Beach Tennis And Hypertension Study 2 (BAH)
Primary Purpose
Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Beach tennis training group
Sponsored by

About this trial
This is an interventional treatment trial for Hypertension focused on measuring Exercise, Beach Tennis, Sport training, Ambulatory blood pressure monitoring
Eligibility Criteria
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.
Sites / Locations
- Hospital de Clinicas de Porto AlegreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Beach tennis training group
Arm Description
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.
The Beach Tennis (BT) group will perform two sessions per week of the Beach Tennis training. This intervention will last 12 weeks.
Outcomes
Primary Outcome Measures
Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device
Secondary Outcome Measures
Systolic blood pressure
Systolic blood pressure in mmHg measured using automatic oscillometric device
Diastolic blood pressure
Diastolic blood pressure in mmHg measured using automatic oscillometric device
Cardiorespiratory fitness (Oxygen consumption at peak)
Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
Muscle strength (Test of hand grip strength)
Performs palmar grip with the greatest possible force
Muscle strength (Chair-stand test)
The total number of stands executed correctly within 30-s
Muscle strength (Chair-stand test)
The time to perform the first five stands executed correctly
Power muscle
Vertical countermovement jump tests
Quality of life (WHOQOL-BREF questionnaire)
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.
Enjoyment (PACES questionnaire)
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".
Full Information
NCT ID
NCT03909321
First Posted
April 8, 2019
Last Updated
February 7, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03909321
Brief Title
Beach Tennis And Hypertension Study 2
Acronym
BAH
Official Title
Effect of Recreational Beach Tennis on Ambulatory Blood Pressure and Physical Fitness in Hypertensive Individuals (BAH Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
No studies have investigated the chronic effects of team sports on 24 h ambulatory blood pressure and have assessed the effects of a beach tennis intervention in cardiovascular profile and physical fitness. Based on that, the investigators designed this parallel randomized controlled trial to evaluate the effect of beach tennis training on 24 h ambulatory blood pressure and different physical fitness parameters in individuals with hypertension. The difference between the intervention arms in mean change from baseline in 24 h, daytime and nighttime systolic and diastolic ambulatory blood pressure at 12-weeks is the primary outcome; secondary outcomes are the difference between mean change in office blood pressure as well as cardiorespiratory fitness, muscular strength and power. The investigators anticipate that 12 weeks of beach tennis training will reduce blood pressure when compared to a non-exercising control group. Additionally, our recreational beach tennis intervention will improve all physical fitness components in comparison to the baseline values.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Exercise, Beach Tennis, Sport training, Ambulatory blood pressure monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Beach tennis training group
Arm Type
Experimental
Arm Description
The Beach Tennis (BT) group will perform two sessions per week of the Beach Tennis training. This intervention will last 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Beach tennis training group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ambulatory Blood Pressure
Description
24h ambulatory blood pressure measured through automatic oscillometric device
Time Frame
Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure in mmHg measured using automatic oscillometric device
Time Frame
Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
Title
Diastolic blood pressure
Description
Diastolic blood pressure in mmHg measured using automatic oscillometric device
Time Frame
Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
Title
Cardiorespiratory fitness (Oxygen consumption at peak)
Description
Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
Time Frame
Change from baseline VO2peak at 12 weeks
Title
Muscle strength (Test of hand grip strength)
Description
Performs palmar grip with the greatest possible force
Time Frame
Change from baseline handgrip at 12 weeks
Title
Muscle strength (Chair-stand test)
Description
The total number of stands executed correctly within 30-s
Time Frame
Change from baseline Chair-stand test at 12 weeks
Title
Muscle strength (Chair-stand test)
Description
The time to perform the first five stands executed correctly
Time Frame
Change from baseline Chair-stand test at 12 weeks
Title
Power muscle
Description
Vertical countermovement jump tests
Time Frame
Change from baseline vertical countermovement jump at 12 weeks
Title
Quality of life (WHOQOL-BREF questionnaire)
Description
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.
Time Frame
Change from baseline QoL score at 12 weeks
Title
Enjoyment (PACES questionnaire)
Description
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".
Time Frame
Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Ferrari, PhD
Phone
+5551996040583
Email
rod.ferrari84@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Leandro de Oliveira Carpes, MSc
Phone
+5551999012660
Email
leandrocarpes.personal@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ferrari, PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ferrari, PhD
Email
get@hcpa.edu.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33407276
Citation
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.
Results Reference
derived
Learn more about this trial
Beach Tennis And Hypertension Study 2
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