A Phase 3 interventional study of Aerobic Exercise and Health Education in Primary Hypertension, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to male participants aged 25 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Phase 3, Interventional, and Treatment
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.
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.
527 studies on the registry are indexed under Essential Hypertension; 76 are open to participants now.
This study's planned enrollment of 40 is below the median of 166 across 449 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: Health Education
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
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
Retinal capillary density with Quantitative Optical Coherence Tomography(OCT) angiography(OCT))
Time frame: 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
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
Flow-mediated Dilation(FMD) in %
The percentage change in brachial artery diameter from baseline
Time frame: Change from Baseline percentage at 12 weeks
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.
Time frame: Change from Baseline ratio at 12 weeks
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.
Time frame: 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
Plan to share: No
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First Affiliated Hospital, Sun Yat-Sen University