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Study to Investigate Effects of Different Therapies for the Treatment of Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02637336
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco
Information provided by (Responsible Party):
Marcus Amando Fernandes da Silva, Universidade Federal do vale do São Francisco

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Acupuncture Device: Aerobic exercise Device: Aromatherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Cardiovascular Responses in Hypertensive Individuals
Study Start Date : March 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acupuncture
acupuncture session were inserted, and maintained for 20 minutes in paragraph 6 of the channel the pericardium (Neiguan).
Device: Acupuncture
Acupuncture in point 6 of the pericardium channel (neiguan) bilaterally

Experimental: Aerobic Exercise
The aerobic exercise session was conducted through 20 minutes.
Device: Aerobic exercise
aerobic exercise of moderate intensity

Experimental: Aromatherapy
Eucalyptus essential oil was inhaled by volunteers for 20 minutes
Device: Aromatherapy
inhalation of eucalyptus essential oil

No Intervention: Control
In the control session the volunteers remained seated at rest for 20 minutes without performing therapy.

Primary Outcome Measures :
  1. Blood pressure outside the laboratory [ Time Frame: 16 hours ]

Secondary Outcome Measures :
  1. Blood pressure in the laboratory [ Time Frame: 02 hours ]
  2. Heart rate variability in the laboratory [ Time Frame: 02 hours ]
  3. Heart rate variability outside the laboratory [ Time Frame: 16 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hypertensive mens;
  • clinically stable.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02637336

Sponsors and Collaborators
Universidade Federal do vale do São Francisco
Fundação de Amparo à Ciência e Tecnologia do Estado de Pernambuco
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Principal Investigator: Marcus AF Silva UNIVASF

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Responsible Party: Marcus Amando Fernandes da Silva, Master's Degree student, Universidade Federal do vale do São Francisco Identifier: NCT02637336    
Other Study ID Numbers: UNIVASF
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015
Keywords provided by Marcus Amando Fernandes da Silva, Universidade Federal do vale do São Francisco:
Therapies. Autonomic nervous system. Cardiovascular stress
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases