Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Between-groups differences in systolic blood pressure
Study Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Blood analysis, maximum oxygen consumption and DEXA scans will have blinded outcome assessors.
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard care
Participants will continue with standard care provided by the family physician.
Recreational Futsal, plus standard care
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.
Intervention: Recreational Futsal (Other)
Outcomes
Primary Outcomes
Between-groups differences in systolic blood pressure
Time Frame: 3 months
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.
Between-groups differences in diastolic blood pressure
Time Frame: 3 months
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.
Secondary Outcomes
- Between-groups differences in maximum oxygen consumption(4 months)
- Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)(4 months)
- Between-groups differences in diastolic blood pressure(4 months)
- Between-groups differences in bone density (measured by DEXA in g/cm2)(4 months)
- Between-groups differences in mean blood pressure(4 months)
- Between-groups differences in high-density lipoprotein cholesterol(4 months)
- Between-groups differences in triglycerides(4 months)
- Between-groups differences in glycosylated hemoglobin(4 months)
- Between-groups differences in systolic blood pressure(4 months)
- Between-groups differences in total cholesterol(4 months)
- Between-groups differences in low-density lipoprotein cholesterol(4 months)
- Between-groups differences in resting heart rate(4months)
- Between-groups differences in body mass index(4 months)
- Between-groups differences in lean mass (measured by DEXA in kg)(4 months)
- Between-groups differences in lower body strength(4 months)
- Between-groups differences in bone content (measured by DEXA in grams)(4 months)
- Between-groups differences in body fat (measured by DEXA in %)(4 months)
- Between-groups differences in body mass (measured by DEXA in kg)(4 months)
- Between-groups differences in postural balance(4 months)
- Between-groups differences in quality of life(4 months)
- Between-groups differences in mean blood pressure(3 months)
- Between-groups differences in total cholesterol(3 months)
- Between-groups differences in high-density lipoprotein cholesterol(3 months)
- Between-groups differences in low-density lipoprotein cholesterol(3 months)
- Between-groups differences in triglycerides(3 months)
- Between-groups differences in glycosylated hemoglobin(3 months)
- Between-groups differences in resting heart rate(3 months)
- Between-groups differences in maximum oxygen consumption(3 months)
- Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)(3 months)
- Between-groups differences in body mass index(3 months)
- Between-groups differences in bone density (measured by DEXA in g/cm2)(3 months)
- Between-groups differences in bone content (measured by DEXA in grams)(3 months)
- Between-groups differences in lean mass (measured by DEXA in kg)(3 months)
- Between-groups differences in body fat (measured by DEXA in %)(3 months)
- Between-groups differences in body mass (measured by DEXA in kg)(3 months)
- Between-groups differences in postural balance(3 months)
- Between-groups differences in lower body strength(3 months)
- Between-groups differences in quality of life(3 months)
Investigators
Susana Cristina Araújo Póvoas
Associated Professor
University Institute of Maia