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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03112070
Other study ID # Water Exercise
Secondary ID
Status Completed
Phase N/A
First received April 3, 2017
Last updated July 20, 2017
Start date April 4, 2016
Est. completion date April 30, 2017

Study information

Verified date July 2017
Source Instituto de Cardiologia do Rio Grande do Sul
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 30, 2017
Est. primary completion date April 30, 2017
Accepts healthy volunteers No
Gender Female
Age group 65 Years to 80 Years
Eligibility 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 Design


Intervention

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 - ?HR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ?HR 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.

Locations

Country Name City State
Brazil Alexandre Lehnen Porto Alegre Rio Grande do Sul

Sponsors (1)

Lead Sponsor Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure measurements 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
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