Clinical Effect of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
Evaluation of the Clinical Effect of the Formulation of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
1 other identifier
interventional
126
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Feb 2024
Typical duration for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 23, 2024
January 1, 2024
2.9 years
February 22, 2023
January 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Systolic blood pressure, SBP
systolic blood pressure (mmHg)
through study completion, an average of 1 year
Diastolic blood pressure, DBP
diastolic blood pressure (mmHg)
through study completion, an average of 1 year
Heart rate, HR
Heart rate (beats/min)
through study completion, an average of 1 year
Pulse wave velocity, PWV
pulse wave velocity
through study completion, an average of 1 year
PWV
pulse wave velocity
through study completion, an average of 1 year
weight
weight (kg)
through study completion, an average of 1 year
Body mass index, BMI
body mass index （kg/m\^2）
through study completion, an average of 1 year
Secondary Outcomes (6)
Blood lipids
through study completion, an average of 1 year
exercise hypertension
through study completion, an average of 1 year
circadian rhythm of blood pressure
through study completion, an average of 1 year
anxiety
through study completion, an average of 1 year
depression
through study completion, an average of 1 year
- +1 more secondary outcomes
Study Arms (3)
CPET exercise prescription group
EXPERIMENTALFormulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT \[frequency, intensity, time and type\]
6MWT exercise prescription group
EXPERIMENTALExercise 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
ACTIVE COMPARATORCarry out regular exercise as usual
Interventions
Exercise mode: walk Frequency: 5 times/week
Exercise mode: walk Frequency: 5 times/week
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- ≥ 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 32860412BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yang Xi, Doctor
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
February 22, 2023
First Posted
January 23, 2024
Study Start
February 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 23, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share
To protect the privacy of patients in the maximum extent