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Post-Exercise Hypotension After Water Exercise

Primary Purpose

Postexercise Hypotension

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Water aerobic exercise session (WATER)
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postexercise Hypotension

Eligibility Criteria

65 Years - 80 Years (Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexandre Lehnen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Water aerobic exercise session (WATER)

Control session (CONTROL)

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2017
Last Updated
July 20, 2017
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03112070
Brief Title
Post-Exercise Hypotension After Water Exercise
Official Title
Post-Exercise Hypotension After Water Exercise in Older Women With Hypertension: A Randomized Crossover Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 4, 2016 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postexercise Hypotension

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Water aerobic exercise session (WATER)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control session (CONTROL)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Water aerobic exercise session (WATER)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure measurements
Description
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.
Time Frame
24-hour ambulatory blood pressure monitoring after water exercise

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Alexandre Lehnen
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90620-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-Exercise Hypotension After Water Exercise

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