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Recreational Futsal for Controlled Hypertension (HyperFut)

Primary Purpose

Hypertension,Essential, Hypertension, Blood Pressure Disorders

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Recreational Futsal
Sponsored by
University Institute of Maia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential focused on measuring futsal, controlled hypertension, recreational futsal, soccer, football

Eligibility Criteria

35 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Maia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Recreational Futsal, plus standard care

Arm Description

Participants will continue with standard care provided by the family physician.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2021
Last Updated
February 3, 2023
Sponsor
University Institute of Maia
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05185297
Brief Title
Recreational Futsal for Controlled Hypertension
Acronym
HyperFut
Official Title
Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Institute of Maia
Collaborators
University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential, Hypertension, Blood Pressure Disorders, Blood Pressure
Keywords
futsal, controlled hypertension, recreational futsal, soccer, football

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blood analysis, maximum oxygen consumption and DEXA scans will have blinded outcome assessors.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants will continue with standard care provided by the family physician.
Arm Title
Recreational Futsal, plus standard care
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Recreational Futsal
Intervention Description
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 Outcome Measure Information:
Title
Between-groups differences in systolic blood pressure
Description
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.
Time Frame
3 months
Title
Between-groups differences in diastolic blood pressure
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Between-groups differences in systolic blood pressure
Description
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.
Time Frame
4 months
Title
Between-groups differences in diastolic blood pressure
Description
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.
Time Frame
4 months
Title
Between-groups differences in mean blood pressure
Description
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.
Time Frame
3 months
Title
Between-groups differences in mean blood pressure
Description
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.
Time Frame
4 months
Title
Between-groups differences in total cholesterol
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
3 months
Title
Between-groups differences in total cholesterol
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
4 months
Title
Between-groups differences in high-density lipoprotein cholesterol
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
3 months
Title
Between-groups differences in high-density lipoprotein cholesterol
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
4 months
Title
Between-groups differences in low-density lipoprotein cholesterol
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
3 months
Title
Between-groups differences in low-density lipoprotein cholesterol
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
4 months
Title
Between-groups differences in triglycerides
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
3 months
Title
Between-groups differences in triglycerides
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
4 months
Title
Between-groups differences in glycosylated hemoglobin
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
3 months
Title
Between-groups differences in glycosylated hemoglobin
Description
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Time Frame
4 months
Title
Between-groups differences in resting heart rate
Description
Number of heart beats per minute, measured by heart rate monitors.
Time Frame
3 months
Title
Between-groups differences in resting heart rate
Description
Number of heart beats per minute, measured by heart rate monitors.
Time Frame
4months
Title
Between-groups differences in maximum oxygen consumption
Description
Determined by pulmonary gas exchange measurements.
Time Frame
3 months
Title
Between-groups differences in maximum oxygen consumption
Description
Determined by pulmonary gas exchange measurements.
Time Frame
4 months
Title
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
Description
Number of meters covered.
Time Frame
3 months
Title
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
Description
Number of meters covered.
Time Frame
4 months
Title
Between-groups differences in body mass index
Description
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2)
Time Frame
3 months
Title
Between-groups differences in body mass index
Description
Defined as a person's weight in kilograms divided by the square of the person's height in metres (kg/m2)
Time Frame
4 months
Title
Between-groups differences in bone density (measured by DEXA in g/cm2)
Description
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).
Time Frame
3 months
Title
Between-groups differences in bone density (measured by DEXA in g/cm2)
Description
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).
Time Frame
4 months
Title
Between-groups differences in bone content (measured by DEXA in grams)
Description
bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams)
Time Frame
3 months
Title
Between-groups differences in bone content (measured by DEXA in grams)
Description
bone density measured by Dual Energy X-ray Absorptiometry. Bone mineral density is expressed as absolute values (grams)
Time Frame
4 months
Title
Between-groups differences in lean mass (measured by DEXA in kg)
Description
measured by Dual Energy X-ray Absorptiometry (kg)
Time Frame
3 months
Title
Between-groups differences in lean mass (measured by DEXA in kg)
Description
measured by Dual Energy X-ray Absorptiometry (kg)
Time Frame
4 months
Title
Between-groups differences in body fat (measured by DEXA in %)
Description
measured by Dual Energy X-ray Absorptiometry (%)
Time Frame
3 months
Title
Between-groups differences in body fat (measured by DEXA in %)
Description
measured by Dual Energy X-ray Absorptiometry (%)
Time Frame
4 months
Title
Between-groups differences in body mass (measured by DEXA in kg)
Description
measured by Dual Energy X-ray Absorptiometry (kg)
Time Frame
3 months
Title
Between-groups differences in body mass (measured by DEXA in kg)
Description
measured by Dual Energy X-ray Absorptiometry (kg)
Time Frame
4 months
Title
Between-groups differences in postural balance
Description
measured by a modified Flamingo test
Time Frame
3 months
Title
Between-groups differences in postural balance
Description
measured by a modified Flamingo test
Time Frame
4 months
Title
Between-groups differences in lower body strength
Description
measured by a counter-movement jump test
Time Frame
3 months
Title
Between-groups differences in lower body strength
Description
measured by a counter-movement jump test
Time Frame
4 months
Title
Between-groups differences in quality of life
Description
measured by WHOQOL-BREF questionnaire
Time Frame
3 months
Title
Between-groups differences in quality of life
Description
measured by WHOQOL-BREF questionnaire
Time Frame
4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana Póvoas, PhD
Organizational Affiliation
University of Maia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maia
City
Maia
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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Recreational Futsal for Controlled Hypertension

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