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Completed

NCT Number: NCT05185297

Recreational Futsal for Controlled Hypertension

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).

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Key information

Conditions

Hypertension,Essential Blood Pressure Blood Pressure Disorders Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

35 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Maia

Maia, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recreational Futsal

Other

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.

Primary outcomes

  1. 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.

  2. 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

  1. Between-groups differences in systolic blood pressure

    Time frame: 4 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.

  2. Between-groups differences in diastolic blood pressure

    Time frame: 4 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.

  3. Between-groups differences in mean blood pressure

    Time frame: 3 months

    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. Between-groups differences in mean blood pressure

    Time frame: 4 months

    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.

  5. Between-groups differences in total cholesterol

    Time frame: 3 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  6. Between-groups differences in total cholesterol

    Time frame: 4 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  7. Between-groups differences in high-density lipoprotein cholesterol

    Time frame: 3 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  8. Between-groups differences in high-density lipoprotein cholesterol

    Time frame: 4 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  9. Between-groups differences in low-density lipoprotein cholesterol

    Time frame: 3 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  10. Between-groups differences in low-density lipoprotein cholesterol

    Time frame: 4 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  11. Between-groups differences in triglycerides

    Time frame: 3 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  12. Between-groups differences in triglycerides

    Time frame: 4 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  13. Between-groups differences in glycosylated hemoglobin

    Time frame: 3 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  14. Between-groups differences in glycosylated hemoglobin

    Time frame: 4 months

    Will be analysed using standardised methods, using relevant commercial enzymatic test kits.

  15. Between-groups differences in resting heart rate

    Time frame: 3 months

    Number of heart beats per minute, measured by heart rate monitors.

  16. Between-groups differences in resting heart rate

    Time frame: 4months

    Number of heart beats per minute, measured by heart rate monitors.

  17. Between-groups differences in maximum oxygen consumption

    Time frame: 3 months

    Determined by pulmonary gas exchange measurements.

  18. Between-groups differences in maximum oxygen consumption

    Time frame: 4 months

    Determined by pulmonary gas exchange measurements.

  19. Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)

    Time frame: 3 months

    Number of meters covered.

  20. Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)

    Time frame: 4 months

    Number of meters covered.

  21. Between-groups differences in body mass index

    Time frame: 3 months

    Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2)

  22. Between-groups differences in body mass index

    Time frame: 4 months

    Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2)

  23. Between-groups differences in bone density (measured by DEXA in g/cm2)

    Time frame: 3 months

    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).

  24. Between-groups differences in bone density (measured by DEXA in g/cm2)

    Time frame: 4 months

    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).

  25. Between-groups differences in bone content (measured by DEXA in grams)

    Time frame: 3 months

    bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams)

  26. Between-groups differences in bone content (measured by DEXA in grams)

    Time frame: 4 months

    bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams)

  27. Between-groups differences in lean mass (measured by DEXA in kg)

    Time frame: 3 months

    measured by Dual Energy X-ray Absorptiometry (kg)

  28. Between-groups differences in lean mass (measured by DEXA in kg)

    Time frame: 4 months

    measured by Dual Energy X-ray Absorptiometry (kg)

  29. Between-groups differences in body fat (measured by DEXA in %)

    Time frame: 3 months

    measured by Dual Energy X-ray Absorptiometry (%)

  30. Between-groups differences in body fat (measured by DEXA in %)

    Time frame: 4 months

    measured by Dual Energy X-ray Absorptiometry (%)

  31. Between-groups differences in body mass (measured by DEXA in kg)

    Time frame: 3 months

    measured by Dual Energy X-ray Absorptiometry (kg)

  32. Between-groups differences in body mass (measured by DEXA in kg)

    Time frame: 4 months

    measured by Dual Energy X-ray Absorptiometry (kg)

  33. Between-groups differences in postural balance

    Time frame: 3 months

    measured by a modified Flamingo test

  34. Between-groups differences in postural balance

    Time frame: 4 months

    measured by a modified Flamingo test

  35. Between-groups differences in lower body strength

    Time frame: 3 months

    measured by a counter-movement jump test

  36. Between-groups differences in lower body strength

    Time frame: 4 months

    measured by a counter-movement jump test

  37. Between-groups differences in quality of life

    Time frame: 3 months

    measured by WHOQOL-BREF questionnaire

  38. Between-groups differences in quality of life

    Time frame: 4 months

    measured by WHOQOL-BREF questionnaire

Sponsors and collaborators

Lead sponsor

University Institute of Maia

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

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

Acronym: HyperFut

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2022
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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