HypertensionBAHNCT03909308
Beach Tennis And Hypertension Study
A study testing Beach Tennis session in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of the present study was to evaluate the effect of a beach tennis session on 24-hour ambulatory blood pressure in adults with hypertension. The main hypothesis is that a single session of beach tennis would decrease ambulatory blood pressure compared with a non-exercise control session. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Beach Tennis session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 31 Mar 2020
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
- Non-engaged in structured exercise programs in the last 3 months before the beginning of this study;
- Able to perform the proposed exercises.
Who cannot join
- Underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure;
- Diseases that reduce life expectancy;
- Smokers;
- BMI >39.9 kg/m²;
- Diabetic proliferative retinopathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effects of a Beach Tennis Training Session on Ambulatory Blood Pressure in Hypertensive Individuals: a Randomized Clinical Trial
The purpose of the present study was to evaluate the effect of a beach tennis session on 24-hour ambulatory blood pressure in adults with hypertension. The main hypothesis is that a single session of beach tennis would decrease ambulatory blood pressure compared with a non-exercise control session.
Read the detailed description
In this randomized crossover trial, participants performed randomly assigned two experimental sessions: a beach tennis session and a non-exercise control session. The beach tennis session started with a standardized 5-minute warm-up consisting of basic techniques, followed by three 12-minute beach tennis matches with 2-minute intervals between them. Heart rate and rating of perceived exertion were continuously recorded during the beach tennis session, and enjoyment was measured after the beach tennis session. The control session was performed in seated rest. Both experimental sessions lasted 45 minutes. Ambulatory blood pressure was measured continuously for 24-hour after sessions.
- Conditions
- Hypertension
- Being tested
- Beach Tennis session
- Keywords
- Exercise, Beach Tennis, Sport training, Post exercise hypotension, Ambulatory blood pressure monitoring
- Medical subject headings
- Hypertension, Motor Activity, Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beach Tennis sessionBehavioural
The Beach Tennis training session will be composed by a warm up of 5 min of BT in which technical exercises (i.e., serve, volley, forehand and backhand) will be performed After that, 3 BT small games of 12 min with a 2 minute interval between games using the conventional rules of sport will be performed. Before the session and after each small game, data regarding heart rate, blood pressure and rate perceived exertion will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Control session | No intervention | Control session without any exercise. The participants remained in seated rest throughout 45 min. |
| Beach Tennis session | Experimental | The participants performed a beach tennis training session throughout 45 min.The session started with a standardized 5-minute warm-up consisting of basic techniques (i.e., serve, volley, forehand, and backhand) followed by three 12-minute beach tennis matches with 2-minute intervals between the games. We used regular beach tennis rules in the game, which was played on a regular beach tennis court (i.e., 16 m long by 8 m wide and net 1.70 m high). Receives: Behavioral: Beach Tennis session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure
Day-time, night-time and 24h ambulatory blood pressure measured through automatic oscillometric device after 45 min of control session and beach tennis session
Measured: 24 hours after control and beach tennis sessions
Secondary outcomes (4)
Systolic blood pressure
Systolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout 45 min.
Measured: 45 minutes
Diastolic blood pressure
Diastolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout 45 min.
Measured: 45 minutes
Blood Pressure Variability
Systolic and diastolic BP values obtained in the 24-hour ambulatory blood pressure monitoring, with valid measures included in a programmed software to calculate the average real variability of these measures.
Measured: 24 hours
Enjoyment (PACES questionnaire)
Enjoyment will be measured after beach tennis session, the scale is composed of 18 items in a bipolar affirmations format (i.e., "amused" versus "not-amused") punctuated in a range from the minimum value "1" to the maximum value "7".
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Feb 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Rodrigo Ferrari, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909308
- Sponsor's protocol ID
- 96487118000005327a
- Acronym
- BAH
- Status last verified
- Jan 2021
- First submitted
- 8 Apr 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Domingues LB, Carpes LO, Fuchs SC, Ferrari R. Effects of a single beach tennis session on short-term blood pressure variability in individuals with hypertension: a randomized crossover trial. Blood Press Monit. 2022 Jun 1;27(3):185-191. doi: 10.1097/MBP.0000000000000586. Epub 2022 Mar 7.
