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

Primary Purpose

Reflexology, Hypertension, Acupressure, Traditional Medicine

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
foot reflexology
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reflexology, Hypertension, Acupressure, Traditional Medicine focused on measuring hypertension, reflexology, acupressure, traditional medicine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    foot reflexology

    control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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 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 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 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.

    Secondary Outcome Measures

    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 pulse rate between groups
    Compare the degree of reduction of pulse rate between intervention and control group

    Full Information

    First Posted
    August 10, 2020
    Last Updated
    August 13, 2020
    Sponsor
    Khon Kaen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04516005
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2015 (Actual)
    Primary Completion Date
    May 31, 2016 (Actual)
    Study Completion Date
    October 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Khon Kaen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reflexology, Hypertension, Acupressure, Traditional Medicine
    Keywords
    hypertension, reflexology, acupressure, traditional medicine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    a single-center randomized clinical trial
    Masking
    Investigator
    Masking Description
    The statistical analysis investigator was blinded to the randomization group
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    foot reflexology
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    foot reflexology
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change of blood pressure level
    Description
    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.
    Time Frame
    Change from Baseline Systolic Blood Pressure at 15 minutes
    Title
    Change of blood pressure level
    Description
    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.
    Time Frame
    Change from Baseline Systolic Blood Pressure at 30 minutes
    Title
    Change of pulse rate
    Description
    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.
    Time Frame
    Change from baseline pulse rate at 15 minutes
    Title
    Change of pulse rate
    Description
    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.
    Time Frame
    Change from baseline pulse rate at 30 minutes
    Secondary Outcome Measure Information:
    Title
    Difference in degree of reduction of blood pressure between groups
    Description
    Compare the degree of reduction of blood pressure between intervention and control group
    Time Frame
    Difference in degree of reduction of blood pressure from baseline after 30 min
    Title
    Difference in degree of reduction of pulse rate between groups
    Description
    Compare the degree of reduction of pulse rate between intervention and control group
    Time Frame
    Difference in degree of reduction of pulse rate from baseline after 30 min

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Personal contact for IPD
    IPD Sharing Time Frame
    Until 31st December 2020

    Learn more about this trial

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

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