Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Between-groups differences in systolic blood pressure
研究概览
简要总结
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).
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blood analysis, maximum oxygen consumption and DEXA scans will have blinded outcome assessors.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Cardiovascular disease (heart failure), cerebrovascular disease, advanced retinopathy or kidney failure;
- •Resistant hypertension;
- •History of cardiovascular event.
研究组 & 干预措施
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.
干预措施: Recreational Futsal (Other)
结局指标
主要结局
Between-groups differences in systolic blood pressure
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Susana Cristina Araújo Póvoas
Associated Professor
University Institute of Maia