured by a hand held dynamometer
기간: Change from baseline to 8 weeks
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The primary outcome for this study is the change in quadriceps strength from baseline to 8 weeks (end of intervention) in both experimental groups.
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Change from baseline to 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Lower extremity muscle strength as measured by a hand held dynamometer
기간: Change from baseline to 8 weeks
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Trunk flexion/extension, Hip Abduction/Extension, Knee Flexion/Extension, and Ankle Plantarflexion and Dorsiflexion will be assessed at baseline and 8 weeks by a hand held dynamometer.
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Change from baseline to 8 weeks
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Timed Up and Go Test
기간: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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6-minute Walk Test
기간: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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Five times sit to stand test
기간: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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Balance (assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test)
기간: Change from baseline to 8 weeks
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Balance will be assessed utilizing the romberg, sharpened romberg, one-legged stance test, functional reach test, and step test.
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Change from baseline to 8 weeks
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Arthritis Impact Measurement Scale (AIMS)
기간: Change from baseline to 8 weeks
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Change from baseline to 8 weeks
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Pain and muscle soreness ( assessed utilizing a numeric pain rating scale)
기간: At the beginning of every treatment session and following every treatment session for the 8 week intervention
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Pain and muscle soreness will be assessed utilizing a numeric pain rating scale at the beginning and end of every treatment session.
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At the beginning of every treatment session and following every treatment session for the 8 week intervention
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Michael J Bade, PT, PhD, Regis University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 15-010
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. .
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