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

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

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: aerobic exercise

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

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital De Clinicas De Porto Alegre

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

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	Other: aerobic exercise; aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
Experimental: lower intensity aerobic exercise; 45 minutes of aerobic exercise at 50%HRmax	Other: aerobic exercise; 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	22h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forearm blood flow	Accessed by venous occlusion plethysmography. Compared with pre-intervention values	1h
Reactive hyperemia	Accessed by venous occlusion plethysmography.	pre and 30min post

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Daniel Umpierre, PhD, Federal University of Health Science of Porto Alegre

Study record dates

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: Aerobic Exercise; Resistant Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 13-0309 (Other Identifier: CEP-HCPA)