Clinical trial NCT05185297: Recreational Futsal for Controlled Hypertension
Official title: Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension,Essential
Hypertension
Blood Pressure Disorders
Blood Pressure
Keywords: futsal
controlled hypertension
recreational futsal
soccer
football
Lead sponsor: University Institute of Maia
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2022-01-11
Enrollment: 40
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Between-groups differences in systolic blood pressure
timeFrame: 3 months
measure: Between-groups differences in diastolic blood pressure
timeFrame: 3 months
Secondary outcomes:
measure: Between-groups differences in systolic blood pressure
timeFrame: 4 months
measure: Between-groups differences in diastolic blood pressure
timeFrame: 4 months
measure: Between-groups differences in mean blood pressure
timeFrame: 3 months
measure: Between-groups differences in mean blood pressure
timeFrame: 4 months
measure: Between-groups differences in total cholesterol
timeFrame: 3 months
measure: Between-groups differences in total cholesterol
timeFrame: 4 months
measure: Between-groups differences in high-density lipoprotein cholesterol
timeFrame: 3 months
measure: Between-groups differences in high-density lipoprotein cholesterol
timeFrame: 4 months
measure: Between-groups differences in low-density lipoprotein cholesterol
timeFrame: 3 months
measure: Between-groups differences in low-density lipoprotein cholesterol
timeFrame: 4 months
measure: Between-groups differences in triglycerides
timeFrame: 3 months
measure: Between-groups differences in triglycerides
timeFrame: 4 months
measure: Between-groups differences in glycosylated hemoglobin
timeFrame: 3 months
measure: Between-groups differences in glycosylated hemoglobin
timeFrame: 4 months
measure: Between-groups differences in resting heart rate
timeFrame: 3 months
measure: Between-groups differences in resting heart rate
timeFrame: 4months
measure: Between-groups differences in maximum oxygen consumption
timeFrame: 3 months
measure: Between-groups differences in maximum oxygen consumption
timeFrame: 4 months
measure: Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
timeFrame: 3 months
measure: Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
timeFrame: 4 months
measure: Between-groups differences in body mass index
timeFrame: 3 months
measure: Between-groups differences in body mass index
timeFrame: 4 months
measure: Between-groups differences in bone density (measured by DEXA in g/cm2)
timeFrame: 3 months
measure: Between-groups differences in bone density (measured by DEXA in g/cm2)
timeFrame: 4 months
measure: Between-groups differences in bone content (measured by DEXA in grams)
timeFrame: 3 months
measure: Between-groups differences in bone content (measured by DEXA in grams)
timeFrame: 4 months
measure: Between-groups differences in lean mass (measured by DEXA in kg)
timeFrame: 3 months
measure: Between-groups differences in lean mass (measured by DEXA in kg)
timeFrame: 4 months
measure: Between-groups differences in body fat (measured by DEXA in %)
timeFrame: 3 months
measure: Between-groups differences in body fat (measured by DEXA in %)
timeFrame: 4 months
measure: Between-groups differences in body mass (measured by DEXA in kg)
timeFrame: 3 months
measure: Between-groups differences in body mass (measured by DEXA in kg)
timeFrame: 4 months
measure: Between-groups differences in postural balance
timeFrame: 3 months
measure: Between-groups differences in postural balance
timeFrame: 4 months
measure: Between-groups differences in lower body strength
timeFrame: 3 months
measure: Between-groups differences in lower body strength
timeFrame: 4 months
measure: Between-groups differences in quality of life
timeFrame: 3 months
measure: Between-groups differences in quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University of Maia
Study officials:
affiliation: University of Maia
name: Susana Póvoas, PhD
role: PRINCIPAL_INVESTIGATOR
References: