Recreational Futsal for Controlled Hypertension

Hypertension Clinical Trial

— HyperFut  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05185297
• Other study ID #: UMSFRH/BD/143729/2019
• Status: Completed
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: December 19, 2022

Study information

• Verified date: February 2023
• Source: University Institute of Maia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 19, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Blood Pressure Disorders
• Essential Hypertension
• Hypertension
• Hypertension,Essential

Intervention

Other:
• Recreational Futsal
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.

Locations

Country	Name	City	State
Portugal	University of Maia	Maia

Sponsors (2)

Lead Sponsor	Collaborator
University Institute of Maia	University of Southern Denmark

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Between-groups differences in total cholesterol	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	3 months
Secondary	Between-groups differences in total cholesterol	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	4 months
Secondary	Between-groups differences in high-density lipoprotein cholesterol	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	3 months
Secondary	Between-groups differences in high-density lipoprotein cholesterol	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	4 months
Secondary	Between-groups differences in low-density lipoprotein cholesterol	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	3 months
Secondary	Between-groups differences in low-density lipoprotein cholesterol	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	4 months
Secondary	Between-groups differences in triglycerides	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	3 months
Secondary	Between-groups differences in triglycerides	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	4 months
Secondary	Between-groups differences in glycosylated hemoglobin	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	3 months
Secondary	Between-groups differences in glycosylated hemoglobin	Will be analysed using standardised methods, using relevant commercial enzymatic test kits.	4 months
Secondary	Between-groups differences in resting heart rate	Number of heart beats per minute, measured by heart rate monitors.	3 months
Secondary	Between-groups differences in resting heart rate	Number of heart beats per minute, measured by heart rate monitors.	4months
Secondary	Between-groups differences in maximum oxygen consumption	Determined by pulmonary gas exchange measurements.	3 months
Secondary	Between-groups differences in maximum oxygen consumption	Determined by pulmonary gas exchange measurements.	4 months
Secondary	Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)	Number of meters covered.	3 months
Secondary	Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)	Number of meters covered.	4 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Between-groups differences in lean mass (measured by DEXA in kg)	measured by Dual Energy X-ray Absorptiometry (kg)	3 months
Secondary	Between-groups differences in lean mass (measured by DEXA in kg)	measured by Dual Energy X-ray Absorptiometry (kg)	4 months
Secondary	Between-groups differences in body fat (measured by DEXA in %)	measured by Dual Energy X-ray Absorptiometry (%)	3 months
Secondary	Between-groups differences in body fat (measured by DEXA in %)	measured by Dual Energy X-ray Absorptiometry (%)	4 months
Secondary	Between-groups differences in body mass (measured by DEXA in kg)	measured by Dual Energy X-ray Absorptiometry (kg)	3 months
Secondary	Between-groups differences in body mass (measured by DEXA in kg)	measured by Dual Energy X-ray Absorptiometry (kg)	4 months
Secondary	Between-groups differences in postural balance	measured by a modified Flamingo test	3 months
Secondary	Between-groups differences in postural balance	measured by a modified Flamingo test	4 months
Secondary	Between-groups differences in lower body strength	measured by a counter-movement jump test	3 months
Secondary	Between-groups differences in lower body strength	measured by a counter-movement jump test	4 months
Secondary	Between-groups differences in quality of life	measured by WHOQOL-BREF questionnaire	3 months
Secondary	Between-groups differences in quality of life	measured by WHOQOL-BREF questionnaire	4 months