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Water Aerobics Session on Blood Pressure of Hypertensive Elderly.

Primary Purpose

Hypertension, Blood Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
water aerobic exercise
Sponsored by
Centro Universitário de Anapolis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, water aerobic exercise, elderly, blood pressure

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 65 and 85 years;
  • practice exercise (almost 3 days-week);
  • use of anti-hypertensive drugs;
  • systolic blood pressure (SBP) ≤160 mmHg and diastolic blood pressure (DBP) ≤100 mmHg documented by a physician

Exclusion Criteria:

  • body mass index (BMI) >35 kg/m2;
  • decompensated diabetes mellitus and/or cardiac failure;
  • active smoker;
  • any febrile condition and/or infectious diseases;
  • cardiovascular event in the 3 months preceding the study;
  • hepatopathy;
  • physical or mental limitations that prevent exercising.

Sites / Locations

  • Centro Universitário de Anápolis - UniEVANGÉLICA
  • Raphael Martins Da Cunha

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Water aerobic exercise protocol

Control Group

Arm Description

Walter aerobic exercise session would be used to treat blood pressure in elderly hypertensive people.

No exercise intervention would be used.

Outcomes

Primary Outcome Measures

Blood pressure after water aerobic exercise in elderly hipertensive
Blood pressure was measured with the patient seated using an internationally validated semi-automatic BP monitor (Omron 705-CP, Matsusaka, Japan) following techniques adopted by The Seventh Report [1]. BP was measured before the session (Pre); immediately after (Min-0) and every 10 minutes until 60 minutes after the protocols had been performed (Min-10, Min-20, Min-30, Min-40, Min-50 and Min-60). The measurements were repeated at 2-minute intervals and the calculation of the mean of the two measurements.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
September 3, 2020
Sponsor
Centro Universitário de Anapolis
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1. Study Identification

