Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients（EXCAVATION-CHN1）

April 23, 2017 updated by: Jun Tao, First Affiliated Hospital, Sun Yat-Sen University
The purpose of this study is to determine the effect of aerobic exercise training on microcirculation rarefaction in Chinese young male primary hypertensive patients stage 1. Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure elevated would not be diagnose in time until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However, cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with even primary hypertension stage 1. Exercise prescription is gathering great importance in preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch signaling plays an important role in vascular formation and maintenance. However, there is no prospective, randomized, controlled, clinic trial to investigate the effect of exercise on microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but also improve microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and then randomized in aerobic exercise intervention group and control group (only health education), the intervention will be carried out by Cycle Ergometer, the protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood flow and reactive hyperemia by venous occlusion plethysmography (FMD), PWV, central arterial pressure, RHI with Endopat, also the quantification of endothelial progenistor cells(EPCs) separated from peripheral blood.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hypertension is one of the most common world-wide chronic diseases, and it is showing a growing younger trend, which with mild blood pressure elevated would not be diagnose in time until blood pressure raises up or symptoms show up (Mild blood pressure indicates blood pressures ranging from 140 to 159 mmHg systolic and/or 90 to 99 mmHg diastolic). However, cumulative evidences prove that microvascular rarefaction exist in hypertensive patients with even primary hypertension stage 1. Exercise prescription is gathering great importance in preventive health. Aerobic exercise, especially, has the potential to diminish blood pressure values, and aerobic exercise can promote angiogenesis in coronary heart disease. Notch signaling plays an important role in vascular formation and maintenance. However, there is no prospective, randomized, controlled, clinic trial to investigate the effect of exercise on microcirculation rarefaction in hypertension. In summary, investigators propose a hypothesis that aerobic exercise might not only have a blood pressure lowing effect but also improve microcirculation rarefaction in Chinese male adults with primary mild hypertension. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise test (CPET) and then randomized in aerobic exercise intervention group and control group (only health education), the intervention will be carried out by Cycle Ergometer, the protocol consists of 3 sessions a day: 3 minutes Warm up, 45 minutes Resistance Exercise at 75% of HRmax; 10 minutes Recovery. Thus 58 minutes a day and 5 days a week (about 2000kcal) and 12 weeks in total. Prior and after all intervention sessions (12 weeks), nail fold capillary microscopy and retinal capillary Optical Coherence Tomography(OCT) angiography will be assessed, as well as 24h blood pressure monitoring, echocardiography, forearm blood Flow Mediated Diastolic function(FMD), Plus Wave Velocity(PWV), Reactive Hyperemia Index(RHI) with Endopat, also the quantification of endothelial progenistor cells(EPCs) separated from peripheral blood.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital,Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Jianwen Liang, PhD
        • Sub-Investigator:
          • Wenhao Xia, PhD

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

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subjects range from 18 to 40 years old.
  • male
  • Blood pressure is primary hypertension stage I(systolic blood pressure 140 to 159 mmHg and/or diastolic blood pressure 90 to 99 mmHg).
  • Able to participate in exercise
  • No regular physically active in the last 4 months
  • Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

  • Less than 18 years old or above 40 years old
  • Secondary hypertension.
  • Females
  • Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
  • Medical history of cardiovascular disease: acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular blockade, peripheral vascular disease or cerebrovascular accident
  • Patients who are unfavorable of long-term follow-up or poor compliance

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: Aerobic Exercise group
Cardio Pulmonary Exercise Test(CPET) Cycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks
Behavioral: Aerobic Exercise
Cycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks
Behavioral: Health Education
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol
Other: Health Education Group
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol Cardio Pulmonary Exercise Test(CPET) No Cycle ergometer exercise
Behavioral: Health Education
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT))
Time Frame: Change from Baseline retinal capillary density at 12 weeks
Change from Baseline retinal capillary density at 12 weeks
Nail fold capillary numbers per square millimeter( /mm²)
Time Frame: Change from Baseline nail fold capillary density at 12 weeks
Change from Baseline nail fold capillary density at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hours ambulatory blood pressure (ABP) in millimeters of mercury(mmHg)
Time Frame: Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure at 12 weeks
Change from Baseline Systolic Blood Pressure and Diastolic Blood Pressure at 12 weeks
Flow-mediated Dilation(FMD) in %
Time Frame: Change from Baseline percentage at 12 weeks
The percentage change in brachial artery diameter from baseline
Change from Baseline percentage at 12 weeks
Reactive Hyperemia Index(RHI) in the ratio of the average amplitude of the PAT signal
Time Frame: Change from Baseline ratio at 12 weeks
RHI was measured using the RH-PAT system (EndoPAT):A blood pressure cuff was placed on 1 upper arm with the contralateral arm serving as a control. A PAT probe was placed on 1 finger of each hand. After a 5-minute equilibration period, the cuff was inflated to 60 mm Hg above the systolic pressure or to 200 mm Hg for 5 minutes, then deflated to induce reactive hyperemia.
Change from Baseline ratio at 12 weeks
Abilities of tube formation of endothelial progenistor cells(EPCs) in tube numbers
Time Frame: Change from Baseline tube numbers at 12 weeks
Tube formation ability of EPCs was evaluated by counting tube numbers. Images of tube morphology were taken under the inverted phase contrast microscope.
Change from Baseline tube numbers at 12 weeks
Left Ventricular End-diastolic Volume (LVEDV) in milliliter(ml)
Time Frame: Change from Baseline volume at 12 weeks
Change from Baseline volume at 12 weeks

Collaborators and Investigators

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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Haipeng Xiao, PhD, First Affiliated Hospital, Sun Yat-Sen University

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

May 1, 2016

Primary Completion (Anticipated)

July 30, 2017

Study Completion (Anticipated)

July 30, 2017

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 26, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 23, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVD001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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 Primary Hypertension

Clinical Trials on Aerobic Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe