Effects of Anti-Hypertensive Acupuncture Treatment on Cerebral Blood Flow Responses to Exercise in Hypertensive Humans
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cerebrovascular Conductance Index
研究概览
简要总结
Cerebrovascular diseases (CVD) and neurodegenerative diseases (NDD) are both leading causes of death in the United States. Epidemiological data have shown that increased prevalence of hypertension is related to these outcomes. However, despite the strong association of poor brain health outcomes in patients with hypertension (HTN), the understanding of cerebral blood flow (CBF) regulation and treatment options for HTN remain limited. Acupuncture treatment (AT), which is considered a promising complementary and integrative modality, has been known to reduce blood pressure and improve endothelial function in HTN. However, very few studies have investigated AT's effect on cerebrovascular function and the possible neuroprotective properties directly via regulating HTN. Exercise is used as a stimulus that increases the brain's metabolism and requires cerebrovascular responses (vasodilation) to meet the new metabolism.
Therefore, the specific aim of this study is to test the hypothesis that an antihypertensive acupuncture treatment can acutely improve cerebrovascular responses in hypertensive humans during moderate exercise.
详细描述
After IRB approval, experiments will take place in the Human Circulation Research Laboratory in the Department of Health and Exercise on the OU Norman campus. All subjects will complete a total of 3 visits. The first is a screening visit to provide informed consent and to ensure the potential participant meets all inclusion criteria and no exclusion criteria. Once enrolled, participants will complete two experimental trials (Placebo (PL, Sham Acupuncture) or Real Acupuncture (RA), randomized) in a single-blinded crossover design. PL or RA treatment will precede testing by ~25min before to maximize acute responses. Test begins with 5 min of quiet rest where baseline measurements are taken, followed by 5 min of exercise. After exercise, subjects will be given 5 min of quiet rest.
Visit 1 (Screening day): ~1.5 hours. The screening visit will include informed consent, health history, physical activity questionnaires and blood sample. If qualified, the subject will be enrolled in the study and they will complete a maximal oxygen uptake (VO2max) cycle ergometer test to determine fitness.
Visit 2 & 3 (Study day): ~1.5 hours. Instrumentation: Subjects will be equipped with ECG for heart rate (HR), photoplethysmography for blood pressure, pulse oximeter, mouthpiece for end-tidal CO2 (PETCO2) and oxygen uptake (VO2), near-infrared spectroscopy (NIRS) for active muscle oxygenation and Transcranial Doppler (TCD) for CBF. Real Acupuncture (RA): Subjects will receive ~20 minutes of RA treatment prior to exercise. Placebo (PL): Specially designed Sham Acupuncture needles will be used in the same acupoints, for the same duration as RA.
All subjects will complete a total of 3 visits separated by a minimum of 48 hours. Each study visit will take ~1.5 hours. The investigators anticipate ~ 6 hours or less of total involvement of the participants' time.
This study is a single-blind crossover design. Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning the type of acupuncture devices. Outcome assessors and statisticians may not be blinded to treatment allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
This study is a single-blind crossover design. Participants will be blinded in two trials. Practitioners and operators will not be allowed to communicate with the participants concerning the type of acupuncture devices. Outcome assessors and statisticians may not be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will include healthy controls (CON) and Hypertension (HTN) patients between 18-65 years of age. Female participants if premenopausal will be studied in the early follicular phase of their cycle to minimize vascular effects of circulating hormones.
- •Stage 1 hypertensive, Systolic BP (SBP) ≥ 130 mmHg and/or Diastolic BP (DBP) > 80 mmHg, and/or diagnosis of HTN, with BMI and physical activity levels ≈ CON
- •If they are on anti-hypertensive medication, the dose, type, and frequency of use will be recorded.
- •HTN with an SBP > 139 mmHg must have a medical doctor's permission to participate
- •CON: will be age, BMI, menstrual status for females, and physical activity matched to HTN. They must be:
- •Normotensive
- •Free of cardiovascular comorbidities.
排除标准
- •Coronary artery disease
- •Heart attack
- •Sleep apnea
- •Tobacco use
- •Currently receiving antihypertensive acupuncture treatment
- •conditions where acupuncture might not be safe, such as metal allergy or needle-phobia. If a subject experiences severe acupuncture-associated response, it will be subject to early termination of the study.
结局指标
主要结局
Cerebrovascular Conductance Index
时间窗: 5 min of moderate exercise
Middle Cerebral Artery Blood Velocity relative to Mean Arterial Pressure (MCABV/MAP)
Middle cerebral artery blood velocity
时间窗: 5 min of moderate exercise
Velocity of blood through the middle cerebral arteries
Mean Arterial Pressure
时间窗: 5 min of moderate exercise
Integral of blood pressure waveform
次要结局
- blood high density lipoprotein levels(prior to enrollment)
- peripheral capillary oxygen saturation(5 min of moderate exercise)
- Oxygen Uptake(5 min of moderate exercise)
- blood glucose levels(prior to enrollment)
- blood triglyceride levels(prior to enrollment)
- blood low density lipoprotein levels(prior to enrolment)
- Tissue saturation index(5 min of moderate exercise)
- End-tidal CO2(5 min of moderate exercise)
- Heart Rate Variability(before and after acupuncture)