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

NCT ID: NCT06219512

Last Updated: 2024-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPET exercise prescription group

Formulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT \[frequency, intensity, time and type\]

Group Type EXPERIMENTAL

CPET exercise prescription

Intervention Type BEHAVIORAL

Exercise mode: walk Frequency: 5 times/week

6MWT exercise prescription group

Exercise prescription is set according to the recommendation of the Chinese expert consensus on the application of clinical norms of six-minute walking test

Group Type EXPERIMENTAL

6MWT exercise prescription

Intervention Type BEHAVIORAL

Exercise mode: walk Frequency: 5 times/week

Regular exercise group

Carry out regular exercise as usual

Group Type ACTIVE_COMPARATOR

Regular exercise

Intervention Type BEHAVIORAL

Regular exercise

Interventions

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CPET exercise prescription

Exercise mode: walk Frequency: 5 times/week

Intervention Type BEHAVIORAL

6MWT exercise prescription

Exercise mode: walk Frequency: 5 times/week

Intervention Type BEHAVIORAL

Regular exercise

Regular exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Xi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yang Xi, Doctor

Role: STUDY_DIRECTOR

Peking University People's Hospital

Central Contacts

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Yang Xi, Doctor

Role: CONTACT

+86-10-88325552

References

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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.

Reference Type BACKGROUND
PMID: 32860412 (View on PubMed)

Other Identifiers

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RDL2022-23

Identifier Type: -

Identifier Source: org_study_id

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