- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03450655
Cardio Training of Older Adults With Central Obesity
연구 개요
상세 설명
Central obesity means having a lot visceral fat, that is, fat located in the abdominal cavity. Visceral fat is a well-established risk factor for cardiovascular disease and all-cause mortality.
Participants will be recruited from the Healthy Ageing Initiative (HAI), an ongoing population-based study that invites all 70-year-olds in Umeå, Sweden, to a health examination. The exercise program will focus is on station-based aerobic exercises and resistance exercises, predominantly with participants' own body weight as resistance. The program is progressive, starting at a moderate pace so that participants learn to perform the exercises properly. The intensity will be aimed at 60-80% of maximal exhaustion, and each exercise bout will last 60 seconds with 20 seconds of rest between bouts. The program was developed by seniors in the bachelor's program in exercise physiology at Umeå University, Sweden.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Västerbotten
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Umeå, Västerbotten, 스웨덴, 907 36
- Livsmedicin (LIFE)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participated in the Healthy Ageing Initiative (a population-based intervention study in Umeå, Sweden)
- Visceral adipose tissue mass >1 kg (women) or >2 kg (men)
Exclusion Criteria:
- Physical disability that affects ability to perform the exercises
- Heart failure or severe degenerative condition (e.g. malignant cancer or multiple sclerosis)
- Myocardial infarction or stroke in the past year
- Heart condition that can worsen with aerobic exercise (e.g. angina)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Intervention Group
Weeks 1-10: exercise program in group.
Weeks 11-20: no intervention.
Weeks 21-31: no intervention.
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An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
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실험적: Control group
Weeks 1-10: no intervention.
Weeks 11-20: no intervention.
Weeks 21-31: exercise program at home.
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An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in visceral adipose tissue mass
기간: 0, 10, 20, and 31 weeks
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Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).
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0, 10, 20, and 31 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in body composition
기간: 0, 10, 20, and 31 weeks
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Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA)
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0, 10, 20, and 31 weeks
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Change in Body Mass Index (kg/m^2)
기간: 0, 10, 20, and 31 weeks
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0, 10, 20, and 31 weeks
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Change in blood pressure (mmHg)
기간: 0, 10, 20, and 31 weeks
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Taken after 15 min of rest
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0, 10, 20, and 31 weeks
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Change in blood-lipid profile
기간: 0, 10, 20, and 31 weeks
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0, 10, 20, and 31 weeks
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Change in fasting blood glucose
기간: 0, 10, 20, and 31 weeks
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Veinous blood samples taken after > 4 h of fasting
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0, 10, 20, and 31 weeks
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Change in isometric muscle strength
기간: 0, 10, 20, and 31 weeks
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Measured in non-dominant hand with dynamometer (Jamar, Lafayette Instrument, USA).
The better of two successive trials will be recorded.
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0, 10, 20, and 31 weeks
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Change in physical capacity
기간: 0, 10, 20, and 31 weeks
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Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle
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0, 10, 20, and 31 weeks
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Change in resting metabolic rate
기간: 0, 10, 20, and 31 weeks
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As measured by indirect calorimetry
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0, 10, 20, and 31 weeks
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Change in health-related quality of life
기간: 0, 10, 20, and 31 weeks
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As measured by RAND-36
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0, 10, 20, and 31 weeks
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Change in self-reported physical activity
기간: 0, 10, 20, and 31 weeks
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Assessed using IPAQ-SF
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0, 10, 20, and 31 weeks
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Change in Microbiota composition
기간: 0, 10, 20, and 31 weeks
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Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition
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0, 10, 20, and 31 weeks
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Change in dietary habits
기간: 0, 10, 20, and 31 weeks
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85 item food frequency questionnaire
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0, 10, 20, and 31 weeks
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Change in concentration of inflammatory markers
기간: 0, 10, 20, and 31 weeks
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0, 10, 20, and 31 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Ballin M, Hult A, Bjork S, Lundberg E, Nordstrom P, Nordstrom A. Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial. BMC Geriatr. 2020 May 12;20(1):173. doi: 10.1186/s12877-020-01577-w.
- Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of interval training on quality of life and cardiometabolic risk markers in older adults: a randomized controlled trial. Clin Interv Aging. 2019 Sep 4;14:1589-1599. doi: 10.2147/CIA.S213133. eCollection 2019.
- Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70-Year-Old Individuals: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1625-1631. doi: 10.1111/jgs.15919. Epub 2019 Apr 23.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .