- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03531034
Ambulatory and Blood Pressure Variability Responses to Exercise in Normotensive and Hypertensive Women
2021년 1월 7일 업데이트: Igor Moraes Mariano, Federal University of Uberlandia
Ambulatory and Blood Pressure Variability Responses to Combined Exercise in Normotensive and Hypertensive Menopausal Women
This study evaluated the differences between normotensive and hypertensive menopausal women in ambulatory and blood pressure variability responses to combined aerobic and resistance exercise.
연구 개요
상세 설명
The differences in hypotensive and cardioprotective responses of exercise among menopausal hypertensive and normotensive women are still not very clear, mainly the responses of blood pressure variability.
In this way, were evaluated 6 indices related to the variability of 24 hour ambulatory pressure measurements in these women before and after 12 weeks of combined exercise training.
연구 유형
중재적
등록 (실제)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Minas Gerais
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Uberlandia, Minas Gerais, 브라질, 38400-678
- Guilherme Morais Puga
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
Inclusion Criteria:
- amenorrhea for at least 12 months; body mass index ≤30 kg/m2; ability to engage in treadmill and resistance exercises; hypertension nom-medicated with beta-blockers
Exclusion Criteria:
- history of diabetes, cancer or cardiovascular disease (except for hypertension in Hypertensive group); doing hormone therapy or soy derived supplementation; smokers
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Hypertensive Women
Group of hypertensive and controlled women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities.
In addition this group could not modify the dose or type of the medicine and should be using the same medicine and dose for at least 6 months
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The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks.
Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise.
The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups.
The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities.
After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
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활성 비교기: Normotensive Women
Group of normotensive women who practiced 10 weeks of training with Combined Exercise Training, non-obese, nonsmokers and with no characteristics that prevented them from performing the activities.
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The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks.
Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise.
The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups.
The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities.
After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Changes in Ambulatorial Blood Pressure
기간: Before and within 72 hours after 10 weeks of exercise training
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All volunteers were submitted to a 24-hour Blood Pressure (BP) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) before and after 10 weeks of combined exercise training, with a minimum of 48 hours after the last training session.
A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements.
The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h.
The monitoring was considered valid when it happened for a period of 24 hours.
The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods.
Before the use ABPM during daily activities, resting blood pressure were measured using the same equipment after 15 min of rest in siting position.
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Before and within 72 hours after 10 weeks of exercise training
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Ambulatorial Blood Pressure Variability
기간: Before and within 72 hours after 10 weeks of exercise training
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Based on Ambulatorial Blood Pressure data, were calculated Blood Pressure Variability by: 24-hour standard deviation weighted by the time interval between consecutive readings; the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval; the average real variability weighted for the time interval between consecutive readings; the ambulatory arterial stiffness index calculated by the slope of the trend curve of the dispersion of pressure data; the morning surge that represents the dynamic daytime variation in morning pressure that tends to increase, being assessed from the point of least pressure during sleep in relation to the first two hours after waking; and nocturnal dipping, that represents the average percentage drop of sleep pressure in relation to wakefulness, and individuals with falls of 10% or more are considered dippers and below that are considered nom-dippers.
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Before and within 72 hours after 10 weeks of exercise training
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Changes in Heart Rate Variability
기간: Before and within 72 hours after 10 weeks of exercise training
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Heart Rate (HR) was recorded using a heart rate monitor in a beat-by-beat basis.
HR was registered in a seat position for 20 min of rest.
Prior to the HR Variability (HRV) analysis, the RR intervals (RRi) were visually inspected and filtered using a moving average filter.
The HRV was analyzed in both time-, frequency- and nonlinear-domain.
Being that for frequency-domain analysis, firstly the RRi series were interpolated at 4 Hz and then the signal linear trend component removal was performed using the smooth priors approach.
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Before and within 72 hours after 10 weeks of exercise training
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Changes in salivary oxidative stress
기간: Before and within 72 hours after 10 weeks of exercise training
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The salivary was collected after 12-hours fasting and the total antioxidant capacity was evaluated using the Ferric-Ability of Plasma (FRAP) methodology and calculated from the standard trolox curve.
The activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol and catalase activity (CAT) by monitoring the consumption of hydrogen peroxide at 240 nm.
Lipid peroxidation levels were determined by the TBARS method (thiobarbituric acid reactive substances), using as standard a curve of 1,1,3,3-tetraethoxypropane (TMP).
The total protein concentration was obtained by the Bradford method (BRADFORD, 1976), using bovine serum albumin (BSA) as standard.
The amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method.
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Before and within 72 hours after 10 weeks of exercise training
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Guilherme M Puga, Dr, Federal University of Uberlândia
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 3월 1일
기본 완료 (실제)
2015년 12월 25일
연구 완료 (실제)
2016년 12월 25일
연구 등록 날짜
최초 제출
2018년 4월 17일
QC 기준을 충족하는 최초 제출
2018년 5월 8일
처음 게시됨 (실제)
2018년 5월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 7일
마지막으로 확인됨
2021년 1월 1일
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. .