- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00005555
Dose Response to Exercise and Cardiovascular Health
연구 개요
상세 설명
BACKGROUND:
Results from the study will provide important data regarding the dose of exercise required to improve cardiovascular health, as described both by the NIH Consensus Conference on Physical Activity and CV Health and by the recent Report of the Surgeon General. The study was initiated in response to a Program Announcement released in October 1994 on Physical Activity and Cardiopulmonary Health.
DESIGN NARRATIVE:
Subjects were randomized into one of five groups in a 2x2 factorial design plus a usual care control group (n=100 in each of 5 groups). Subjects trained at a moderate (45-55 percent) or high (65-75 percent of maximum heart rate reserve) intensity, and at a frequency of 3-4 or 5-7 days/week (viz., Group 1, 65-75 percent at 5-7 days/week; Group 2, 65-75 percent at 3-4 days/week; Group 3, 45-55 percent at 5-7 days/weekk; Group 4, 45-55 percent at 3-4 days/week; and, Group 5, usual care control). Controls received advice from a physician to increase their physical activity. The subjects in Groups 1-4 participated in an exercise intervention using walking as the mode of training for a total of 24 months. A lifestyle model of physical activity was used, in that subjects could accumulate exercise minutes during the day in 10-minute increments or more continuously (for a total duration of 30 minutes/day), and training was conducted where it was most convenient for the subject (i.e. at home, work or some combination thereof). Tests occurred at baseline (0), 12, and 24 months of the intervention.
The hypothesis was that Groups 1-4 would show a significant reduction in systolic and diastolic blood pressure and an increase in HDL-cholesterol compared to the usual care control group. A second hypothesis was that that there would be significant main effects for both frequency and intensity, with the higher levels of each producing greater improvement on the major outcome variables compared to the lower levels of each dose. The study also planned to determine the minimal dose response to exercise necessary to elicit significant improvement in cardiovascular and behavioral health factors. Finally, the project included examination of the effects of age and level of initial test values on outcome variables to determine if their interactions affected the results of the intervention.
The study also includes assessment of the effect of specific doses of exercise on the reduction in systolic and diastolic blood pressure and increase in HDL-cholesterol (primary outcomes), in addition to changes in levels of physical activity, aerobic fitness (VO2 max), body composition (percent fat and waist-to-hip ratio), triglycerides, and LDL-cholesterol (secondary outcomes). Psychological variables (depression, anxiety, anger, and perceived stress) and health-related quality of life are also evaluated, and the important issue of adherence to exercise is examined with respect to the effect of dose of exercise.
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
공동 작업자 및 조사자
수사관
- Michael Perri, University of Florida
간행물 및 유용한 링크
일반 간행물
- Perri MG, Anton SD, Durning PE, Ketterson TU, Sydeman SJ, Berlant NE, Kanasky WF Jr, Newton RL Jr, Limacher MC, Martin AD. Adherence to exercise prescriptions: effects of prescribing moderate versus higher levels of intensity and frequency. Health Psychol. 2002 Sep;21(5):452-8.
- Duncan GE, Perri MG, Theriaque DW, Hutson AD, Eckel RH, Stacpoole PW. Exercise training, without weight loss, increases insulin sensitivity and postheparin plasma lipase activity in previously sedentary adults. Diabetes Care. 2003 Mar;26(3):557-62. doi: 10.2337/diacare.26.3.557.
- Duncan GE, Sydeman SJ, Perri MG, Limacher MC, Martin AD. Can sedentary adults accurately recall the intensity of their physical activity? Prev Med. 2001 Jul;33(1):18-26. doi: 10.1006/pmed.2001.0847.
- Duncan GE, Anton SD, Newton RL Jr, Perri MG. Comparison of perceived health to physiological measures of health in Black and White women. Prev Med. 2003 May;36(5):624-8. doi: 10.1016/s0091-7435(03)00017-3.
- Duncan GE, Perri MG, Anton SD, Limacher MC, Martin AD, Lowenthal DT, Arning E, Bottiglieri T, Stacpoole PW. Effects of exercise on emerging and traditional cardiovascular risk factors. Prev Med. 2004 Nov;39(5):894-902. doi: 10.1016/j.ypmed.2004.03.012.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
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. .