NCT02637336

Brief Summary

The aim of this study was to evaluate the acute cardiovascular responses in hypertensive individuals, in waking and sleeping periods after application of different non-pharmacological therapies for the control of blood pressure (BP). Randomly and random volunteers held a session of each therapy: Acupuncture, aerobic exercise, essential oil inhalation, and session control with a minimum interval of 72 hours between them. On the day of sessions the volunteers did not use antihypertensive medication. The variables measured in the survey were the blood pressure and heart rate variability (HRV). Descriptive statistical averaging procedures, standard deviation and standard error of mean were adopted. Two-way ANOVA for repeated measures was performed post-hoc Tukey. The level of the study significance was set at p \<0.05.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.3 years

First QC Date

December 14, 2015

Last Update Submit

December 21, 2015

Conditions

Hypertension

Keywords

Therapies. Autonomic nervous system. Cardiovascular stress

Outcome Measures

Primary Outcomes (1)

  • Blood pressure outside the laboratory

    16 hours

Secondary Outcomes (3)

  • Blood pressure in the laboratory

    02 hours

  • Heart rate variability in the laboratory

    02 hours

  • Heart rate variability outside the laboratory

    16 hours

Study Arms (4)

Acupuncture

EXPERIMENTAL

acupuncture session were inserted, and maintained for 20 minutes in paragraph 6 of the channel the pericardium (Neiguan).

Device: Acupuncture

Aerobic Exercise

EXPERIMENTAL

The aerobic exercise session was conducted through 20 minutes.

Device: Aerobic exercise

Aromatherapy

EXPERIMENTAL

Eucalyptus essential oil was inhaled by volunteers for 20 minutes

Device: Aromatherapy

Control

NO INTERVENTION

In the control session the volunteers remained seated at rest for 20 minutes without performing therapy.

Interventions

AcupunctureDEVICE

Acupuncture in point 6 of the pericardium channel (neiguan) bilaterally

Acupuncture
Aerobic exerciseDEVICE

aerobic exercise of moderate intensity

Aerobic Exercise
AromatherapyDEVICE

inhalation of eucalyptus essential oil

Aromatherapy

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • hypertensive mens;
  • clinically stable.

You may not qualify if:

  • Abnormalities in Resting ECG with cardiac ischemia suggestion;
  • Rank in Category 3 (known serious illness) the risk stratification of the American College of Sports Medicine;
  • Use of beta blocker medicine;
  • Heart or kidney failure;
  • Stroke history, coronary or peripheral arterial disease;
  • Decompensated diabetes with blood glucose greater than 300 mg.dL-1;
  • Autonomic dysfunction or severe peripheral;
  • Any amputation of limbs; Regular physical activity practice (\> 150 minutes per week) in the last 06 months;
  • Uncontrolled hypertension with systolic blood pressure above 160 mmHg and diastolic blood pressure above 105 mmHg without medication;
  • Abnormality in the blood coagulation;
  • Allergy to the material of the acupuncture needle (stainless steel).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Interventions

Acupuncture TherapyAromatherapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsMind-Body TherapiesPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marcus AF Silva

    UNIVASF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree student

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 22, 2015

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12