Effect of Combined Transcutaneous Electrical Stimulation and Isometric Exercise on Peripheral Hemodynamic Parameters in Patients With Resistant Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pulse Pressure
研究概览
简要总结
The goal of this clinical trial is to learn if the combination between transcutaneous electrical nerve stimulation (TENS) and isometric exercise (IE) can improve blood pressure in men and women between 50 to 60 years old suffered from resistant hypertension which is a type of hypertension where blood pressure remains above your target goal despite the use of three or more different classes of antihypertensive medications at their maximum tolerated doses. The main question to answer is:
Is there a significant effect on the combined use of TENS and IE on peripheral hemodynamic parameters in patients with resistant hypertension? Total sample will be 50 patients from both sexes
I will compare between two groups:
Experimental group (15 men, 10 women) will take: medication plus IE and TENS Control group (15 men, 10 women) will take: medication plus Conventional Physical Therapy Program
详细描述
- Study Rationale: Resistant hypertension (RH) remains a significant clinical challenge, often requiring four or more medications to achieve blood pressure control. Chronic sympathetic overactivity is a hallmark of RH. (TENS) has shown promise in modulating autonomic tone, while IE is known to improve endothelial function and vascular resistance. However, the combined effect of these two non-pharmacological interventions on peripheral hemodynamics in RH patients has not been fully explored.
- Objectives: The primary objective of this study is to investigate the effect of a combined program of TENS and IE on peripheral hemodynamic parameters, including (Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Pulse Pressure (PP) and Heart Rate Variability (HRV) in patients diagnosed with RH.
- Study Design and Procedures: 50 Participants from both sexes will be randomly assigned using closed envelop to either the Experimental Group (Combined Intervention) or the Control Group (Conventional physical therapy program)
- Experimental group TENS protocol It will be used to stimulate the cervicothoracic sympathetic outflow (C7-T4), which contributes to the modulation of sympathetic activity, a key factor in the pathophysiology and management of resistant hypertension (RH) Electrode placements: bilaterally over the Paraspinal muscles at the T1-T5 levels (upper thoracic region), targeting sympathetic outflow to the cardiovascular system.
-Frequency: 2-10 Hz (low frequency stimulation)
-Pulse duration: 200 microseconds
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study follows a single-blind design. While the participants and the physical therapist providing the treatment are aware of the group allocation due to the nature of the interventions (isometric exercise and TENS), the outcomes assessor will remain blinded. This individual, responsible for measuring peripheral hemodynamic parameters at baseline and post-intervention, will not have access to the randomization list or the participants' group assignments. Additionally, the data analyst will be blinded by using coded identifiers for the groups during statistical analysis.
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 60 years. Both sexes were included Patients had been diagnosed with hypertension for at least 5 years.
- •Patients had resistant hypertension according to (Whelton et al 2018), defined as:
- •Systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg despite the use of three or more antihypertensive medications of different classes, including a diuretic,
- •or controlled blood pressure (<140/90 mmHg) while on four or more antihypertensive medications.
- •Body Mass Index (BMI) 25: 34.9 kg/m²
- •Increased waist circumference, defined as:
- •Greater than 102 cm for males.
- •Greater than 88 cm for females.
排除标准
- •Secondary hypertension due to identifiable causes (e.g., renal artery stenosis, primary aldosteronism, pheochromocytoma).
- •History of major cardiovascular events in the last 6 months (e.g., myocardial infarction, stroke, or heart failure exacerbation).
- •Severe musculoskeletal or neurological disorders that impair the ability to perform isometric exercise safely (e.g., recent joint replacement, severe osteoarthritis, stroke with residual motor deficit).
- •Contraindications to the use of Transcutaneous Electrical Nerve Stimulation (TENS):
- •Implanted electronic devices: pacemakers, cardioverter defibrillators. Uncontrolled arrhythmias. Sever skin condition: open wounds, rashes, burns, eczema. Peripheral neuropathy or sensory loss.
- •Known cognitive impairment or psychiatric conditions that would limit the ability to follow instructions or provide informed consent.
研究组 & 干预措施
Combined TENS and Isometric Exercise
Participants in this arm will receive a combined intervention of Transcutaneous Electrical Nerve Stimulation (TENS) and a structured protocol of isometric exercises specifically designed for patients with resistant hypertension.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
Combined TENS and Isometric Exercise
Participants in this arm will receive a combined intervention of Transcutaneous Electrical Nerve Stimulation (TENS) and a structured protocol of isometric exercises specifically designed for patients with resistant hypertension.
干预措施: Isometric Exercise (Behavioral)
Conventional Physical Therapy Program
Participants in this arm will receive a standard conventional physical therapy program. This serves as the active control to compare the effectiveness of the combined TENS and exercise protocol against current standard practice.
