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Effect of Electrical Stimulation and Exercise on Blood Flow in Patients With Resistant High Blood Pressure

ClinicalTrials.gov IDNCT07383220

PhaseNA

Enrollment50

SponsorMohamed Mohamed Ali Morgan

Age50 Years

SexALL

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Conditions studied

Resistant Hypertension, Hemodynamic Instability, Essential (Primary) Hypertension, Abdominal Obesity, Metabolic Syndrome, Hypertension (HTN), Vascular Resistance, High Blood Pressure

About this study

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

Interventions

Device: Transcutaneous Electrical Nerve Stimulation — Application of TENS 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 Intensity: strong but comfortable tingling sensations, below motor threshold (typically between 10-20mA) Session duration: 30 minutes per session Session frequency: 3 times per week Total intervention duration: 8 weeks
Behavioral: Isometric Exercise — Device: Hand grip dynamometer. protocol: * 30% of the participants' maximal voluntary contraction (MVC). * Duration per trial: 2 minutes. * Number of trials per session: 4 repetitions * Rest interval between trials: 1 minute * Session frequency: 3 sessions per week * Total session duration: 14 minutes Per session: * 4 sets × 2 minutes = 8 minutes of active contraction * Rest between sets: 1 to 3 minutes (average 2 min × 3 rests = 6 minutes) * So total session time: average 14 minutes. • Total intervention duration: 8 weeks
Behavioral: Aerobic, Dynamic Resistance, stretch and Breathing Exercises and Lifestyle Modification Advices — 1. Aerobic exercise: moderate (brisk walking): 30 min, 5 times per week. 2. Engage in dynamic resistance exercise (weight training): 2 or more days non-consecutive. 3. Minimize sedentary behavior 4. Maintain healthy weight 5. Nutritional advice like: * Eat at least 5 portions of fruit and vegetables * Eat more lean protein e.g. Fish and nuts * Eat less salt \<5g or 1tsp * Eat 25-29 g of fiber * Limit alcohol * Drink 2-3 cups of coffee and/or tea (unsweetened) 6. Others: * Sleep: 7-9h/day * Reduce stress: practice meditation or yoga 30 min per day * Listen to music at least 25 min, 3 times per week * Stop smoking * Limit pollutions exposure * Use digital wearables/apps to track movement 7. Breathing exercise: Slow breathing at a rate of 6 breath/min for 10 minutes. 8. Stretching exercise: Static stretching exercise is mainly for large bulky muscles 30 sec stretch, 30 sec rest for 5 min

Primary outcomes

Pulse Pressure (8 weeks)
Mean Arterial Blood Pressure (8 weeks)
Systolic Blood Pressure (SBP) (8 weeks)
Heart Rate (8 weeks)
Diastolic Blood Pressure (DBP) (8 weeks)

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

Out Clinics of Port Said Hospitals, Port Said, Port Said Governorate 42515 Egypt

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.