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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249507
• Other study ID #: 13-0309
• Secondary ID: 13-0309
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: August 19, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• aerobic exercise
aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Blood Pressure Monitoring		22h	No
Secondary	Forearm blood flow	Accessed by venous occlusion plethysmography. Compared with pre-intervention values	1h	No
Secondary	Reactive hyperemia	Accessed by venous occlusion plethysmography.	pre and 30min post	No