Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients(EXCAVATION-CHN1)
Primary Purpose
Primary Hypertension
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Aerobic Exercise
Health Education
Sponsored by
About this trial
This is an interventional treatment trial for Primary Hypertension
Eligibility 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
Sites / Locations
- First Affiliated Hospital,Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Aerobic Exercise group
Health Education Group
Arm Description
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
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol Cardio Pulmonary Exercise Test(CPET) No Cycle ergometer exercise
Outcomes
Primary Outcome Measures
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT))
Nail fold capillary numbers per square millimeter( /mm²)
Secondary Outcome Measures
24 hours ambulatory blood pressure (ABP) in millimeters of mercury(mmHg)
Flow-mediated Dilation(FMD) in %
The percentage change in brachial artery diameter from baseline
Reactive Hyperemia Index(RHI) in the ratio of the average amplitude of the PAT signal
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.
Abilities of tube formation of endothelial progenistor cells(EPCs) in tube numbers
Tube formation ability of EPCs was evaluated by counting tube numbers. Images of tube morphology were taken under the inverted phase contrast microscope.
Left Ventricular End-diastolic Volume (LVEDV) in milliliter(ml)
Full Information
NCT ID
NCT02817204
First Posted
June 22, 2016
Last Updated
April 23, 2017
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02817204
Brief Title
Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients(EXCAVATION-CHN1)
Official Title
Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients(EXCAVATION-CHN1)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 30, 2017 (Anticipated)
Study Completion Date
July 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic Exercise group
Arm Type
Experimental
Arm Description
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
Arm Title
Health Education Group
Arm Type
Other
Arm Description
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol Cardio Pulmonary Exercise Test(CPET) No Cycle ergometer exercise
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol
Primary Outcome Measure Information:
Title
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT))
Time Frame
Change from Baseline retinal capillary density at 12 weeks
Title
Nail fold capillary numbers per square millimeter( /mm²)
Time Frame
Change from Baseline nail fold capillary density at 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
Flow-mediated Dilation(FMD) in %
Description
The percentage change in brachial artery diameter from baseline
Time Frame
Change from Baseline percentage at 12 weeks
Title
Reactive Hyperemia Index(RHI) in the ratio of the average amplitude of the PAT signal
Description
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.
Time Frame
Change from Baseline ratio at 12 weeks
Title
Abilities of tube formation of endothelial progenistor cells(EPCs) in tube numbers
Description
Tube formation ability of EPCs was evaluated by counting tube numbers. Images of tube morphology were taken under the inverted phase contrast microscope.
Time Frame
Change from Baseline tube numbers at 12 weeks
Title
Left Ventricular End-diastolic Volume (LVEDV) in milliliter(ml)
Time Frame
Change from Baseline volume at 12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Tao, PhD
Phone
+8613922191609
Email
taojungz123@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haipeng Xiao, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Tao, PhD
Phone
+8613922191609
Email
taojungz123@163.com
First Name & Middle Initial & Last Name & Degree
Jianwen Liang, PhD
First Name & Middle Initial & Last Name & Degree
Wenhao Xia, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31718666
Citation
Liang J, Li Y, Chen L, Xia W, Wu G, Tong X, Su C, He J, Lin X, Tao J. Systemic microvascular rarefaction is correlated with dysfunction of late endothelial progenitor cells in mild hypertension: a substudy of EXCAVATION-CHN1. J Transl Med. 2019 Nov 12;17(1):368. doi: 10.1186/s12967-019-2108-8. Erratum In: J Transl Med. 2020 Jan 16;18(1):26.
Results Reference
derived
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Effect of Aerobic EXercise on MiCroVAscular RarefacTION in Chinese Mild HyperteNsive Patients(EXCAVATION-CHN1)
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