NCT05185297

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

December 20, 2021

Last Update Submit

February 3, 2023

Conditions

Keywords

futsalcontrolled hypertensionrecreational futsalsoccerfootball

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (38)

  • Between-groups differences in systolic blood pressure

    4 months

  • Between-groups differences in diastolic blood pressure

    4 months

  • Between-groups differences in mean blood pressure

    3 months

  • Between-groups differences in mean blood pressure

    4 months

  • Between-groups differences in total cholesterol

    3 months

  • +33 more secondary outcomes

Study Arms (2)

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.

Other: Recreational Futsal

Interventions

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.

Recreational Futsal, plus standard care

Eligibility Criteria

Age35 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Cardiovascular disease (heart failure), cerebrovascular disease, advanced retinopathy or kidney failure;
  • Resistant hypertension;
  • History of cardiovascular event.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maia

Maia, Portugal

Location

MeSH Terms

Conditions

Essential HypertensionHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Susana Póvoas, PhD

    University of Maia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blood analysis, maximum oxygen consumption and DEXA scans will have blinded outcome assessors.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 11, 2022

Study Start

November 17, 2021

Primary Completion

October 31, 2022

Study Completion

December 19, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations