Beach Tennis And Hypertension Study 2

Hypertension Clinical Trial

— BAH  

Official title:

Effect of Recreational Beach Tennis on Ambulatory Blood Pressure and Physical Fitness in Hypertensive Individuals (BAH Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03909321
• Other study ID #: 96487118000005327b
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2024
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Beach tennis training group
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Blood Pressure	24h ambulatory blood pressure measured through automatic oscillometric device	Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary	Systolic blood pressure	Systolic blood pressure in mmHg measured using automatic oscillometric device	Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
Secondary	Diastolic blood pressure	Diastolic blood pressure in mmHg measured using automatic oscillometric device	Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
Secondary	Cardiorespiratory fitness (Oxygen consumption at peak)	Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing	Change from baseline VO2peak at 12 weeks
Secondary	Muscle strength (Test of hand grip strength)	Performs palmar grip with the greatest possible force	Change from baseline handgrip at 12 weeks
Secondary	Muscle strength (Chair-stand test)	The total number of stands executed correctly within 30-s	Change from baseline Chair-stand test at 12 weeks
Secondary	Muscle strength (Chair-stand test)	The time to perform the first five stands executed correctly	Change from baseline Chair-stand test at 12 weeks
Secondary	Power muscle	Vertical countermovement jump tests	Change from baseline vertical countermovement jump at 12 weeks
Secondary	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.	Change from baseline QoL score at 12 weeks
Secondary	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".	Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.