Recreational Futsal for Controlled Hypertension (HyperFut)

University Institute of Maia

Status: Completed

Conditions: Blood Pressure Disorders; Hypertension,Essential; Hypertension; Blood Pressure

Treatments: Other: Recreational Futsal

Study type: Interventional

Funder types: Other

Identifiers

NCT05185297

UMSFRH/BD/143729/2019

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 40 patients

Sex: Male

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Standard care

No Intervention group

Description:

Participants will continue with standard care provided by the family physician.

Recreational Futsal, plus standard care

Experimental group

Description:

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.

Treatment:

Other: Recreational Futsal