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

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ClinicalTrials.gov Identifier: NCT02817204
Recruitment Status : Unknown
Verified April 2017 by Jun Tao, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jun Tao, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Hypertension Behavioral: Aerobic Exercise Behavioral: Health Education Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients(EXCAVATION-CHN1)
Study Start Date : May 2016
Estimated Primary Completion Date : July 30, 2017
Estimated Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine


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

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




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

Secondary Outcome Measures :
  1. 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 ]
  2. Flow-mediated Dilation(FMD) in % [ Time Frame: Change from Baseline percentage at 12 weeks ]
    The percentage change in brachial artery diameter from baseline

  3. 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.

  4. 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.

  5. Left Ventricular End-diastolic Volume (LVEDV) in milliliter(ml) [ Time Frame: Change from Baseline volume at 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817204


Contacts
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Contact: Jun Tao, PhD +8613922191609 taojungz123@163.com

Locations
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China, Guangdong
First Affiliated Hospital,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jun Tao, PhD    +8613922191609    taojungz123@163.com   
Principal Investigator: Jianwen Liang, PhD         
Sub-Investigator: Wenhao Xia, PhD         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Haipeng Xiao, PhD First Affiliated Hospital, Sun Yat-Sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jun Tao, Professor,PhD, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02817204    
Other Study ID Numbers: HVD001
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Essential Hypertension
Microvascular Rarefaction
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical