Hypertension,EssentialHyperFutNCT05185297
Recreational Futsal for Controlled Hypertension
A study testing Recreational Futsal in people with Hypertension,Essential and Hypertension, run by University Institute of Maia at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, men only
- Conditions the study is for
- Hypertension,Essential, Hypertension, Blood Pressure Disorders
- What is being tested?
- Recreational Futsal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 17 Nov 2021to 19 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Cardiovascular disease (heart failure), cerebrovascular disease, advanced retinopathy or kidney failure;
- Resistant hypertension;
- History of cardiovascular event.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial
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.
Read more
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).
Read the 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.
- Being tested
- Recreational Futsal
- Keywords
- futsal, controlled hypertension, recreational futsal, soccer, football
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recreational FutsalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Participants will continue with standard care provided by the family physician. |
| Recreational Futsal, plus standard care | Experimental | 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. Receives: Other: Recreational Futsal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (38)
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 3 months
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.
Measured: 4 months
Between-groups differences in total cholesterol
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 3 months
Between-groups differences in total cholesterol
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 4 months
Between-groups differences in high-density lipoprotein cholesterol
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 3 months
Between-groups differences in high-density lipoprotein cholesterol
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 4 months
Between-groups differences in low-density lipoprotein cholesterol
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 3 months
Between-groups differences in low-density lipoprotein cholesterol
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 4 months
Between-groups differences in triglycerides
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 3 months
Between-groups differences in triglycerides
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 4 months
Between-groups differences in glycosylated hemoglobin
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 3 months
Between-groups differences in glycosylated hemoglobin
Will be analysed using standardised methods, using relevant commercial enzymatic test kits.
Measured: 4 months
Between-groups differences in resting heart rate
Number of heart beats per minute, measured by heart rate monitors.
Measured: 3 months
Between-groups differences in resting heart rate
Number of heart beats per minute, measured by heart rate monitors.
Measured: 4months
Between-groups differences in maximum oxygen consumption
Determined by pulmonary gas exchange measurements.
Measured: 3 months
Between-groups differences in maximum oxygen consumption
Determined by pulmonary gas exchange measurements.
Measured: 4 months
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
Number of meters covered.
Measured: 3 months
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
Number of meters covered.
Measured: 4 months
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)
Measured: 3 months
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)
Measured: 4 months
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).
Measured: 3 months
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).
Measured: 4 months
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)
Measured: 3 months
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)
Measured: 4 months
Between-groups differences in lean mass (measured by DEXA in kg)
measured by Dual Energy X-ray Absorptiometry (kg)
Measured: 3 months
Between-groups differences in lean mass (measured by DEXA in kg)
measured by Dual Energy X-ray Absorptiometry (kg)
Measured: 4 months
Between-groups differences in body fat (measured by DEXA in %)
measured by Dual Energy X-ray Absorptiometry (%)
Measured: 3 months
Between-groups differences in body fat (measured by DEXA in %)
measured by Dual Energy X-ray Absorptiometry (%)
Measured: 4 months
Between-groups differences in body mass (measured by DEXA in kg)
measured by Dual Energy X-ray Absorptiometry (kg)
Measured: 3 months
Between-groups differences in body mass (measured by DEXA in kg)
measured by Dual Energy X-ray Absorptiometry (kg)
Measured: 4 months
Between-groups differences in postural balance
measured by a modified Flamingo test
Measured: 3 months
Between-groups differences in postural balance
measured by a modified Flamingo test
Measured: 4 months
Between-groups differences in lower body strength
measured by a counter-movement jump test
Measured: 3 months
Between-groups differences in lower body strength
measured by a counter-movement jump test
Measured: 4 months
Between-groups differences in quality of life
measured by WHOQOL-BREF questionnaire
Measured: 3 months
Between-groups differences in quality of life
measured by WHOQOL-BREF questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start17 Nov 2021
- Primary completion31 Oct 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Institute of Maia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Susana Cristina Araújo Póvoas, University Institute of Maia
- Investigators
- Susana Póvoas, PhD, Principal investigator, University of Maia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185297
- Sponsor's protocol ID
- UMSFRH/BD/143729/2019
- Acronym
- HyperFut
- Status last verified
- Feb 2023
- First submitted
- 20 Dec 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recreational Futsal as a Coadjuvant in Male Adults With Controlled Hypertension - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05185297
- Acronym / sponsor ID
- HyperFut / UMSFRH/BD/143729/2019
- Keywords
- futsal, controlled hypertension, recreational futsal, soccer, football
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Institute of MaiaUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Participants will continue with standard care provided by the family physician. |
| Recreational Futsal, plus standard care | Experimental | Other: Recreational FutsalParticipants will participate in 2-3 weekly one hour sessions of Recreational Futsal, during 3 months, while maintaining standard care provided by the family physician. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Cardiovascular disease (heart failure), cerebrovascular disease, advanced retinopathy or kidney failure;
- Resistant hypertension;
- History of cardiovascular event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recreational FutsalParticipants will participate in 2-3 weekly one hour sessions of Recreational Futsal, during 3 months, while maintaining standard care provided by the family physician. | Other | Recreational Futsal, plus standard care |
Primary outcome
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.
