Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Trial
August 19, 2015 updated by: Hospital de Clinicas de Porto Alegre
Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Randomized Controlled Trial
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Hospital de Clínicas de Porto Alegre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
sited rest for 45 minutes
|
|
|
Experimental: higher intensity aerobic exercise
45 minutes of aerobic exercise at 75%HRmax
|
aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
|
|
Experimental: lower intensity aerobic exercise
45 minutes of aerobic exercise at 50%HRmax
|
aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ambulatory Blood Pressure Monitoring
Time Frame: 22h
|
22h
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forearm blood flow
Time Frame: 1h
|
Accessed by venous occlusion plethysmography.
Compared with pre-intervention values
|
1h
|
|
Reactive hyperemia
Time Frame: pre and 30min post
|
Accessed by venous occlusion plethysmography.
|
pre and 30min post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Umpierre, PhD, Federal University of Health Science of Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 24, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Estimate)
August 20, 2015
Last Update Submitted That Met QC Criteria
August 19, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-0309 (Other Identifier: CEP-HCPA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.