HypertensionNCT06219512
Clinical Effect of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
A study testing CPET exercise prescription, 6MWT exercise prescription and Regular exercise in people with Hypertension, run by Peking University People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Hypertension
- What is being tested?
- CPET exercise prescription, 6MWT exercise prescription and Regular exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- ≥ 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- CPET exercise prescription, 6MWT exercise prescription, Regular exercise
- Keywords
- hypertension, Exercise prescription, Intelligent information management, 6-min walking test (6MWT), Cardiopulmonary exercise test (CPET)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPET exercise prescriptionBehavioural
Exercise mode: walk Frequency: 5 times/week
6MWT exercise prescriptionBehavioural
Exercise mode: walk Frequency: 5 times/week
Regular exerciseBehavioural
Regular exercise
| Study group | Role | What they receive |
|---|---|---|
| CPET exercise prescription group | Experimental | Formulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT [frequency, intensity, time and type] Receives: Behavioral: CPET exercise prescription |
| 6MWT exercise prescription group | Experimental | Exercise prescription is set according to the recommendation of the Chinese expert consensus on the application of clinical norms of six-minute walking test Receives: Behavioral: 6MWT exercise prescription |
| Regular exercise group | Active comparator | Carry out regular exercise as usual Receives: Behavioral: Regular exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure, SBP
systolic blood pressure (mmHg)
Measured: through study completion, an average of 1 year
Diastolic blood pressure, DBP
diastolic blood pressure (mmHg)
Measured: through study completion, an average of 1 year
Heart rate, HR
Heart rate (beats/min)
Measured: through study completion, an average of 1 year
Pulse wave velocity, PWV
pulse wave velocity
Measured: through study completion, an average of 1 year
PWV
pulse wave velocity
Measured: through study completion, an average of 1 year
weight
weight (kg)
Measured: through study completion, an average of 1 year
Body mass index, BMI
body mass index （kg/m^2）
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Blood lipids
Triglyceride, total cholesterol, low-density lipoprotein cholesterol
Measured: through study completion, an average of 1 year
exercise hypertension
yes/no
Measured: through study completion, an average of 1 year
circadian rhythm of blood pressure
Ambulatory blood pressure monitoring
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
use of antihypertensive drugs
Record dosage and numbers of antihypertensive drugs using questionnaires.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xi, Peking University People's Hospital
- Investigators
- Yang Xi, Doctor, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219512
- Sponsor's protocol ID
- RDL2022-23
- Status last verified
- Jan 2024
- First submitted
- 22 Feb 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of patients in the maximum extent
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 disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.
PubMed 32860412
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Effect of the Formulation of Individualized Exercise Prescription for Hypertension With 6-minute Walking Test (6MWT)
- ClinicalTrials.gov ID
- NCT06219512
- Acronym / sponsor ID
- RDL2022-23
- Conditions
- Hypertension
- Keywords
- hypertension, Exercise prescription, Intelligent information management, 6-min walking test (6MWT), Cardiopulmonary exercise test (CPET)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPET exercise prescription group | Experimental | Behavioral: CPET exercise prescriptionFormulate exercise prescription of cardiopulmonary exercise test (CPET) according to the principle of FITT [frequency, intensity, time and type] |
| 6MWT exercise prescription group | Experimental | Behavioral: 6MWT exercise prescriptionExercise 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 comparator | Behavioral: Regular exerciseCarry out regular exercise as usual |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- ≥ 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPET exercise prescriptionExercise mode: walk Frequency: 5 times/week | Behavioural | CPET exercise prescription group |
| 6MWT exercise prescriptionExercise mode: walk Frequency: 5 times/week | Behavioural | 6MWT exercise prescription group |
| Regular exerciseRegular exercise | Behavioural | Regular exercise group |
Primary outcome
Systolic blood pressure, SBP
Time frame: through study completion, an average of 1 year
systolic blood pressure (mmHg)
Diastolic blood pressure, DBP
Time frame: through study completion, an average of 1 year
diastolic blood pressure (mmHg)
Heart rate, HR
Time frame: through study completion, an average of 1 year
Heart rate (beats/min)
Pulse wave velocity, PWV
Time frame: 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
weight
Time frame: through study completion, an average of 1 year
weight (kg)
Body mass index, BMI
Time frame: through study completion, an average of 1 year
body mass index （kg/m^2）
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 32860412Pelliccia 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.
- Individual participant dataSharing planned: No. To protect the privacy of patients in the maximum extent
Related trials for Hypertension
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 2
Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma
Pheochromocytoma, Paraganglioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yang Xi, Doctor study director
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CPET exercise prescription, 6MWT exercise prescription and Regular exercise in people with Hypertension, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Xi, Doctor (+86-10-88325552, yangxi1016@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure, SBP (time frame: through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06219512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.