PubMed 35258025Carpes L, Jacobsen A, Domingues L, Jung N, Ferrari R. Recreational beach tennis reduces 24-h blood pressure in adults with hypertension: a randomized crossover trial. Eur J Appl Physiol. 2021 May;121(5):1327-1336. doi: 10.1007/s00421-021-04617-4. Epub 2021 Feb 15.
PubMed 33590342
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Beach Tennis Training Session on Ambulatory Blood Pressure in Hypertensive Individuals: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03909308
- Acronym / sponsor ID
- BAH / 96487118000005327a
- Conditions
- Hypertension
- Keywords
- Exercise, Beach Tennis, Sport training, Post exercise hypotension, Ambulatory blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 10 Apr 2019 (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.
The purpose of the present study was to evaluate the effect of a beach tennis session on 24-hour ambulatory blood pressure in adults with hypertension. The main hypothesis is that a single session of beach tennis would decrease ambulatory blood pressure compared with a non-exercise control session.
Detailed description
In this randomized crossover trial, participants performed randomly assigned two experimental sessions: a beach tennis session and a non-exercise control session. The beach tennis session started with a standardized 5-minute warm-up consisting of basic techniques, followed by three 12-minute beach tennis matches with 2-minute intervals between them. Heart rate and rating of perceived exertion were continuously recorded during the beach tennis session, and enjoyment was measured after the beach tennis session. The control session was performed in seated rest. Both experimental sessions lasted 45 minutes. Ambulatory blood pressure was measured continuously for 24-hour after sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control session | No intervention | –Control session without any exercise. The participants remained in seated rest throughout 45 min. |
| Beach Tennis session | Experimental | Behavioral: Beach Tennis sessionThe participants performed a beach tennis training session throughout 45 min.The session started with a standardized 5-minute warm-up consisting of basic techniques (i.e., serve, volley, forehand, and backhand) followed by three 12-minute beach tennis matches with 2-minute intervals between the games. We used regular beach tennis rules in the game, which was played on a regular beach tennis court (i.e., 16 m long by 8 m wide and net 1.70 m high). |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
- Non-engaged in structured exercise programs in the last 3 months before the beginning of this study;
- Able to perform the proposed exercises.
Key exclusion criteria (5 listed)
- Underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure;
- Diseases that reduce life expectancy;
- Smokers;
- BMI >39.9 kg/m²;
- Diabetic proliferative retinopathy.
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 |
|---|---|---|
| Beach Tennis sessionThe Beach Tennis training session will be composed by a warm up of 5 min of BT in which technical exercises (i.e., serve, volley, forehand and backhand) will be performed After that, 3 BT small games of 12 min with a 2 minute interval between games using the conventional rules of sport will be performed. Before the session and after each small game, data regarding heart rate, blood pressure and rate perceived exertion will be recorded. | Behavioural | Beach Tennis session |
Primary outcome
Ambulatory Blood Pressure
Time frame: 24 hours after control and beach tennis sessions
Day-time, night-time and 24h ambulatory blood pressure measured through automatic oscillometric device after 45 min of control session and beach tennis session
4 secondary outcomes
Systolic blood pressure
Time frame: 45 minutes
Diastolic blood pressure
Time frame: 45 minutes
Blood Pressure Variability
Time frame: 24 hours
Enjoyment (PACES questionnaire)
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 35258025Domingues LB, Carpes LO, Fuchs SC, Ferrari R. Effects of a single beach tennis session on short-term blood pressure variability in individuals with hypertension: a randomized crossover trial. Blood Press Monit. 2022 Jun 1;27(3):185-191. doi: 10.1097/MBP.0000000000000586. Epub 2022 Mar 7.
- Derived from this study: PubMed 33590342Carpes L, Jacobsen A, Domingues L, Jung N, Ferrari R. Recreational beach tennis reduces 24-h blood pressure in adults with hypertension: a randomized crossover trial. Eur J Appl Physiol. 2021 May;121(5):1327-1336. doi: 10.1007/s00421-021-04617-4. Epub 2021 Feb 15.
- Individual participant dataSharing planned: Undecided
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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.
Rodrigo Ferrari, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beach Tennis session in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ambulatory Blood Pressure (time frame: 24 hours after control and beach tennis sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03909308, which also lists 2 linked publications.
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 14 Jan 2021.