NCT02656004

Brief Summary

The essential eucalyptus oil has therapeutic potential in the cardiovascular system, with possibilities of acting on the autonomic tonus and reduction of cardiovascular overload. Hemodynamic conditions can change during the physical requirement and offer a framework of increased cardiovascular risk, especially for elderly individuals. In this sense, preservation strategies of cardiovascular autonomic control and demand in this population in conditions of rest and/or exercise are required. The aim of this study was investigate the effect of the essential eucalyptus oil on cardiovascular responses and recovery during submaximal isometric resisted exercise series in the elderly. Twenty elderly male (69.1 ± 5.7 years; 75.3 ± 12.3 kg; 168.0 ± 6.0 cm) participated in this study. Were excluded from the sample the volunteers who presented some serious illness known according to the criteria of risk stratification of the American College of Sports Medicine. In random order crusade, the volunteers were subjected to: 1) trial session through the essential eucalyptus oil and inhalation; 2) session control without inhalation of essential eucalyptus oil. After the sessions 1 and 2, the volunteers remained in recovery for a period of 60 minutes, in temperature-controlled environment and comfortably seated. After this period were performed 3 sets of isometric resisted exercise on dominant upper limb in intensity of 30% of maximum voluntary contraction in 1 min each, with 1 min recovery interval. Measures of heart rate, blood pressure, rate product pressure and heart rate variability were held in the rest for 20 min, in recovery during 60 min and during the 3 sets of isometric resisted exercise. Indicators of heart rate variability were analysed from the time and the frequency domain. ANOVA two-way for repeated measurements with Post Hoc of Tukey were employed (p\<0.05).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable hypertension

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

August 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

January 11, 2016

Last Update Submit

January 12, 2016

Conditions

Keywords

EucalyptusAutonomic nervous systemIsometric resistance exercise

Outcome Measures

Primary Outcomes (1)

  • Blood pressure response to Inhalation of Essential Eucalyptus Oil

    2 hours

Study Arms (2)

Essential Eucalyptus Oil

EXPERIMENTAL

Using a disposable face mask was inhale for ten minutes 0.25 ml of essential oil of eucalyptus measured through adjustable Pipettor 100/1000μl. Inhalation of the substance occurred immediately after the 20 minute rest period in the session Essential Oil of Eucalyptus.

Other: Essential Eucalyptus Oil

Control

EXPERIMENTAL

In the control session the procedure was the same. Using a disposable face mask was inhale for ten minutes fresh air. Inhalation of the fresh air occurred immediately after the 20 minute rest period in the session Control.

Other: Control Session

Interventions

Using a disposable face mask was inhale for ten minutes 0.25 ml of essential oil of eucalyptus measured through adjustable Pipettor 100/1000μl. Inhalation of the substance occurred immediately after the 20 minute rest period in the session Essential Oil of Eucalyptus.

Essential Eucalyptus Oil

In the control session the procedure was the same. Using a disposable face mask was inhale for ten minutes fresh air. Inhalation of the fresh air occurred immediately after the 20 minute rest period in the session Control.

Control

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and hypertensive
  • Between 60 and 80 years old

You may not qualify if:

  • Diabetic
  • Morbid obesity
  • Abnormality on the electrocardiogram at rest with ischemic heart suggested
  • Heart disease
  • Uncontrolled hypertension
  • Chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 14, 2016

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

August 1, 2014

Last Updated

January 14, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share