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.
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
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.
- Conditions
- Hypertension, Blood Pressure
- 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 group | Role | What they receive |
|---|---|---|
| Water aerobic exercise protocol | Experimental | Walter aerobic exercise session would be used to treat blood pressure in elderly hypertensive people. Receives: Other: water aerobic exercise |
| Control Group | No intervention | No exercise intervention would be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted10 Sep 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2020
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centro Universitário de Anapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- After Effects of a Water Aerobics Session on Blood Pressure of Hypertensive Elderly: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04545034
- Acronym / sponsor ID
- PPGMHR-001/20
- Conditions
- Hypertension, Blood Pressure
- Keywords
- hypertension, water aerobic exercise, elderly, blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centro Universitário de AnapolisUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Water aerobic exercise protocol | Experimental | Other: water aerobic exerciseWalter aerobic exercise session would be used to treat blood pressure in elderly hypertensive people. |
| Control Group | No intervention | –No exercise intervention would be used. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water aerobic exerciseThe 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. | Other | Water aerobic exercise protocol |
Primary outcome
Blood pressure after water aerobic exercise in elderly hipertensive
Time frame: Baseline response to 10 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.