- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01910935
Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
연구 개요
상세 설명
Secondary Hypothesis:
The intervention achieved a significant change in the group of hypertensive patients in the following variables:
- Decreased levels of systolic and diastolic blood pressure, biochemical markers such as total cholesterol, triglycerides and fasting blood glucose and increased HDL cholesterol.
- Increase muscular endurance and cardio-respiratory capacity according to the categories of risk stratification.
- Decreased body weight, body mass index and waist circumference.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Morelos
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Cuernavaca, Morelos, 멕시코, 62000
- Instituto Mexicano del Seguro Social. Morelos. HGR/MF. No, UMF 3, UMF 20, UMF 23
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diagnosed with high blood pressure <5 years of evolution and / or without use of drug therapy to treat that condition;
- with low levels of physical activity (PA) or physically inactive (less than 150 minutes of PA at week, intensity moderate to vigorous);
- with availability to PA practice or considering begin to PA practice within the next six months (contemplation or preparation stages of the Transtheoretical Model).
- Without cardiovascular risk (assessed previously);
- Without physical or mobility problems that impede PA practice;
- Willingness to participate in the study, fulfill with outlined activities to develop the proposal.
Exclusion Criteria:
- high-risk patients according to the risk stratification of the American College of Sports Medicine;
- fulfill the high recommendation of physical activity (more than 300 minutes per week of moderate to vigorous intensity);
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Physical activity prescription
24 weeks physical activity program. 1 hour, 3 times a week, moderate to vigorous intensity.
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Overall the intervention involves a medical reference in primary care (PHC) to hypertensive patients (during routine consultation) to assist the sports facilities of the same Institute, to develop a group program of physical activity which will last 24 weeks.
Led by the trained staff in physical activity to patients with chronic diseases.
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간섭 없음: No physical activity prescription
Provide information to patients about the benefits of physical activity and how to increase it safely.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Physical activity. Level of physical activity between intervention and control groups.
기간: 24 weeks
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The length of the intervention is 24 weeks, the control group will be followed for 24 weeks also. The outcome measure is a composite at three moments of the study. Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention. The intervention will be effective if the difference in the percent of population (complying the minimum recommended of physical activity) among control and intervention groups is at least of 20%. |
24 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Blood pressure
기간: 24 weeks
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Blood pressure among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks.
The outcome measure is a composite at three moments of the study.
Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.
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24 weeks
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Composite measure of biochemical markers: total cholesterol, triglycerides and fasting blood glucose
기간: 24 weeks
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Biochemical markers (total cholesterol, triglycerides and fasting blood glucose) among intervention and control groups, at the three moments of the study: basal measurement, 24 weeks (end of the intervention) and 36 weeks.
The secondary outcome measure is a composite at three moments of the study.
Basal measurement, 24 weeks and 36 weeks, this last moment to assess sustainability of the intervention.
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24 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Gallegos-Carrillo Katia, D. Sc, Instituto Mexicano del Seguro Social/Unidad de Investigación Epidemiologica y en Servicios de Salud.
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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. .