38 secondary outcomes
Between-groups differences in systolic blood pressure
Time frame: 4 months
Between-groups differences in diastolic blood pressure
Time frame: 4 months
Between-groups differences in mean blood pressure
Time frame: 3 months
Between-groups differences in mean blood pressure
Time frame: 4 months
Between-groups differences in total cholesterol
Time frame: 3 months
Between-groups differences in total cholesterol
Time frame: 4 months
Between-groups differences in high-density lipoprotein cholesterol
Time frame: 3 months
Between-groups differences in high-density lipoprotein cholesterol
Time frame: 4 months
Between-groups differences in low-density lipoprotein cholesterol
Time frame: 3 months
Between-groups differences in low-density lipoprotein cholesterol
Time frame: 4 months
Between-groups differences in triglycerides
Time frame: 3 months
Between-groups differences in triglycerides
Time frame: 4 months
Between-groups differences in glycosylated hemoglobin
Time frame: 3 months
Between-groups differences in glycosylated hemoglobin
Time frame: 4 months
Between-groups differences in resting heart rate
Time frame: 3 months
Between-groups differences in resting heart rate
Time frame: 4months
Between-groups differences in maximum oxygen consumption
Time frame: 3 months
Between-groups differences in maximum oxygen consumption
Time frame: 4 months
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
Time frame: 3 months
Between-groups differences in aerobic performance (Yo-Yo Intermittent Endurance Level 1 Test)
Time frame: 4 months
Between-groups differences in body mass index
Time frame: 3 months
Between-groups differences in body mass index
Time frame: 4 months
Between-groups differences in bone density (measured by DEXA in g/cm2)
Time frame: 3 months
Between-groups differences in bone density (measured by DEXA in g/cm2)
Time frame: 4 months
Between-groups differences in bone content (measured by DEXA in grams)
Time frame: 3 months
Between-groups differences in bone content (measured by DEXA in grams)
Time frame: 4 months
Between-groups differences in lean mass (measured by DEXA in kg)
Time frame: 3 months
Between-groups differences in lean mass (measured by DEXA in kg)
Time frame: 4 months
Between-groups differences in body fat (measured by DEXA in %)
Time frame: 3 months
Between-groups differences in body fat (measured by DEXA in %)
Time frame: 4 months
Between-groups differences in body mass (measured by DEXA in kg)
Time frame: 3 months
Between-groups differences in body mass (measured by DEXA in kg)
Time frame: 4 months
Between-groups differences in postural balance
Time frame: 3 months
Between-groups differences in postural balance
Time frame: 4 months
Between-groups differences in lower body strength
Time frame: 3 months
Between-groups differences in lower body strength
Time frame: 4 months
Between-groups differences in quality of life
Time frame: 3 months
Between-groups differences in quality of life
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susana Póvoas, PhD principal investigator
University of Maia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recreational Futsal in people with Hypertension,Essential and Hypertension, run by University Institute of Maia at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-groups differences in systolic blood pressure (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.