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Post-Exercise Hypotension in Elderly Hypertensive Men (HPE)

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic exercise
Combined exercises
Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Bloodpressure, Post-exercise hypotension, Combined exercise, Aerobic exercise, Resistance exercise, Aging, Elderly, Ambulatory blood pressure monitoring

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Essential hypertension grade 1 - 2 with or without medical treatment:

resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg

Exclusion Criteria:

  • Smoking;
  • Bone, joint, or muscle problems that could limit the performance of the exercises.
  • BMI ≥ 30 kg/m2
  • Heart Attack in the last year

Sites / Locations

  • Hospital de Clinicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Aerobic exercise

Combined exercises

Control

Arm Description

Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.

A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.

Participants do not exercise and remain sitting for 45 minutes

Outcomes

Primary Outcome Measures

Ambulatory Blood Pressure Monitoring
Ambulatory blood pressure monitoring following experimental protocols

Secondary Outcome Measures

Office Blood Pressure
Post exercise blood pressure during 60 minutes after experimental sessions

Full Information

First Posted
April 9, 2015
Last Updated
May 29, 2018
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT02415582
Brief Title
Post-Exercise Hypotension in Elderly Hypertensive Men
Acronym
HPE
Official Title
Effects of Different Exercises on Post-Exercise Blood Pressure in Elderly Hypertensive: A Cross-Over Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the effects of two exercise protocols on post-exercise blood pressure versus a control group in elderly hypertensive men. Participants are allocated to all groups: control group and two experimental exercise protocols, in a random order. In the control group, participants remain resting sitting, and, in the exercise protocols, participants practice exercise bouts of aerobic exercise or a combination of resistance and aerobic exercises. In order to standardize baseline conditions, before the sessions subjects remain sitting quietly for 20 minutes. After each exercise protocol, participants have 60 minutes for recovery and, simultaneously, they have BP measured every 5 minutes. After the exercise sessions or control, an equipment for 24 hours ambulatory BP monitoring is installed in every participant.
Detailed Description
Hypertension has high prevalence and low rate of control, and is a major modifiable risk factor and public health problem. Regular physical exercise is a relevant non-pharmacological option for prevention and treatment of hypertension. Several studies demonstrated a reduction in blood pressure (BP) following different exercise protocols, and the decrease may be the result of the summation of hypotensive effects that occur in the hours following the workout. The reduction resulting from a single exercise session is called post-exercise hypotension (PEH) and has been investigated among hypertensive subjects. However, to achieve clinical relevance the PEH should reach a significant magnitude and the reduction should be sustained for a longer period. Previous studies showed the positive effects of aerobic exercise on post-exercise hypotension in hypertensive subjects. However, there is lacking evidence regarding the effects of a single session of aerobic and resistance exercise combined, and the duration of its effect in 24 hours blood pressure in elderly hypertensive subjects. The study is an open, crossover randomized clinical trial, with elderly men allocated to three arms, in a random order: Aerobic training session Combined resistance training and aerobic session Control session After each exercise session, participants have 60 minutes for recovery, performed in the sitting position, with BP measurements every 5 minutes. In addition, participants have measured BP using 24h ambulatory BP monitoring. At the end of the trial, participants will have completed all three experimental protocols: a non-exercise control session, of sitting rest, and two exercise bouts, one of aerobic exercise and a combined resistance and aerobic exercise, with seven days of washout period among sessions. All experiments will be conducted at the same time of day to account for diurnal BP variation. Before the experimental sessions, participants are enrolled in three pre-intervention tests: a familiarization session, cardiopulmonary exercise testing and one maximum repetition strength test (1RM). The aerobic sessions last for 45 minutes, as well as the resistance exercises, and the session of control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Bloodpressure, Post-exercise hypotension, Combined exercise, Aerobic exercise, Resistance exercise, Aging, Elderly, Ambulatory blood pressure monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.
Arm Title
Combined exercises
Arm Type
Experimental
Arm Description
A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants do not exercise and remain sitting for 45 minutes
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
Aerobic exercise on treadmill
Intervention Type
Other
Intervention Name(s)
Combined exercises
Intervention Description
Combined resistance and aerobic exercise
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
45 minutes resting sitting
Primary Outcome Measure Information:
Title
Ambulatory Blood Pressure Monitoring
Description
Ambulatory blood pressure monitoring following experimental protocols
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Office Blood Pressure
Description
Post exercise blood pressure during 60 minutes after experimental sessions
Time Frame
1 hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Essential hypertension grade 1 - 2 with or without medical treatment: resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg Exclusion Criteria: Smoking; Bone, joint, or muscle problems that could limit the performance of the exercises. BMI ≥ 30 kg/m2 Heart Attack in the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra C Fuchs, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil

12. IPD Sharing Statement

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Post-Exercise Hypotension in Elderly Hypertensive Men

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