- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01250444
Effects of Inspiratory Muscle Training on Cardiovascular Function in Hypertension. (TREMVEN)
Inspiratory Muscle Training: Effects on Blood Pressure, Heart Rate Variability and Functional Capacity in Hypertensive Patients.
연구 개요
상태
개입 / 치료
상세 설명
The interaction between respiratory function and cardiovascular system, as well as the present alterations in these systems, due to diseases such as Hypertension, diabetes and chronic heart failure, are the factors that potentially participate of the pathogenic frame in these situations. Consequently, it is so related to reduction of functional capacity, endothelial dysfunction of the sympathetic and parasympathetic cardiovascular control and morphologic alterations on the skeletal muscles, including ventilatory muscles.
On the other hand, a proinflammatory state also participates of this dysfunction and reduced function capacity situation. Cardiovascular risk factors, such as hypertension, increased heart rate variability, diabetes and heart failure explain the occurrence of the majority of cardiovascular events in the entire world and so in Brazil. Studies with experimental models and in patients with cardiovascular diseases identified important inflammatory activity associated to risk factors and preceding clinical events.
Inspiratory muscle training (IMT) shows consistent results in the improvement of functional capacity in athletes, sedentary subjects, heart failure patients and in animals submitted to an IMT model.
The study of alterations in cardiorespiratory interaction, functional capacity and cardiovascular control mechanisms (sympathetic, parasympathetic by heart rate variability), altogether, in hypertension, is a single opportunity to identify new pathogenic mechanisms involved in the reduction of functional capacity as well as promote its quantification. Therefore, the effects of IMT on these alterations are still not well understood. In this way, the response to IMT is a complement to epidemiologic and clinical models, as potential source of new possibilities in the research field.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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RS
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Porto Alegre, RS, 브라질, 90050-170
- Pedro Dal Lago
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age between 25 and 70
- Hypertension in all stages:
2.1. Prehypertension - Systolic blood pressure (SBP) of 120 to 139 and/or diastolic blood pressure (DBP) of 80 to 89 mmHg 2.2.Stage 1 Hypertension - SBP of 140 to 159 mmHg and/or DBP of 90 to 99 mmHg 2.3.Stage 2 Hypertension - SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg
Exclusion Criteria:
- Disagreement with consent form
- Thoracic pain (angina)
- Hypertension instability
- Antihypertensive drugs alterations within 30 days before or during the study
- Diabetes
- Chronic pulmonary obstructive disease
- Incapability of executing the functional tests
- Asthma
- Chronic Heart Failure
- Obesity
- Cardiovascular diseases complications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Inspiratory Muscle Training
It will me performed a loaded training of ventilatory muscles in patients with Hypertension.
Its is done with the practice of breathing exercises associated to an training device, specific for this kind of intervention.
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Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Differences on blood pressure levels
기간: eight weeks
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Blood pressure behavior is accessed by Ambulatory Blood Pressure Monitorying.
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eight weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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improvement of Heart rate variability
기간: eight weeks
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eight weeks
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improvement of quality of life
기간: eigth weeks
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To measure the quality of life, it is used the SF36 short form questionary.
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eigth weeks
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Improvement of Functional Capacity
기간: eight weeks
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It is measure by the oxytgen consumption accessed by ergospirometry.
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eight weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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. .
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