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NCT Number: NCT06219512

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPET exercise prescription

Behavioral

Exercise mode: walk Frequency: 5 times/week

6MWT exercise prescription

Behavioral

Exercise mode: walk Frequency: 5 times/week

Regular exercise

Behavioral

Regular exercise

Primary outcomes

  1. Systolic blood pressure, SBP

    Time frame: through study completion, an average of 1 year

    systolic blood pressure (mmHg)

  2. Diastolic blood pressure, DBP

    Time frame: through study completion, an average of 1 year

    diastolic blood pressure (mmHg)

  3. Heart rate, HR

    Time frame: through study completion, an average of 1 year

    Heart rate (beats/min)

  4. Pulse wave velocity, PWV

    Time frame: through study completion, an average of 1 year

    pulse wave velocity

  5. PWV

    Time frame: through study completion, an average of 1 year

    pulse wave velocity

  6. weight

    Time frame: through study completion, an average of 1 year

    weight (kg)

  7. Body mass index, BMI

    Time frame: through study completion, an average of 1 year

    body mass index （kg/m^2）

Secondary outcomes

  1. Blood lipids

    Time frame: through study completion, an average of 1 year

    Triglyceride, total cholesterol, low-density lipoprotein cholesterol

  2. exercise hypertension

    Time frame: through study completion, an average of 1 year

    yes/no

  3. circadian rhythm of blood pressure

    Time frame: through study completion, an average of 1 year

    Ambulatory blood pressure monitoring

  4. anxiety

    Time frame: 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.

  5. depression

    Time frame: 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.

  6. use of antihypertensive drugs

    Time frame: through study completion, an average of 1 year

    Record dosage and numbers of antihypertensive drugs using questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Xi, Doctor

CONTACT

[email protected]

+86-10-88325552

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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