Post-Exercise Hypotension After Water Exercise

July 20, 2017 updated by: Instituto de Cardiologia do Rio Grande do Sul

Post-Exercise Hypotension After Water Exercise in Older Women With Hypertension: A Randomized Crossover Clinical Trial

Hypertension is the most prevalent cardiovascular disease risk factor among individuals 60 years of age and older. Hypertension can be prevented and modified with lifestyle interventions that include regular exercise. Water exercise is widely recommended for older adults for a variety of health benefits, but few studies have assessed the immediate ambulatory blood pressure (BP) response to water exercise, a response termed postexercise hypotension (PEH). We will assess PEH after a session of water aerobics in physically active, older women with hypertension. Twenty-four women will be randomly assign to participate in a 45 min session of moderate intensity, water aerobics (WATER) and a 45 min land control session (CONTROL). All experimental sessions will start at 9 am sharply with 7 days between them. Subjects will left the experiments wearing an ambulatory BP monitor for the next 21 hr.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90620-001
        • Alexandre Lehnen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • resting SBP ≤ 160 mmHg and DBP ≤ 100 mmHg documented by a physician;
  • 65 to 80 years of age;
  • physically active on land but not water (exercising 3 or more days per week as determined by the International Physical Activity Questionnaire long-form).

Exclusion Criteria:

  • any febrile condition and/or infectious diseases;
  • no other chronic diseases or conditions other than hypertension;
  • body mass index (BMI) > 35 kg/m2;
  • active smoker;
  • physical or mental limitations that prevent exercising.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Water aerobic exercise session (WATER)
A continuous session of dynamic water aerobic exercise which consist of a dynamic warm-up period (5 minutes), an active exercise period (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) will be continuously measured with heart monitors (Polar) to confirm the intensity of the WATER session. The WATER intensity will be calculated according to the formula proposed by Kruel for exercise in an aquatic environment18 as follows: HR for exercise = % x (HRmax - ΔHR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ΔHR represents the difference between resting HR on land and resting HR in the water environment. Exercise intensities: 55-60% HRmax during warm-up; 70-75% HRmax during active exercise; and 55-60% HRmax during cooldown.
Other: Water aerobic exercise session (WATER)
A continuous session of dynamic water aerobic exercise which consist of a dynamic warm-up period (5 minutes), an active exercise period (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) will be continuously measured with heart monitors (Polar) to confirm the intensity of the WATER session. The WATER intensity will be calculated according to the formula proposed by Kruel for exercise in an aquatic environment18 as follows: HR for exercise = % x (HRmax - ΔHR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ΔHR represents the difference between resting HR on land and resting HR in the water environment. Exercise intensities: 55-60% HRmax during warm-up; 70-75% HRmax during active exercise; and 55-60% HRmax during cooldown.
No Intervention: Control session (CONTROL)
A 45-min session with no exercise. During this session, participants will remain seated or standing as desired. They will read, talk, and drink water, but do nothing else.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood pressure measurements
Time Frame: 24-hour ambulatory blood pressure monitoring after water exercise
BP measurements will take and monitored using a 24-hour ambulatory blood pressure monitoring (ABPM) protocol according to standard procedures. BP monitoring devices (Spacelab, Redmond, WA, USA) will be used to obtain BP over 21 hours that consiste of four measurements per hour over awake period (10 am to 10 pm) and two measurements per hour over sleep period (10 pm to 6 am). For data analysis we will calculate hourly averages for awake and sleep (during the same periods as mentioned above), and over 21 hours. SBP and DBP data are presente in two different manners: readings per hour during the day and the night periods, and the BP response determined as the difference (delta) between each hourly BP measurement from baseline after WATER compared to CONTROL.
24-hour ambulatory blood pressure monitoring after water exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Cardiologia do Rio Grande do Sul

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Water Exercise

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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