Unique Protocol Identification Number
NCT04545034
Brief Title
Water Aerobics Session on Blood Pressure of Hypertensive Elderly.
Official Title
After Effects of a Water Aerobics Session on Blood Pressure of Hypertensive Elderly: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Universitário de Anapolis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled trial aimed to determine the subacute blood pressure effects of pharmacologically-treated elderly hypertensive patients after a single session of water aerobic exercise.
Detailed Description
A randomized clinical trial with a crossover design was conducted at an aquatic center and an exercise physiology laboratory. All subjects read and signed an informed consent form before participating in the study. Additionally, this study follows the recommendations as proposed by the CONSORT Statement. The minimum sample size was determined based on a previous study conducted by our research group. We estimated a sample size of 24 individuals for a 5% significance level, power of 95%, and a 10 mmHg difference in systolic blood pressure (SBP). The inclusion criteria were age between 65 and 85 years; practice exercise (almost 3 days-week); use of anti-hypertensive drugs; systolic blood pressure (SBP) ≤160 mmHg and diastolic blood pressure (DBP) ≤100 mmHg documented by a physician. The exclusion criteria were body mass index (BMI) >35 kg/m2; decompensated diabetes mellitus and/or cardiac failure; active smoker; any febrile condition and/or infectious diseases; cardiovascular event in the 3 months preceding the study; hepatopathy; physical or mental limitations that prevent exercising.Participants were recruited using local media advertisement. The potential participants were asked to attend an on-site visit before the experiment. In this visit, the study procedures were explained and they those who agreed to participate signed an informed consent form. Then, they were interviewed using a questionnaire and information on medical history and symptoms among others was collected, and in sequence they underwent physical and medical evaluations with measurements (weight, height, BMI, BP).The included participants were then assigned to either the experimental protocol (EP) or the control protocol (CP) with 48 hours between sessions. Randomization was performed by digital system (www.randomization.org) at a 1:1 allocation ratio and participants were assigned to either exercise or control session. All sessions occurred at the same time (10 to 11 am) with 2 days between sessions. The EP consisted of one water aerobic exercise session carried out at the aquatic center in a 1.4 m-deep swimming pool with water at an average temperature of 28.5°C, with a average air temperature of 30°C. The EP was a continuous session of dynamic water aerobic exercise which consisted of a dynamic warm-up period (5 minutes), an active exercise period at the established intensity of HR (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) was continuously measured with heart monitors (Polar, RS 800 CX®, USA) to confirm the intensity of the exercise. The EP intensity was calculated according to the formula proposed by Kruel et al. (2014) [27] for exercise in an aquatic. Besides, we used the Borg Rating of Perceived Exertion Scale to measure exercise intensity level in those participants on β-blockers, exercising around number 13 of the scale during active exercise. Water aerobic exercises included flexion, extension, abduction, and adduction of upper and lower limbs. It was a continuous session with no rest between.The CP was a 45-min session of no exercise. It was also held at the aquatic center in environment conditions similar to those of the exercise session. During this session, the participants remained seated or standing as desired, and were allowed to read, talk and drink water, but did nothing else. Blood pressure was measured with the patient seated using an internationally validated semi-automatic BP monitor (Omron 705-CP, Matsusaka, Japan) following techniques adopted by The Seventh Report [1]. BP was measured before the session (Pre); immediately after (Min-0) and every 10 minutes until 60 minutes after the protocols had been performed (Min-10, Min-20, Min-30, Min-40, Min-50 and Min-60). The measurements were repeated at 2-minute intervals and the calculation of the mean of the two measurements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure
Keywords
hypertension, water aerobic exercise, elderly, blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a randomized crossover clinical trial carried out with 25 hypertensive women. The study procedures took place over three days with an interval of 48 hours, and included evaluation session, an experimental protocol (EP) and a control protocol (CP).
Masking
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water aerobic exercise protocol
Arm Type
Experimental
Arm Description
Walter aerobic exercise session would be used to treat blood pressure in elderly hypertensive people.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No exercise intervention would be used.
Intervention Type
Other
Intervention Name(s)
water aerobic exercise
Intervention Description
The EP would be formed by continuous session of dynamic water aerobic exercise which consisted of a dynamic warm-up period (5 minutes), an active exercise period at the established intensity of HR (35 minutes), and a cooldown period (5 minutes) to total 45 minutes, with a intensity of 75%HR.
Primary Outcome Measure Information:
Title
Blood pressure after water aerobic exercise in elderly hipertensive
Description
Blood pressure was measured with the patient seated using an internationally validated semi-automatic BP monitor (Omron 705-CP, Matsusaka, Japan) following techniques adopted by The Seventh Report [1]. BP was measured before the session (Pre); immediately after (Min-0) and every 10 minutes until 60 minutes after the protocols had been performed (Min-10, Min-20, Min-30, Min-40, Min-50 and Min-60). The measurements were repeated at 2-minute intervals and the calculation of the mean of the two measurements.
Time Frame
Baseline response to 10 days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 65 and 85 years; practice exercise (almost 3 days-week); use of anti-hypertensive drugs; systolic blood pressure (SBP) ≤160 mmHg and diastolic blood pressure (DBP) ≤100 mmHg documented by a physician Exclusion Criteria: body mass index (BMI) >35 kg/m2; decompensated diabetes mellitus and/or cardiac failure; active smoker; any febrile condition and/or infectious diseases; cardiovascular event in the 3 months preceding the study; hepatopathy; physical or mental limitations that prevent exercising.
Facility Information:
Facility Name
Centro Universitário de Anápolis - UniEVANGÉLICA
City
Anápolis
State/Province
GO
ZIP/Postal Code
75083-515
Country
Brazil
Facility Name
Raphael Martins Da Cunha
City
Goiânia
State/Province
GO
ZIP/Postal Code
74275-160
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Water Aerobics Session on Blood Pressure of Hypertensive Elderly.

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