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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPET exercise prescription, 6MWT exercise prescription, Regular exercise.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 45 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Systolic blood pressure, SBP [Time frame: through study completion, an average of 1 year]
  • Diastolic blood pressure, DBP [Time frame: through study completion, an average of 1 year]
  • Heart rate, HR [Time frame: through study completion, an average of 1 year]
  • Pulse wave velocity, PWV [Time frame: through study completion, an average of 1 year]
  • PWV [Time frame: through study completion, an average of 1 year]
  • weight [Time frame: through study completion, an average of 1 year]
  • Body mass index, BMI [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (6)
  • Blood lipids [Time frame: through study completion, an average of 1 year]
  • exercise hypertension [Time frame: through study completion, an average of 1 year]
  • circadian rhythm of blood pressure [Time frame: through study completion, an average of 1 year]
  • anxiety [Time frame: through study completion, an average of 1 year]
  • depression [Time frame: through study completion, an average of 1 year]
  • use of antihypertensive drugs [Time frame: through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06219512 · RDL2022-23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