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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219512
• Other study ID #: RDL2022-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Peking University People's Hospital
• Contact: Yang Xi, Doctor
• Phone: +86-10-88325552
• Email: yangxi1016[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & 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. Erratum In: Eur Heart J. 2021 Feb 1;42(5):548-549. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure, SBP	systolic blood pressure (mmHg)	through study completion, an average of 1 year
Primary	Diastolic blood pressure, DBP	diastolic blood pressure (mmHg)	through study completion, an average of 1 year
Primary	Heart rate, HR	Heart rate (beats/min)	through study completion, an average of 1 year
Primary	Pulse wave velocity, PWV	pulse wave velocity	through study completion, an average of 1 year
Primary	PWV	pulse wave velocity	through study completion, an average of 1 year
Primary	weight	weight (kg)	through study completion, an average of 1 year
Primary	Body mass index, BMI	body mass index (kg/m^2)	through study completion, an average of 1 year
Secondary	Blood lipids	Triglyceride, total cholesterol, low-density lipoprotein cholesterol	through study completion, an average of 1 year
Secondary	exercise hypertension	yes/no	through study completion, an average of 1 year
Secondary	circadian rhythm of blood pressure	Ambulatory blood pressure monitoring	through study completion, an average of 1 year
Secondary	anxiety	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.	through study completion, an average of 1 year
Secondary	depression	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.	through study completion, an average of 1 year
Secondary	use of antihypertensive drugs	Record dosage and numbers of antihypertensive drugs using questionnaires.	through study completion, an average of 1 year