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

NCT07383220 | Recruiting

• 1 other identifier: P.T.REC/012/006060
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Mean Arterial Pressure; Peripheral Hemodynamics; Physical Therapy; Long Term Hypertension; Resistant HTN; Systolic Blood Pressure (SBP); Diastolic Blood Pressure (DBP); Heart Rate Variability (HRV)

Outcome Measures

Primary Outcomes (5)

• Pulse Pressure

  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

  8 weeks

• Mean Arterial Blood Pressure

  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

  8 weeks

• Systolic Blood Pressure (SBP)

  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

  8 weeks

• Heart Rate

  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.

  8 weeks

• Diastolic Blood Pressure (DBP)

  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

  8 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Combined TENS and Isometric Exercise

EXPERIMENTAL

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.

Device: Transcutaneous Electrical Nerve Stimulation; Behavioral: Isometric Exercise

Conventional Physical Therapy Program

ACTIVE COMPARATOR

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.

Behavioral: Aerobic, Dynamic Resistance, stretch and Breathing Exercises and Lifestyle Modification Advices

Interventions

Transcutaneous Electrical Nerve Stimulation DEVICE

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

Combined TENS and Isometric Exercise

Isometric Exercise BEHAVIORAL

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

Combined TENS and Isometric Exercise

Aerobic, Dynamic Resistance, stretch and Breathing Exercises and Lifestyle Modification Advices BEHAVIORAL

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

Conventional Physical Therapy Program

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Mohamed Ali Morgan: lead

Study Sites (1)

Out Clinics of Port Said Hospitals

Port Said, Port Said Governorate, 42515, Egypt

RECRUITING

MeSH Terms

Conditions

Essential Hypertension; Obesity, Abdominal; Metabolic Syndrome; Hypertension

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise; Breathing Exercises

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Exercise Movement Techniques

Central Study Contacts

Mohamed Mohamed Morgan, Bachelor of Physical Therapy

CONTACT

201026099152; m.morgan@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Demonstrator of Physical Therapy

Model Details: A randomized, two-arm, parallel-group interventional study. Participants with resistant hypertension are assigned to one of two groups. The Experimental Group receives a combined intervention consisting of Transcutaneous Electrical Stimulation (TENS) and Isometric Exercise. The Control Group receives a conventional physical therapy program. Both groups follow their respective protocols concurrently for a period of \[Insert Number\] weeks, with peripheral hemodynamic parameters assessed at baseline and following the completion of the intervention."

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 3, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)