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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое CPET exercise prescription
  Exercise mode: walk Frequency: 5 times/week
• Поведенческое 6MWT exercise prescription
  Exercise mode: walk Frequency: 5 times/week
• Поведенческое Regular exercise
  Regular exercise

Первичные конечные точки

• Systolic blood pressure, SBP [Срок оценки: through study completion, an average of 1 year]
• Diastolic blood pressure, DBP [Срок оценки: through study completion, an average of 1 year]
• Heart rate, HR [Срок оценки: through study completion, an average of 1 year]
• Pulse wave velocity, PWV [Срок оценки: through study completion, an average of 1 year]
• PWV [Срок оценки: through study completion, an average of 1 year]
• weight [Срок оценки: through study completion, an average of 1 year]
• Body mass index, BMI [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (6)

• Blood lipids [Срок оценки: through study completion, an average of 1 year]
• exercise hypertension [Срок оценки: through study completion, an average of 1 year]
• circadian rhythm of blood pressure [Срок оценки: through study completion, an average of 1 year]
• anxiety [Срок оценки: through study completion, an average of 1 year]
• depression [Срок оценки: through study completion, an average of 1 year]
• use of antihypertensive drugs [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• ≥ 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular dis PMID 32860412

Идентификаторы

NCT: NCT06219512 · RDL2022-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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