Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Trial

NCT ID: NCT02249507

Last Updated: 2015-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-05-31

Brief Summary

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Aerobic exercise has the potential to diminish blood pressure values. The aim of this study is to determine whether this potential is also applicable for those with resistant hypertension and whether exercise intensity plays a role in this context. We hypothesize that performing an aerobic exercise session reduces blood pressure values in resistant hypertensive patients in a dose-response relation with exercise intensity.

Detailed Description

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Exercise prescription is gathering great importance in preventive health. Several organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk of higher intensities in order to achieve better health parameters in different contexts. Aerobic exercise is known to be an effective way to diminish BP levels post-session. These responses are widely applicable in hypertensive subjects, acting in aid of BP management treatment. Although these benefits of aerobic exercise are well known, few studies explore the potential of this intervention in resistant-to-treatment patients. Moreover, the effects different intensities of aerobic exercise in this population is scarce. Thus, the aim of this study is to determine the magnitude of BP responses, if there is any, of resistant hypertensive subjects to two different intensities of aerobic exercise, compared with a control session. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise testing and three randomized intervention sessions: control, 50%HRmax and 75%HRmax. Prior and immediately after all intervention sessions (during 1h), forearm blood flow and reactive hyperemia will be assessed by venous occlusion plethysmography. After the sessions, 24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

sited rest for 45 minutes

Group Type NO_INTERVENTION

No interventions assigned to this group

higher intensity aerobic exercise

45 minutes of aerobic exercise at 75%HRmax

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type OTHER

aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)

lower intensity aerobic exercise

45 minutes of aerobic exercise at 50%HRmax

Group Type EXPERIMENTAL

aerobic exercise

Intervention Type OTHER

aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)

Interventions

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aerobic exercise

aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

resistant-to-treatment hypertensive subjects (24h ambulatory BP above 130/80, or daytime ambulatory BP above 135/85, or night-time ambulatory BP above 120/70 in spite use of 3 anti-hypertensive medications of different classes, being one diuretic; or use of 4 or more anti-hypertensive medications).

Exclusion Criteria

Muscle or skeletal abnormalities that preclude effort, abnormal exercise stress test, major illnesses that would preclude exercise effort or could influence in the outcome variables (pulmonary disease, valve disease, renal insufficiency, etc.)
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Umpierre, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

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Hospital de ClĂ­nicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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13-0309

Identifier Type: OTHER

Identifier Source: secondary_id

13-0309

Identifier Type: -

Identifier Source: org_study_id

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