Resistance Exercise for the Prevention of Age-related Sarcopenia (REPAiRS)
Negative Work Exercise as a Novel Treatment for Sarcopenia in Older Men
연구 개요
상세 설명
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20422
- VA Medical Center, DC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Adult, ambulatory males > 60 years old (n=30) will be recruited for this proposed study. Participant inclusion criteria also includes having clinically significant sarcopenia based on the body composition assessment showing an aLM that is < 2 SD below the mean values of a young adult reference group using DEXA scanning.
Exclusion Criteria:
Exclusion criteria include BMI scores > 30 or a Mini-Mental Status exam score of < 22. The second tier of screening will include the following blood tests, obtained between 8-9 AM, following a 12-hour overnight fast: CBC, routine chemistry profile (e.g., glucose, kidney and liver function tests). Veterans with an elevated fasting blood glucose by WHO criteria (FBG >110 mg/dl), triglyceride levels > 200 mg/dL, and/or known DM, or abnormalities of other routine blood tests (i.e., > 2 SD beyond normal) will be excluded from the study. Uncontrolled cardiovascular disease, non-ambulatory status, evidence of a major disease exacerbation over the last six months, and current participation in a supervised exercise program (minimum of three months, twice per week) would also preclude participation in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
Exercise group 1: Negative work exercise
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Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks.
Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
다른 이름들:
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다른: 2
Exercise group 2: Negative work exercise (delayed start for single-arm crossover trial)
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Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks.
Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in insulin sensitivity following the exercise intervention as estimated with the QUICKI algorithm (quantitative insulin sensitivity check index)
기간: Change from baseline in QUICKI values at week 6, week 12, and week 24
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Blood tests will be obtained after a 12- hour overnight fast at baseline, weeks 6, week 12 and week 24: glucose and insulin values will be determined before and during a standard (75 g) 2 hour oral glucose tolerance test (to determine insulin sensitivity via QUICKI algorithm.
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Change from baseline in QUICKI values at week 6, week 12, and week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Peak isokinetic torque
기간: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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Isokinetic knee and shoulder extension torques will be obtained bilaterally using the Biodex System 3
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Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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Diagnostic ultrasongraphy
기간: Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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Muscle thickness, pennation angle, and area at the flexor digitorum superficialis, lower-trapezius, rectus femoris and tibialis anterior (dominant side only).
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Treatment weeks: 1, 6, and 12; post-treatment weeks: 6 and 12
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공동 작업자 및 조사자
수사관
- 수석 연구원: Michael Harris-Love, DSc MPT BS, VA Medical Center, DC
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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 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. .