Recreational Futsal for Controlled Hypertension

Study Overview
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Brief Summary
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Arterial hypertension (HT) was the leading global contributor for premature deaths in 2015. Its treatment includes medication and lifestyle changes, namely diet and regular exercise, which has shown to have an inverse relationship with arterial HT. Recreational soccer (RS) has proven to be a non-pharmacological treatment for several chronic conditions, including arterial HT, with meaningful decreases on blood pressure (BP). Recreation futsal (RF) is expected to elicit comparable BP changes to RS considering that it imposes similar physical and physiological demands. However, the effects of RF on BP and other cardiovascular markers have not been previously investigated in participants only with controlled arterial HT. Furthermore, acute BP changes and double product elicited by this exercise modality were never described. Therefore, the main purpose of this study is to assess if RF is an effective coadjuvant intervention for BP control in adults with controlled arterial HT. Secondary purposes are: i) to determine the impact of RF on other cardiovascular markers; ii) to describe the acute BP changes and the double product elicited by RF; and iii) to assess the impact of 1 month of detraining on BP and other cardiovascular markers (4 months).

Detailed Description
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Statistical analysis: The efficacy of the intervention will be assessed by comparing the differences between groups at follow-up, adjusted for the outcome baseline values, systolic blood pressure, maximum oxygen consumption and age (ANCOVA). Intention-to-treat approach will be the main analysis. The missing data will be imputed by using multiple linear regression. A per protocol analysis will also be performed (intervention group: attendance of at least 62.5% of the training sessions; control group: participants that did not engage in regular and supervised physical exercise or had an increase in dose or number of antihypertensive medication). The significance level will be set at 5%. Randomization: Stratified by baseline systolic blood pressure and maximum oxygen consumption. Contingency plan: If the recruitment rate is below than expected, potential measures are to include: i) 30-35- and 60-65-year-old participants; ii) participants with pre-hypertension or uncontrolled hypertension.

Official Title
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Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial

Conditions
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Hypertension,Essential, Hypertension, Blood Pressure Disorders, Blood Pressure

Intervention / Treatment
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* Other: Recreational Futsal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medicated controlled hypertension, with habitual SBP below 140 mmHg and DBP below 90 mmHg; Males with 35-60 years; Not being engaged in regular and supervised physical exercise in the last 6 months; Medical clearance; Vaccinated against SARS-COV-2. Exclusion Criteria: Cardiovascular disease (heart failure), cerebrovascular disease, advanced retinopathy or kidney failure; Resistant hypertension; History of cardiovascular event.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>Participants will continue with standard care provided by the family physician. | |
| Experimental: Recreational Futsal, plus standard care<br>Participants will participate in 2-3 weekly one hour sessions of Recreational Futsal, during 3 months, while maintaining standard care provided by the family physician. | Other: Recreational Futsal<br>* Participants will participate in 2-3 weekly one hour sessions of Recreational Futsal, during 3 months, while maintaining standard care provided by the family physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-groups differences in systolic blood pressure | Casual (resting) measures of systolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. | 3 months | 
| Between-groups differences in diastolic blood pressure | Casual (resting) measures of diastolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-groups differences in systolic blood pressure | Casual (resting) measures of systolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. | 4 months | 
| Between-groups differences in diastolic blood pressure | Casual (resting) measures of diastolic blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. | 4 months | 
| Between-groups differences in mean blood pressure | Casual (resting) blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. | 3 months | 
| Between-groups differences in mean blood pressure | Casual (resting) blood pressure (mmHg) will be measured in triplicate over the brachial artery of the non-dominant arm after 5 minutes of quiet rest, with 1 minute of recovery between each measure, using an automated oscillometric sphygmomanometer. | 4 months | 
| Between-groups differences in total cholesterol | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 3 months | 
| Between-groups differences in total cholesterol | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 4 months | 
| Between-groups differences in high-density lipoprotein cholesterol | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 3 months | 
| Between-groups differences in high-density lipoprotein cholesterol | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 4 months | 
| Between-groups differences in low-density lipoprotein cholesterol | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 3 months | 
| Between-groups differences in low-density lipoprotein cholesterol | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 4 months | 
| Between-groups differences in triglycerides | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 3 months | 
| Between-groups differences in triglycerides | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 4 months | 
| Between-groups differences in glycosylated hemoglobin | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 3 months | 
| Between-groups differences in glycosylated hemoglobin | Will be analysed using standardised methods, using relevant commercial enzymatic test kits. | 4 months | 
| Between-groups differences in resting heart rate | Number of heart beats per minute, measured by heart rate monitors. | 3 months | 
| Between-groups differences in resting heart rate | Number of heart beats per minute, measured by heart rate monitors. | 4months | 
| Between-groups differences in maximum oxygen consumption | Determined by pulmonary gas exchange measurements. | 3 months | 
| Between-groups differences in maximum oxygen consumption | Determined by pulmonary gas exchange measurements. | 4 months | 
| Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test) | Number of meters covered. | 3 months | 
| Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test) | Number of meters covered. | 4 months | 
| Between-groups differences in body mass index | Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2) | 3 months | 
| Between-groups differences in body mass index | Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2) | 4 months | 
| Between-groups differences in bone density (measured by DEXA in g/cm2) | bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (g / cm2 - grams of bone mineral content per area or analyzed bone cm2). | 3 months | 
| Between-groups differences in bone density (measured by DEXA in g/cm2) | bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (g / cm2 - grams of bone mineral content per area or analyzed bone cm2). | 4 months | 
| Between-groups differences in bone content (measured by DEXA in grams) | bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams) | 3 months | 
| Between-groups differences in bone content (measured by DEXA in grams) | bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams) | 4 months | 
| Between-groups differences in lean mass (measured by DEXA in kg) | measured by Dual Energy X-ray Absorptiometry (kg) | 3 months | 
| Between-groups differences in lean mass (measured by DEXA in kg) | measured by Dual Energy X-ray Absorptiometry (kg) | 4 months | 
| Between-groups differences in body fat (measured by DEXA in %) | measured by Dual Energy X-ray Absorptiometry (%) | 3 months | 
| Between-groups differences in body fat (measured by DEXA in %) | measured by Dual Energy X-ray Absorptiometry (%) | 4 months | 
| Between-groups differences in body mass (measured by DEXA in kg) | measured by Dual Energy X-ray Absorptiometry (kg) | 3 months | 
| Between-groups differences in body mass (measured by DEXA in kg) | measured by Dual Energy X-ray Absorptiometry (kg) | 4 months | 
| Between-groups differences in postural balance | measured by a modified Flamingo test | 3 months | 
| Between-groups differences in postural balance | measured by a modified Flamingo test | 4 months | 
| Between-groups differences in lower body strength | measured by a counter-movement jump test | 3 months | 
| Between-groups differences in lower body strength | measured by a counter-movement jump test | 4 months | 
| Between-groups differences in quality of life | measured by WHOQOL-BREF questionnaire | 3 months | 
| Between-groups differences in quality of life | measured by WHOQOL-BREF questionnaire | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soccer, football, futsal, controlled hypertension, recreational futsal