Clinical trial NCT06219512: Clinical Effect of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
Official title: Evaluation of the Clinical Effect of the Formulation of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
Exercise prescription
Intelligent information management
6-min walking test (6MWT)
Cardiopulmonary exercise test (CPET)
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 126
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* ≥ 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

Primary outcomes:
measure: Systolic blood pressure, SBP
timeFrame: through study completion, an average of 1 year
measure: Diastolic blood pressure, DBP
timeFrame: through study completion, an average of 1 year
measure: Heart rate, HR
timeFrame: through study completion, an average of 1 year
measure: Pulse wave velocity, PWV
timeFrame: through study completion, an average of 1 year
measure: PWV
timeFrame: through study completion, an average of 1 year
measure: weight
timeFrame: through study completion, an average of 1 year
measure: Body mass index, BMI
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Blood lipids
timeFrame: through study completion, an average of 1 year
measure: exercise hypertension
timeFrame: through study completion, an average of 1 year
measure: circadian rhythm of blood pressure
timeFrame: through study completion, an average of 1 year
measure: anxiety
timeFrame: through study completion, an average of 1 year
measure: depression
timeFrame: through study completion, an average of 1 year
measure: use of antihypertensive drugs
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Yang Xi, Doctor
role: STUDY_DIRECTOR
References:
citation: 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 disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.