NCT05528068

Brief Summary

Hypertension is a major risk factor for cardiovascular disease and cardiovascular events. Healthy lifestyle factors are widely recommended for hypertension prevention and control, and cardiorespiratory fitness is a strong and independent predictor of the progression of hypertension. Increased cardiorespiratory fitness through lifestyle modifications is associated with lower mortality in hypertensive or high-normal blood pressure individuals. The aim of the study is to evaluate the effects of supervised lifestyle intervention that include diet and exercise and base on intelligent application and continuous physiological monitoring on improvement of cardiopulmonary fitness, blood pressure and other health outcomes among participants with hypertension or high-normal blood pressure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
424

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

July 27, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2023

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

August 25, 2022

Last Update Submit

September 2, 2022

Conditions

HypertensionHigh-normal Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Change in peak oxygen uptake (VO2peak) from baseline to 3 months

    VO2peak is obtained by a graded cardiopulmonary exercise test to assess cardiorespiratory fitness, which is measured at baseline, 3 months.

    baseline, 3 months

Secondary Outcomes (20)

  • Change in systolic blood pressure

    baseline, 3 months, 6 months and 9 months

  • Change in diastolic blood pressure

    baseline, 3 months, 6 months and 9 months

  • Change in cardiopulmonary exercise test-derived anaerobic threshold (AT)

    baseline, 3 months and 9 months

  • Change in cardiopulmonary exercise test-derived oxygen uptake efficiency slope (OUES)

    baseline, 3 months and 9 months

  • Change in cardiopulmonary exercise test-derived peak respiratory exchange ratio (RERpeak)

    baseline, 3 months and 9 months

  • +15 more secondary outcomes

Study Arms (2)

control group

PLACEBO COMPARATOR

standard care, physiological monitoring by wearable devices and healthy lifestyle education

Behavioral: healthy lifestyle education

supervised lifestyle intervention group

EXPERIMENTAL

standard care, physiological monitoring by wearable devices and personalized and supervised lifestyle intervention including dietary and physical activity modification

Behavioral: supervised lifestyle intervention

Interventions

supervised lifestyle interventionBEHAVIORAL

Participants will receive personalized dietary and exercise prescription according to the assessment of nutritional status, physical fitness and physiological-biochemical indexes. The participants will use the digital application for the first 3 months with supervised lifestyle intervention. Wearable devices, such as ambulatory blood pressure monitoring, dynamic electrocardio scanner and smart watch, will be worn to provide continuous physiological monitoring for safety. And then, participants will use the application by self-management for the next 6 months. All participants are given questionnaires, nutritional, physical fitness and physiological-biochemical assessment at baseline, 3 months, 6 months and 9 months.

supervised lifestyle intervention group
healthy lifestyle educationBEHAVIORAL

Participants will receive standard care and healthy lifestyle education for hypertension prevention and control. Wearable devices, such as ambulatory blood pressure monitoring, dynamic electrocardio scanner and smart watch, will be worn to provide continuous physiological monitoring for safety. Participants will use the application by self-management for 9 months. All participants are given questionnaires, nutritional, physical fitness and physiological-biochemical assessment at baseline, 3 months, 6 months and 9 months.

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • who is ≥18 years old and \< 70 years old;
  • hypertension or high-normal blood pressure;
  • who has a smart phone and can use it (android phones are preferred).

You may not qualify if:

  • with acute myocardial infarction, acute tachyarrhythmia, pulmonary edema, severe aortic stenosis and other serious circulatory diseases or respiratory diseases;
  • with acute cardiovascular and cerebrovascular diseases;
  • poor blood pressure control;
  • with physical limitations(e.g., restricting injuries of the musculoskeletal system, such as fractures, unstable joints and other physical diseases);
  • with skin disease or skin damage at the site of wearable device;
  • with mental disorder, epilepsy or other diseases resulting in inability to control the body;
  • pacemaker installation;
  • woman who is during pregnancy or prepare for pregnancy;
  • sensitive skin for wearable devices; 10）refuse to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Xue Feng, MD PhD

    Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongyi Du, MD PhD

CONTACT

86-10-88396087duhy@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Deputy Director

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 6, 2022

Study Start

July 27, 2022

Primary Completion

April 27, 2023

Study Completion

October 27, 2023

Last Updated

September 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

to contact the researcher for sharing after the trial

Locations

CN(1)