Study to Investigate Effects of Different Therapies for the Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Detailed description: 
      This study deals with a controlled trial and randomized crossover, with intentional
      non-probabilistic sample. All participants were informed of the procedures adopted in the
      research, and then signed the Informed Consent and Informed (IC) according to the resolution
      466/12 of the National Health Council (Annex 1). The initial recruitment of volunteers was
      held in October 2014 with the initial assessments being carried out in the same month, after
      the project is approved by the Ethics Committee and Ethics Studies and Research of the
      Federal University of São Francisco Valley under the registration number 0010 / 240914 CEDEP
      / UNIVASF, and data collection with volunteers was completed in July 2015.

      The plant material of Eucalyptus globulus was collected in January and May 2015 in the city
      Petrolina, Pernambuco state, Brazil. The process of extraction of essential oil of
      eucalyptus, made by hydrodistillation method by Clevenger system. To set the number of survey
      participants was conducted sample calculation by G.Power 3.0 program where the F test was
      chosen - two-way ANOVA for repeated measures between groups and within the group. Whereas
      four (04) experimental sessions and eighteen (18) measures time for each session, as well as
      α = 0.05 and power = 0.80, the sample size of 12 subjects was required.

      Participants were randomly recruited in health centers in the city of Petrolina / PE through
      disclosure / meeting to present the research project, in addition to the collaboration of
      health workers from surrounding neighborhoods to UNIVASF.

      All participants were divided into blocks in accordance with CONSORT criteria. Initially, the
      research project, along with the IC, was presented to each of the candidates to volunteer,
      with discussion of the risks and benefits, both scientific and individual would be likely to
      compose the study sample. After agreeing on participation, and application of history about
      health history, readiness for exercise and risk stratification according to guidelines from
      the American College of Sports Medicine, the informed consent was signed, and then scheduled
      with the volunteer the day and time of the completion of resting ECG examination (held in a
      large hospital in Petrolina / PE and funded by the researchers), to check for possible
      abnormalities and ischemia suggestion above or below unevenness in the ST segment> 2 mm or
      inversion of the T wave. All ECG's 12-lead were performed and evaluated by a cardiologist,
      where no examination apesentou suggestion ischemia or abnormality that would prevent
      volunteer to carry out all stages of safely search. After meeting and selection of the sample
      in accordance with the guidelines on inclusion profile, participants were invited to attend
      the morning to CEFIS of UNIVASF to carry out the anthropometric measurements (height, weight,
      body mass index, waist circumference and body fat percentage), and schedule for the start of
      the experimental sessions.

      Volunteers had the orientation to suspend the anti-hypertensive medication on the day of each
      session, and only return to use after the removal of equipment (next day) by the researcher.
      In addition to this recommendation, the volunteers should not eat on the day of the
      interventions, substances that contain caffeine, alcohol, chocolate, tea, passion fruit or
      any other stimulant or CNS retardant, but the eating routine should be followed. The practice
      of physical activity, including sexual, was banned in the days that applied sessions.

      On different days, with an interval of at least 72 hours, and in a randomized order,
      acupuncture, aerobic exercise, inhalation of essential oil of eucalyptus, and control were
      applied. In order to minimize the influence of the circadian rhythm, the sessions were always
      made at the same time of day (between 8 am and 9 am). Each treatment lasted for twenty (20)
      minutes. The living laboratory procedures was controlled temperature between 23 ° C and 24 °
      C for all sessions.

      The acupuncture session (ACUP) were placed, and maintained for 20 minutes so perpendicularly
      to the skin, two specific needles, stainless steel, sterilized and disposable (one on each
      arm) of 0.25mm brand Dongbang x 0.30 mm, in Section 6 of the pericardium channel (Neiguan),
      located 2 tsun (approximately 5 cm) proximal to the crease of the wrist, ventral aspect.

      The aerobic exercise session (EXER) was conducted through 20-minute walk or jog on a
      treadmill of CEFISE brand, model TK30 (Campinas, BRA). The intensity was equivalent to 60% of
      the RHR (maximal HR - resting HR x 0.6 + HR rest).

      In session eucalyptus essential oil (OIL) the subject sat, as in the rest time, and remained
      breathing naturally for 20 minutes with a disposable face mask, soaked in 0.25 ml of
      essential oil of eucalyptus measured by Adjustable Pipettor Kacil DSA ® Model 100 / 1000μl.

      The session control (CONT) volunteers remained seated on standing for 20 minutes in the same
      manner and same chair used in acupuncture and inhalation of essential oils, but without
      performing any treatment.

      The BP was assessed by ABPM device brand Meditech ABPM-04 (Micromed, BRA). The contents of
      the BP analyzed in this study were: systolic BP (SBP); Diastolic BP (DBP); BP Average (PAM),
      as follows: MAP = DAP + [(PAS-DAP) / 3]; Pressure overload (percentage> 125/75 mmHg in 24
      hours;> 130 / 85mmHg in the Vigil and> 110/70 in Sleep, respectively for SBP and DBP); Night
      decline (relative percentage difference between the average sleep BP and the BP in the wake
      average). The measurements were taken every 15 minutes during daytime and every 30 minutes
      during sleep.

      HRV was analyzed through the records of RRi intervals obtained by heart rate monitor brand
      Polar RS800CX model (Polar Electro Oy, FI-90440 KEMPELE, Finland) and this validated
      equipment and high reproducibility. The HRV indexes were analyzed by linear methods in the
      time domain (RRi, RMSSD, pNN50) and frequency (LF, HF and LF: HF), and the non-linear method
      by the standard deviation of RRI intervals (SD1). Records of RRi series were captured and
      recorded on the watch belonging to the equipment, continuously throughout the period of the
      day after the session, and analyzed using the software Kubios v. 2.0 at intervals of 5
      minutes.

      Descriptive statistical averaging procedures, standard deviation (SD) and standard error of
      the mean (SEM) was adopted. Shapiro-Wilk test for normality analysis was used, and in case of
      normality given a two-way ANOVA for repeated measures was performed post-hoc Tukey. For
      non-parametric data we used nonparametric ANOVA for analysis. The level of the study
      significance was set at p <0.05, using the Statistica software version 7.0.
    

Intervention name(s): Acupuncture; Aerobic exercise; Aromatherapy
Intervention type(s): Device; Device; Device
Intervention description(s): Acupuncture in point 6 of the pericardium channel (neiguan) bilaterally; aerobic exercise of moderate intensity; inhalation of eucalyptus essential oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapies. Autonomic nervous system. Cardiovascular stress