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临床试验/NCT06219512
NCT06219512尚未招募不适用

Evaluation of the Clinical Effect of the Formulation of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)

Peking University People's Hospital0 个研究点目标入组 126 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
126
主要终点
PWV

研究概览

简要总结

Obesity and lack of exercise are one of the reasons for high blood pressure. Exercise can reduce the risk of cardiovascular events by reducing weight and blood pressure. The precise formulation of exercise prescription by cardiopulmonary exercise test (CPET) can effectively control hypertension. Our research group has formulated 50 "exercise prescriptions for hypertension population" in the early stage, but how to further effectively implement them needs to be discussed.

Based on the previous experience of undertaking the project "Exercise Prescription for Hypertensive People" of General Administration of Sport of the People's Republic of China, this research group discussed the important role of intelligent information management in the clinical effect evaluation and effective implementation of exercise prescription for hypertension; To explore the feasibility of making exercise prescription for hypertension based on 6-min walking test, and whether it is not inferior to or equivalent to the accuracy and effectiveness of making exercise prescription by CPET. The relevant results will lay a foundation for exploring the broader adaptation of hypertension exercise prescription to the population.

详细描述

The 6-minute walking test (6MWT) has good universality and accessibility, and can be used as the basis for formulating exercise prescriptions. According to the consensus of Chinese experts on the application of clinical norms of the six-minute walking test, it is recommended to formulate individualized exercise prescriptions based on the average walking speed of 6MWT calculated from the six-minute walking distance (6MWD), but there is no relevant content about hypertension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Overweight/obesity; Normal or normal high blood pressure after drug use; Grade 1 hypertension (whether taking medicine or not); Having sports habits; Sports risk is low and medium

排除标准

  • •≥ grade 2 Hypertension; High-risk hypertensive patients; Malignant hypertension, secondary hypertension, etc; Serious arrhythmia, heart failure, acute myocardial infarction; Severe stroke, liver and kidney insufficiency; Physical dysfunction and failure to cooperate for various reasons; Unable to conduct CPET; The Types and doses of antihypertensive drugs is still in the process of adjustment

研究组 & 干预措施

CPET exercise prescription group

Experimental

Formulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT [frequency, intensity, time and type]

干预措施: CPET exercise prescription (Behavioral)

6MWT exercise prescription group

Experimental

Exercise prescription is set according to the recommendation of the Chinese expert consensus on the application of clinical norms of six-minute walking test

干预措施: 6MWT exercise prescription (Behavioral)

Regular exercise group

Active Comparator

Carry out regular exercise as usual

干预措施: Regular exercise (Behavioral)

结局指标

主要结局

PWV

时间窗: through study completion, an average of 1 year

pulse wave velocity

weight

时间窗: through study completion, an average of 1 year

weight (kg)

Body mass index, BMI

时间窗: through study completion, an average of 1 year

body mass index (kg/m\^2)

Diastolic blood pressure, DBP

时间窗: through study completion, an average of 1 year

diastolic blood pressure (mmHg)

Heart rate, HR

时间窗: through study completion, an average of 1 year

Heart rate (beats/min)

Pulse wave velocity, PWV

时间窗: through study completion, an average of 1 year

pulse wave velocity

Systolic blood pressure, SBP

时间窗: through study completion, an average of 1 year

systolic blood pressure (mmHg)

次要结局

  • circadian rhythm of blood pressure(through study completion, an average of 1 year)
  • anxiety(through study completion, an average of 1 year)
  • Blood lipids(through study completion, an average of 1 year)
  • exercise hypertension(through study completion, an average of 1 year)
  • use of antihypertensive drugs(through study completion, an average of 1 year)
  • depression(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yang Xi

Doctor

Peking University People's Hospital

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