- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03909321
Beach Tennis And Hypertension Study 2 (BAH)
Effect of Recreational Beach Tennis on Ambulatory Blood Pressure and Physical Fitness in Hypertensive Individuals (BAH Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, two-arms, parallel randomized controlled trial with concealed allocation, blinded measurers, with 12 weeks of follow-up analyzed using an intention-to-treat approach.
Participants will be randomly allocated to the beach tennis training intervention (BTT) or to the control group (Con), which will not be submitted to intervention and will be instructed not to engage in any kind of structured physical exercise training and to keep the life activities identified at baseline. The International Physical Activity Questionnaire (IPAQ) will be applied before and after the intervention in order to assess the level of physical activity.
In BTT, supervised beach tennis sessions will be performed two times per week. Each session will be composed of an initial period of 10 min of warm up and technical exercises (i.e., serve, volley, forehand and backhand). After that, 3 games of 10-15 min each (weeks 1-4: 3 × 10 min; weeks 5-8: 3 × 12 min; and weeks 9-12: 3 × 15 min) with an interval of 2 min between each game will be played in pairs (i.e., 2 versus 2). In case of less than 4 participants are able to play at the same time, the games can also be played individually (i.e., 1 versus1). In Con, participants will be advised to not change their daily usual activities and to not participate in any structured physical exercise program during this period.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The Control group will not be submitted to intervention and will be instructed not to engage in any kind of structured physical exercise training and to keep the life activities identified at baseline.
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Experimental: Beach tennis training group
The Beach Tennis (BT) group will perform two sessions per week of the Beach Tennis training.
This intervention will last 12 weeks.
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Beach Tennis Training Group (BTG) will perform two sessions of 40-60 min of beach tennis during 12 weeks.
BT sessions will be composed by a warm up of 5-10 min of BT technical exercises (i.e., serve, volley, forehand and backhand exercises) followed by 3 BT small games of 10-15 min each.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ambulatory Blood Pressure
Time Frame: Change from baseline 24-hour systolic blood pressure at 12 weeks
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24h ambulatory blood pressure measured through automatic oscillometric device
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Change from baseline 24-hour systolic blood pressure at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic blood pressure
Time Frame: Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
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Systolic blood pressure in mmHg measured using automatic oscillometric device
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Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
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Diastolic blood pressure
Time Frame: Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
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Diastolic blood pressure in mmHg measured using automatic oscillometric device
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Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
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Cardiorespiratory fitness (Oxygen consumption at peak)
Time Frame: Change from baseline VO2peak at 12 weeks
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Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
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Change from baseline VO2peak at 12 weeks
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Muscle strength (Test of hand grip strength)
Time Frame: Change from baseline handgrip at 12 weeks
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Performs palmar grip with the greatest possible force
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Change from baseline handgrip at 12 weeks
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Muscle strength (Chair-stand test)
Time Frame: Change from baseline Chair-stand test at 12 weeks
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The total number of stands executed correctly within 30-s
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Change from baseline Chair-stand test at 12 weeks
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Muscle strength (Chair-stand test)
Time Frame: Change from baseline Chair-stand test at 12 weeks
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The time to perform the first five stands executed correctly
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Change from baseline Chair-stand test at 12 weeks
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Power muscle
Time Frame: Change from baseline vertical countermovement jump at 12 weeks
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Vertical countermovement jump tests
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Change from baseline vertical countermovement jump at 12 weeks
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Quality of life (WHOQOL-BREF questionnaire)
Time Frame: Change from baseline QoL score at 12 weeks
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The questionnaire contains 26 questions and is divided into four domains (physical, psychological, social and environmental).
Responses follow a Likert scale (1 to 5, the higher the score the better the quality of life) and the values of each domain will be expressed in percentage values.
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Change from baseline QoL score at 12 weeks
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Enjoyment (PACES questionnaire)
Time Frame: Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
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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".
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Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rodrigo Ferrari, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
General Publications
- Ferrari R, de Oliveira Carpes L, Domingues LB, Jacobsen A, Frank P, Jung N, Santini J, Fuchs SC; BAH Study Group. Effect of recreational beach tennis on ambulatory blood pressure and physical fitness in hypertensive individuals (BAH study): rationale and study protocol. BMC Public Health. 2021 Jan 6;21(1):56. doi: 10.1186/s12889-020-10117-5.
- Ferrari R, de Oliveira Carpes L, Betti Domingues L, Mallmann Schneider V, Leal R, Tanaka H, Jung N; The BAH Study Group. Recreational beach tennis training reduces ambulatory blood pressure in adults with hypertension: a randomized clinical trial. J Hypertens. 2024 Dec 1;42(12):2122-2130. doi: 10.1097/HJH.0000000000003850. Epub 2024 Aug 26.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 96487118000005327b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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