- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03112070
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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, 90620-001
- Alexandre Lehnen
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-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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
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.
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24-hour ambulatory blood pressure monitoring after water exercise
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 4, 2016
Primary Completion (Actual)
April 30, 2017
Study Completion (Actual)
April 30, 2017
Study Registration Dates
First Submitted
April 3, 2017
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
July 24, 2017
Last Update Submitted That Met QC Criteria
July 20, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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