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

Not Applicable

Not yet recruiting

• Conditions: Hypertension
• Interventions: Behavioral: 6MWT exercise prescription; Behavioral: Regular exercise; Behavioral: CPET exercise prescription

• Registration Number: NCT06219512
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2023-02-22
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Study Start: 2024-02-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6MWT exercise prescription group	6MWT exercise prescription	Exercise prescription is set according to the recommendation of the Chinese expert consensus on the application of clinical norms of six-minute walking test
Regular exercise group	Regular exercise	Carry out regular exercise as usual
CPET exercise prescription group	CPET exercise prescription	Formulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT \[frequency, intensity, time and type\]

Primary Outcome Measures

Name	Time	Method
Body mass index, BMI	through study completion, an average of 1 year	body mass index （kg/m\^2）
weight	through study completion, an average of 1 year	weight (kg)
Pulse wave velocity, PWV	through study completion, an average of 1 year	pulse wave velocity
PWV	through study completion, an average of 1 year	pulse wave velocity
Diastolic blood pressure, DBP	through study completion, an average of 1 year	diastolic blood pressure (mmHg)
Heart rate, HR	through study completion, an average of 1 year	Heart rate (beats/min)
Systolic blood pressure, SBP	through study completion, an average of 1 year	systolic blood pressure (mmHg)

Secondary Outcome Measures

Name	Time	Method
circadian rhythm of blood pressure	through study completion, an average of 1 year	Ambulatory blood pressure monitoring
anxiety	through study completion, an average of 1 year	Anxiety score using Generalized Anxiety Disorder (GAD-7). High GAD-7 scores significantly predicted worse state of anxiety: no anxiety,0-4 scores; mild anxiety,5-9 scores; moderate anxiety,10-14 scores; severe anxiety,15-21 scores.
Blood lipids	through study completion, an average of 1 year	Triglyceride, total cholesterol, low-density lipoprotein cholesterol
exercise hypertension	through study completion, an average of 1 year	yes/no
use of antihypertensive drugs	through study completion, an average of 1 year	Record dosage and numbers of antihypertensive drugs using questionnaires.
depression	through study completion, an average of 1 year	Depression score using Patient Health Questionnaire-9 (PHQ-9). High PHQ-9 scores significantly predicted worse state of depression: no depression,0-4 scores; mild depression,5-9 scores; moderate depression,10-14 scores; severe depression,15-27 scores.