HypertensionNCT02656004
Essential Oil of Eucalyptus Effect on Cardiovascular Responses
A study testing Essential Eucalyptus Oil in people with Hypertension, run by Universidade Federal do vale do São Francisco.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Essential Eucalyptus Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and hypertensive
- Between 60 and 80 years old
Who cannot join
- Diabetic
- Morbid obesity
- Abnormality on the electrocardiogram at rest with ischemic heart suggested
- Heart disease
- Uncontrolled hypertension
- Chronic renal failure
About this study
Official title: Essential Oil of Eucalyptus Effect on Cardiovascular Responses During Recovery of Elderly and Isometric Resistance Exercise
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).
Read the detailed description
The volunteers performed in random order two experimental sessions separated by 48 hours and being: 1) Control and; 2) Inhalation Essential Oil of Eucalyptus. The experimental sessions were always performed in the morning and in the same time of day for the same volunteer, avoiding possible influences circadian rhythm. The experimental sessions were held at the Exercise Physiology Laboratory at the Federal University of Vale do São Francisco with controlled temperature 25°C. At times the pre session (rest), recovery and during the isometric resistance exercise (post-session) in upper limb by hand grip, blood pressure measurements were taken, heart rate and records of the intervals R-R in the absolute time and frequency domain, and are calculated the rate product pressure values (systolic blood pressure x heart rate). Using a disposable face mask participants 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. In the control session the volunteers remained in a similar manner, with the installed face mask, however inhaling fresh air. The test for determining the maximal voluntary contraction was held in hand grip device Hydraulic Hand Dynamometer Saehan Model SH5001 ranging from 0-90 kgf of grip and precision of 2 kgf. Before the test was performed familiarization session with two series each of 10 seconds with the minimum load allowed by the equipment, the series being separated by a 2-minute recovery period. The value of the maximum voluntary load was determined by the highest value obtained in three attempts of 10 seconds each, with 2 minutes between each trial and the position of the grip handle has been self selected. The experimental isometric resistance exercise sessions were undertaken after 48 hours of interval maximum voluntary contraction test, and the same equipment previously used for the test. The isometric resistance exercise series were held with volunteers sitting positioned comfortably and with the shoulder adducted, the elbow flexed at 90° and the forearm in neutral position, and the position of the self selected grip handle. The highest value obtained in kgf in maximum voluntary contraction test was used as a reference to calculate the absolute intensity of the exercise, which was corresponding to the relative intensity of 30% of the test. Three sets were performed with duration of 1 minute recovery at the same time in both sessions (Eucalyptus Essential Oil and Control).
- Conditions
- Hypertension
- Being tested
- Essential Eucalyptus Oil, Control Session
- Keywords
- Eucalyptus, Autonomic nervous system, Isometric resistance exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Eucalyptus OilOther
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.
Control SessionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure response to Inhalation of Essential Eucalyptus Oil
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do vale do São Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Anderson Teixeira de Araujo, Universidade Federal do vale do São Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656004
- Sponsor's protocol ID
- UFSaoFrancisco2
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Oil of Eucalyptus Effect on Cardiovascular Responses During Recovery of Elderly and Isometric Resistance Exercise
- ClinicalTrials.gov ID
- NCT02656004
- Acronym / sponsor ID
- UFSaoFrancisco2
- Conditions
- Hypertension
- Keywords
- Eucalyptus, Autonomic nervous system, Isometric resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do vale do São FranciscoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The volunteers performed in random order two experimental sessions separated by 48 hours and being: 1) Control and; 2) Inhalation Essential Oil of Eucalyptus. The experimental sessions were always performed in the morning and in the same time of day for the same volunteer, avoiding possible influences circadian rhythm. The experimental sessions were held at the Exercise Physiology Laboratory at the Federal University of Vale do São Francisco with controlled temperature 25°C. At times the pre session (rest), recovery and during the isometric resistance exercise (post-session) in upper limb by hand grip, blood pressure measurements were taken, heart rate and records of the intervals R-R in the absolute time and frequency domain, and are calculated the rate product pressure values (systolic blood pressure x heart rate). Using a disposable face mask participants 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. In the control session the volunteers remained in a similar manner, with the installed face mask, however inhaling fresh air. The test for determining the maximal voluntary contraction was held in hand grip device Hydraulic Hand Dynamometer Saehan Model SH5001 ranging from 0-90 kgf of grip and precision of 2 kgf. Before the test was performed familiarization session with two series each of 10 seconds with the minimum load allowed by the equipment, the series being separated by a 2-minute recovery period. The value of the maximum voluntary load was determined by the highest value obtained in three attempts of 10 seconds each, with 2 minutes between each trial and the position of the grip handle has been self selected. The experimental isometric resistance exercise sessions were undertaken after 48 hours of interval maximum voluntary contraction test, and the same equipment previously used for the test. The isometric resistance exercise series were held with volunteers sitting positioned comfortably and with the shoulder adducted, the elbow flexed at 90° and the forearm in neutral position, and the position of the self selected grip handle. The highest value obtained in kgf in maximum voluntary contraction test was used as a reference to calculate the absolute intensity of the exercise, which was corresponding to the relative intensity of 30% of the test. Three sets were performed with duration of 1 minute recovery at the same time in both sessions (Eucalyptus Essential Oil and Control).
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essential Eucalyptus Oil | Experimental | Other: Essential Eucalyptus OilUsing 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. |
| Control | Experimental | Other: Control SessionIn 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy men and hypertensive
- Between 60 and 80 years old
Key exclusion criteria (6 listed)
- Diabetic
- Morbid obesity
- Abnormality on the electrocardiogram at rest with ischemic heart suggested
- Heart disease
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Eucalyptus OilUsing 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 SessionIn 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 |
Primary outcome
Blood pressure response to Inhalation of Essential Eucalyptus Oil
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Eucalyptus Oil in people with Hypertension, run by Universidade Federal do vale do São Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure response to Inhalation of Essential Eucalyptus Oil (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.