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HypertensionNCT04545034

Water Aerobics Session on Blood Pressure of Hypertensive Elderly.

A study testing water aerobic exercise in people with Hypertension and Blood Pressure, run by Centro Universitário de Anapolis at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Hypertension, Blood Pressure
What is being tested?
water aerobic exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesBrazil
Study dates
1 Apr 2020to 30 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites
  • Centro Universitário de Anápolis - UniEVANGÉLICA

    Anápolis, Goiás, 75083-515

  • Raphael Martins Da Cunha

    Goiânia, Goiás, 74275-160

Other trials in Brazil

About this study

Official title: After Effects of a Water Aerobics Session on Blood Pressure of Hypertensive Elderly: a Randomized Clinical Trial

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.

Read the 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.

Being tested
water aerobic exercise
Keywords
hypertension, water aerobic exercise, elderly, blood pressure
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • water aerobic exerciseOther

    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.

Study groups in NCT04545034
Study groupRoleWhat they receive
Water aerobic exercise protocolExperimentalWalter aerobic exercise session would be used to treat blood pressure in elderly hypertensive people.
Receives: Other: water aerobic exercise
Control GroupNo interventionNo exercise intervention would be used.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline response to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2020
  2. Study start1 Apr 2020
  3. Primary completion30 Jul 2020
  4. Study completion30 Jul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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
Single blind
Who is masked
Participant
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545034
Sponsor's protocol ID
PPGMHR-001/20
Status last verified
Sep 2020
First submitted
25 Aug 2020
Last updated
10 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing water aerobic exercise in people with Hypertension and Blood Pressure, run by Centro Universitário de Anapolis at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure after water aerobic exercise in elderly hipertensive (time frame: Baseline response to 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.

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