Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial

Effect of Foot Reflexology on Blood Pressure and Pulse Rate: A Randomized Clinical Trial in Stage-2 Hypertensive Patients

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.

Study Overview

• Status: Completed
• Conditions: Reflexology, Hypertension, Acupressure, Traditional Medicine
• Intervention / Treatment: Procedure: foot reflexology

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: foot reflexology; Foot reflexology was performed in every participant in the foot reflexology group after resting for 5 minutes in a sitting position by the same researcher who was trained and certified by the Department of Thai Traditional and Alternative Medicine, Ministry of Health.	Procedure: foot reflexology; Acupressure was applied at the plantar side of the right foot at the first metatarsal bone, around 1-1.5 centimeters proximal to the first metatarsophalangeal joint. (Figure 2) Approximately 3-kilogram pressure was applied by using a knuckle of the right index finger (dorsal part of the proximal interphalangeal joint in flexing position) in a perpendicular manner and held for 15 seconds (sec) then released for 5 sec. This hold-release cycle was done 5 times over the course of 2 min. This method was recommended by the Department of Thai Traditional and Alternative Medicine in accordance with the Zone theory and the Meridian theory.
No Intervention: control; The control group received conventional treatment including anti-HT medications according to the standard HT guideline's recommendations. In the end of the follow-up visit, every participants were informed to adhere to their medication and were encouraged to have healthy lifestyles including salt restriction, regular exercise, and consuming healthy diets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of blood pressure level	The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses.	Change from Baseline Systolic Blood Pressure at 15 minutes
Change of blood pressure level	The office blood pressures (BP) were measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office BPs were measured at baseline and after resting in a quiet room for 15 and 30 min. A validated, FDA-approved automatic BP device (DINAMAP Pro 300, GE healthcare) with the appropriate cuff size for individual arm circumference was used for measurement. Two BP measurements were taken at 2-min intervals, and the average BP were recorded for analyses.	Change from Baseline Systolic Blood Pressure at 30 minutes
Change of pulse rate	The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min.	Change from baseline pulse rate at 15 minutes
Change of pulse rate	The office pulse rate (PR) was measured by a nurse at baseline and at 15 and 30 min after foot reflexology was done in the intervention group. While in the control group, office PR was measured at baseline and after resting in a quiet room for 15 and 30 min.	Change from baseline pulse rate at 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in degree of reduction of blood pressure between groups	Compare the degree of reduction of blood pressure between intervention and control group	Difference in degree of reduction of blood pressure from baseline after 30 min
Difference in degree of reduction of pulse rate between groups	Compare the degree of reduction of pulse rate between intervention and control group	Difference in degree of reduction of pulse rate from baseline after 30 min

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: hypertension; reflexology; acupressure; traditional medicine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: HE611181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Personal contact for IPD
• IPD Sharing Time Frame: Until 31st December 2020
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No