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

January 12, 2024 updated by: Yang Xi, Peking University People's Hospital

Evaluation of the Clinical Effect of the Formulation 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPET exercise prescription group
Formulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT [frequency, intensity, time and type]
Behavioral: CPET exercise prescription
Exercise mode: walk Frequency: 5 times/week
Experimental: 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
Behavioral: 6MWT exercise prescription
Exercise mode: walk Frequency: 5 times/week
Active Comparator: Regular exercise group
Carry out regular exercise as usual
Behavioral: Regular exercise
Regular exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure, SBP
Time Frame: through study completion, an average of 1 year
systolic blood pressure (mmHg)
through study completion, an average of 1 year
Diastolic blood pressure, DBP
Time Frame: through study completion, an average of 1 year
diastolic blood pressure (mmHg)
through study completion, an average of 1 year
Heart rate, HR
Time Frame: through study completion, an average of 1 year
Heart rate (beats/min)
through study completion, an average of 1 year
Pulse wave velocity, PWV
Time Frame: through study completion, an average of 1 year
pulse wave velocity
through study completion, an average of 1 year
PWV
Time Frame: through study completion, an average of 1 year
pulse wave velocity
through study completion, an average of 1 year
weight
Time Frame: through study completion, an average of 1 year
weight (kg)
through study completion, an average of 1 year
Body mass index, BMI
Time Frame: through study completion, an average of 1 year
body mass index （kg/m^2）
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipids
Time Frame: through study completion, an average of 1 year
Triglyceride, total cholesterol, low-density lipoprotein cholesterol
through study completion, an average of 1 year
exercise hypertension
Time Frame: through study completion, an average of 1 year
yes/no
through study completion, an average of 1 year
circadian rhythm of blood pressure
Time Frame: through study completion, an average of 1 year
Ambulatory blood pressure monitoring
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year
use of antihypertensive drugs
Time Frame: through study completion, an average of 1 year
Record dosage and numbers of antihypertensive drugs using questionnaires.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Study Director: Yang Xi, Doctor, Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDL2022-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of patients in the maximum extent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on CPET exercise prescription

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe