Clinical trial NCT03909321: Beach Tennis And Hypertension Study 2
Official title: Effect of Recreational Beach Tennis on Ambulatory Blood Pressure and Physical Fitness in Hypertensive Individuals (BAH Study)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Exercise
Beach Tennis
Sport training
Ambulatory blood pressure monitoring
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2019-04-10
Enrollment: 42
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
measure: Diastolic blood pressure
timeFrame: Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
measure: Cardiorespiratory fitness (Oxygen consumption at peak)
timeFrame: Change from baseline VO2peak at 12 weeks
measure: Muscle strength (Test of hand grip strength)
timeFrame: Change from baseline handgrip at 12 weeks
measure: Muscle strength (Chair-stand test)
timeFrame: Change from baseline Chair-stand test at 12 weeks
measure: Muscle strength (Chair-stand test)
timeFrame: Change from baseline Chair-stand test at 12 weeks
measure: Power muscle
timeFrame: Change from baseline vertical countermovement jump at 12 weeks
measure: Quality of life (WHOQOL-BREF questionnaire)
timeFrame: Change from baseline QoL score at 12 weeks
measure: Enjoyment (PACES questionnaire)
timeFrame: Will be measured during intervention period throughout the first session of weeks 1, 4, 5, 8, 9 and 12.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Rodrigo Ferrari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.