Clinical trial NCT04516005: Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial
Official title: Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial in Stage-2 Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reflexology, Hypertension, Acupressure, Traditional Medicine
Keywords: hypertension
reflexology
acupressure
traditional medicine
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-center randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere with them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of a complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT. We aimed to examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering. This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.

Detailed description: Background Hypertension (HT) has been known for its prominent risk of cardiovascular events. Although there are various pharmacological choices, many patients fail to adhere to them. Therefore, adjunctive non-pharmacological treatment is a promising approach. Foot Reflexology is one of the complementary therapies that has been proved for its ability to decrease blood pressure (BP), however, there is limited data in patients with stage-2 HT.

Objective To examine the effectiveness of foot reflexology as adjunctive therapy for BP lowering.

Methods This was a single-center randomized clinical trial. Hypertensive patients who were regularly followed up at the hypertension clinic were enrolled and randomized into the intervention group (n=47) and control group (n=47). Foot reflexology was performed in the intervention group during a clinical visit. Office BP and pulse rate (PR) were measured before and immediately at 15 minutes (min) and 30 min after the procedure in the intervention group and after resting in the control group.

Eligibility criteria: Inclusion Criteria:

* Diagnosed stage-2 HT (defined by office SBP≥140 mmHg and/or DBP ≥90 mmHg at first hospital visit)
* On stable anti-HT drugs for at least 3 months before enrollment.

Exclusion Criteria:

* Pregnant women
* History of foot surgery or bone fracture
* Skin disease of the foot
* Diabetes neuropathy

Primary outcomes:
measure: Change of blood pressure level
timeFrame: Change from Baseline Systolic Blood Pressure at 15 minutes
measure: Change of blood pressure level
timeFrame: Change from Baseline Systolic Blood Pressure at 30 minutes
measure: Change of pulse rate
timeFrame: Change from baseline pulse rate at 15 minutes
measure: Change of pulse rate
timeFrame: Change from baseline pulse rate at 30 minutes
Secondary outcomes:
measure: Difference in degree of reduction of blood pressure between groups
timeFrame: Difference in degree of reduction of blood pressure from baseline after 30 min
measure: Difference in degree of reduction of pulse rate between groups
timeFrame: Difference in degree of reduction of pulse rate from baseline after 30 min
Other outcomes:
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