干预措施: Aerobic, Dynamic Resistance, stretch and Breathing Exercises and Lifestyle Modification Advices (Behavioral)
结局指标
主要结局
Pulse Pressure
时间窗: 8 weeks
Definition and Calculation: Pulse Pressure (PP) is the primary hemodynamic outcome, representing the pulsatile component of the blood pressure waveform. It is calculated as the difference between Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): PP = SBP - DBP. Measurement Method: Measurements will be obtained via manual auscultation using a calibrated sphygmomanometer. SBP is identified at Korotkoff Phase I and DBP at Phase V. To ensure precision, three readings will be taken at 2-minute intervals after a 5-minute rest; the mean values will be used for the final PP calculation. Clinical Significance: In resistant hypertension, PP is a robust indicator of large-artery stiffness and cardiovascular risk. This study evaluates the effect of combined transcutaneous electrical stimulation and isometric exercise on reducing PP, signifying improved vascular compliance and reduced hemodynamic load. Unit of Measure: mmHg
Mean Arterial Blood Pressure
时间窗: 8 weeks
Description: The primary outcome is the change in Mean Arterial Pressure (MAP) from baseline to the end of the intervention. MAP represents the average arterial pressure during a cardiac cycle, serving as a critical indicator of hemodynamic load in patients with resistant hypertension. Measurement \& Calculation: MAP will be determined via the manual auscultatory method using a mercury and a stethoscope. Following a 10-minute quiet rest in a seated position, three readings will be taken from the non-dominant arm (2-minute intervals). SBP and DBP will be recorded at Korotkoff phases I and V. MAP will then be calculated using the formula: MAP = DBP + 1/3(SBP - DBP). Unit of Measure: mmHg
Systolic Blood Pressure (SBP)
时间窗: 8 weeks
Definition: Systolic Blood Pressure (SBP) is the primary measure of peripheral hemodynamics. SBP reflects the maximum pressure exerted against arterial walls during ventricular contraction, while DBP reflects the minimum pressure during ventricular relaxation. Measurement Protocol: Measurements will be performed via manual auscultation using a calibrated sphygmomanometer and a high-quality stethoscope. SBP will be recorded at the onset of Korotkoff Phase I (clear tapping). Participants will rest seated for 5 minutes prior to assessment. Three readings, separated by 2-minute intervals, will be averaged to determine the final values. Clinical Significance: In resistant hypertension, SBP is the gold-standard markers for evaluating the efficacy of the combined transcutaneous electrical stimulation and isometric exercise intervention in reducing systemic vascular resistance and cardiovascular load. Unit of Measurement: mmHg
Heart Rate
时间窗: 8 weeks
Definition: Heart Rate (HR), measured in beats per minute (BPM), serves as a primary indicator of autonomic nervous system activity and cardiovascular workload. In patients with resistant hypertension, it reflects the chronotropic response to the combined intervention. Measurement Method: HR will be measured using a Granzia Pulsox digital pulse oximeter. The device will be placed on the index finger of the participant's non-dominant hand. Following a 5-minute period of seated rest, the investigator will wait for a stable plethysmographic signal on the Granzia display before recording the value. To ensure reliability, three consecutive readings will be taken at 1-minute intervals, and the mean value will be used as the primary data point for analysis. Clinical Significance: A reduction in resting HR would indicate a successful modulation of sympathetic activity following the TENS and isometric exercise protocol.
Diastolic Blood Pressure (DBP)
时间窗: 8 weeks
It is the primary measure of peripheral hemodynamics. DBP reflects the minimum pressure during ventricular relaxation. Measurement Protocol: Measurements will be performed via manual auscultation using a calibrated sphygmomanometer and a high-quality stethoscope. DBP will be recorded at the onset of Korotkoff at Phase V (disappearance of sound). Participants will rest seated for 5 minutes prior to assessment. Three readings, separated by 2-minute intervals, will be averaged to determine the final values. Clinical Significance: In resistant hypertension, DBP is the gold-standard markers for evaluating the efficacy of the combined transcutaneous electrical stimulation and isometric exercise intervention in reducing systemic vascular resistance and cardiovascular load. Unit of Measurement: mmHg
次要结局
- Autonomic parameters: Heart Rate Variability(8 weeks)
- Physiological parameters: Oxygen Saturation(8 weeks)
- Functional parameter: QoL (SF-36)(8 weeks)
- Functional Capacity (modified Harvard step test)(8 weeks)
研究者
Mohamed Mohamed Ali Morgan
Demonstrator of Physical Therapy
Cairo University