- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03978975
Water Exercise and Health (WATHEALTH) (WATHEALTH)
Effect of Water Temperature on Energy Response During Aquatic Cycling in Women: Impact of Weight Status
연구 개요
상세 설명
After inclusion visit, all subject will be submitted to DXA to obtain body composition data. Then subjects will be submitted to four experimental session in a semi-randomized order. For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
Control session (CON): subject will stand sited without any activity during 40 min.
Subjects will be submitted to three aquatic cycling exercise session:
- session 27°C :aquatic cycling at 27°C without water jet during 40 min
- session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min
- session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Clermont-Ferrand, 프랑스, 63000
- 모병
- CHU clermont-ferrand
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연락하다:
- Lise Laclautre
- 이메일: drci@chu-clermontferrand.fr
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women aged between 20 and 40 years
- BMI under 25kg.m2 for normal weight women and between 25 and 29,9 kg.m2 for overweight women
- Daily breakfast
- Subject which approved informed consent
- Subject with French medical affiliation
Exclusion Criteria:
- Specific medical treatment
- Aquaphobia
- Subject under specific diet regimen or weight loss program
- Subject with cardio-vascular disease
- Surgical intervention less than 3 months
- Subject refusing informed and written consent
- Subject without French medical affiliation
- subject refusing inscription to the national voluntary list
- subject being in an exclusion period
- subject smoking or drinking alcohol frequently
- subject with intense physical activity
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: normal weight women
20 women with a body mass index ranging between 18,5 and 24,9 kg.m2
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For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session:
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실험적: overweight women
20 women with a body mass index ranging between 25 and 29,9 kg.m2
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For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session. Control session (CON): subject will stand sited without any activity during 40 min. Subjects will be submitted to three aquatic cycling exercise session:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Food intake during buffet meal 30 minutes after the end of experimental session
기간: Day 7
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 7
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Food intake during buffet meal 30 minutes after the end of experimental session
기간: Day 14
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 14
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Food intake during buffet meal 30 minutes after the end of experimental session
기간: Day 21
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 21
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Food intake during buffet meal 30 minutes after the end of experimental session
기간: Day 28
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total energy intake at the post session lunch will be calculated by measuring food intake
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Day 28
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Appetite, hunger and satiety
기간: Day 7
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 7
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Appetite, hunger and satiety
기간: Day 14
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 14
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Appetite, hunger and satiety
기간: Day 21
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 21
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Appetite, hunger and satiety
기간: Day 28
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using a visual analog scale from 0 millimeter (no sensation) to 100mm (highest sensation)
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Day 28
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Energy expenditure
기간: Day 7
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with a gas analyser energy expenditure will be measured in kcal
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Day 7
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Energy expenditure
기간: Day 14
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with a gas analyser energy expenditure will be measured in kcal
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Day 14
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Energy expenditure
기간: Day 21
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with a gas analyser energy expenditure will be measured in kcal
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Day 21
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Energy expenditure
기간: Day 28
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with a gas analyser energy expenditure will be measured in kcal
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Day 28
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Perceived exertion
기간: Day 7
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 7
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Perceived exertion
기간: Day 14
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 14
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Perceived exertion
기간: Day 21
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 21
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Perceived exertion
기간: Day 28
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using Borg scale perceived exertion will be evaluated between 6 (very light) and 20 (extremely difficult)
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Day 28
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공동 작업자 및 조사자
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. .