Beach Tennis And Hypertension Study (BAH)

January 12, 2021 updated by: Hospital de Clinicas de Porto Alegre

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control session
Control session without any exercise. The participants remained in seated rest throughout 45 min.
Experimental: Beach Tennis session
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).
Behavioral: Beach Tennis session
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 hours after control and beach tennis sessions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 45 minutes
Systolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout 45 min.
45 minutes
Diastolic blood pressure
Time Frame: 45 minutes
Diastolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout 45 min.
45 minutes
Blood Pressure Variability
Time Frame: 24 hours
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.
24 hours
Enjoyment (PACES questionnaire)
Time Frame: 5 minutes
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".
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 96487118000005327a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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