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CompletedNCT03112070Updated Jul 24, 2017

Post-Exercise Hypotension After Water Exercise

An interventional study of Water aerobic exercise session (WATER) in Postexercise Hypotension, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Completed at 1 site in Brazil. Open to female participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2016, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Postexercise Hypotension
03

In context

Post-Exercise Hypotension

22 studies on the registry are indexed under Post-Exercise Hypotension; 2 are open to participants now.

This study's enrollment of 24 is above the median of 21 across 22 interventional studies indexed under Post-Exercise Hypotension.

Browse Post-Exercise Hypotension studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 76 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • any febrile condition and/or infectious diseases;
  • no other chronic diseases or conditions other than hypertension;
  • (BMI) > 35 kg/m2;
  • active smoker;
  • physical or mental limitations that prevent exercising.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • 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.

    Other: Water aerobic exercise session (WATER)

  • 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.

Interventions

  • OtherWater 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24-hour ambulatory blood pressure monitoring after water exercise

07

Study locations

1 site
  • Alexandre Lehnen
    Porto Alegre, Rio Grande do Sul 90620-001, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in Apr 2017, 12 months.

Of 14 interventional studies with no phase under Post-Exercise Hypotension, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 15. This study's 12 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2017
First posted
Apr 13, 2017
StartActual
Apr 4, 2016
Primary completionActual
Apr 30, 2017
CompletionActual
Apr 30, 2017
Last update
Jul 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03112070
Lead sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible party
Sponsor
First posted
Apr 13, 2017
Start date
Apr 4, 2016
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017
Last update
Jul 24, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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