Acute Effects of Different Exercises on Blood Pressure in Hypertensive Subjects

Hypertension Clinical Trial

Official title:

Hemodynamic, Autonomic and Inflammatory Answers to Different Types of Exercises in Resistant Hypertensive Patients: an Metabolomic Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02987452
• Other study ID #: 55942216.4.0000.5404
• Status: Not yet recruiting
• Phase: N/A
• First received: December 6, 2016
• Last updated: December 13, 2016
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: December 2016
• Source: University of Campinas, Brazil
• Contact: Nayara F. Pires, PhD student
• Phone: +551935219538
• Email: nayarafraccari[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive (RHTN) patients, have not been investigated yet.

Description:

Objective: The investigators aim to evaluate the acute effects of aerobic, resistance and combined (aerobic+ resistance) exercise on the BP, hemodynamic and inflammatory parameters, as well as arterial stiffness in RHTN patients compared to mild to moderate hypertensive (HTN) and normotensive (NT) subjects. Design and Methods: This interventional, randomized, single-blind, crossover study will be conducted in 30 patients (RHTN=10, HTN=10, and NT=10) regularly followed in the Outpatient Resistant Hypertension Clinic at UNICAMP- Brazil. All the subjects will be submitted to a previous adaptation of physical activity, especially to determine the load to be implemented in each patient. Then, the modalities of physical exercises (aerobic, resistance and combined) will be randomly performed in three isolated sessions, which will consist of: a) Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test; b) resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes; c) combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes. Body composition (plethysmography) and cardiorespiratory functional capacity (ergometry) will be determined before the physical training. In addition, the investigators will assess BP recording (by Finometer, office and ambulatory BP), arterial stiffness (by pulse wave velocity, Sphygmocor CPV system), plasma biomarkers (TNF-α, interleukins -1, -6, -10, and -17 by ELISA) in pre and post periods of each physical exercise. Results: Since the physical exercise in its different modalities provides chronic effects on BP in HTN patients, the investigators hypothesized that the isolated (aerobic and resistance) and combined exercise can acutely promote changes in BP levels in RHTN patients when compared to the participants counterparts. Secondarily, some biological mechanisms related to BP control (vascular function and cytokines production) may also be involved in these possible alterations. Conclusion: The investigators expect to define whether a physical exercise program applied to RHTN patients has medical relevance in a realistic clinical setting. These findings may guide the prescription of physical activity as an additional therapeutic approach, in order to decrease the cardiovascular risk associated to these subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008)

• a 6-month period clinic follow-up

• give written informed consent form

Exclusion Criteria:

• secondary Hypertension

• pseudoresistance hypertension (poor medication adherence and white coat hypertension)

• patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases, heart failure

• pregnant women

• smoking

• regular physical activity

• mental or physical limitation

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• aerobic exercise
Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
• resistance exercise
resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
• combined exercise
combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heitor Moreno Junior

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure in mmHg	systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.	15 minutes	No
Secondary	arterial stiffness	by pulse wave velocity, Sphygmocor CPV system	baseline and 60 minutes post each intervention	No
Secondary	ambulatory blood pressure monitoring	ambulatory blood pressure will be assessed in baseline and post each intervention	baseline and post each intervention	No
Secondary	interleukin 6	interleukin 6 will be assessed by ELISA	baseline, 60 minutes and 24 hours post each intervention	No
Secondary	interleukin 10	interleukin 10 will be assessed by ELISA	baseline, 60 minutes and 24 hours post each intervention	No
Secondary	tumor necrosis factor alpha	tumor necrosis factor alpha will be assessed by ELISA	baseline, 60 minutes and 24 hours post each intervention	No