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

NCT ID: NCT04516005

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2016-10-31

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.

Conditions

Reflexology, Hypertension, Acupressure, Traditional Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

foot reflexology

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Praew Kotruchin

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HE611181

Identifier Type: -

Identifier Source: org_study_id