Inactive 30-50-year-old MenNCT07804563
Recreational Football for Young-to-middle-aged Inactive Men
A study testing Experimental: Intervention group in people with Inactive 30-50-year-old Men, run by University of Southern Denmark.
Trial summary
The aim of this study was to examine the health and physical fitness effects of 12 weeks of recreational football in inactive 30-50-year-old men. This was a two-arm, parallel-group randomized controlled trial with a 1:2 allocation ratio to either a control group, which was informed to maintain their inactive… Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inactive 30-50-year-old Men
- What is being tested?
- Experimental: Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Jul 2018
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30-50-year-old-males
- inactive (i.e., not exercising for more than 20 min on three or more days per week)
- with medical clearance from a physician to undertake moderate-to-vigorous intensity exercise
Who cannot join
- Cardiovascular or cerebrovascular disease
- Advanced retinopathy
- Renal failure
- Previous cardiovascular event
About this study
Official title: Euro Football Fitness - Recreational Football as a Broad-spectrum Health Intervention for 30-50-year-old Inactive Men
The aim of this study was to examine the health and physical fitness effects of 12 weeks of recreational football in inactive 30-50-year-old men. This was a two-arm, parallel-group randomized controlled trial with a 1:2 allocation ratio to either a control group, which was informed to maintain their inactive lifestyle, or an intervention group, which completed a 12-week recreational football-based exercise programme. Health and physical fitness assessments were performed at baseline and post-intervention (12 weeks) and selected training sessions throughout the intervention were monitored for internal and external load markers.
Read the detailed description
Randomization:
The participants were randomized 1:2 to the control or the intervention groups, respectively. Randomization was performed by a researcher not involved in data collection or outcome assessment. Blinding of participants and instructors, coaches and the investigation team leading the training sessions was not feasible in this type of exercise intervention. Outcome evaluators, who were not involved in intervention delivery or group allocation, were blinded to group assignment throughout the assessment time points (baseline and 12 weeks).
Statistical analysis:
Both intention-to-treat (ITT) and per-protocol (PP) approaches were applied. The ITT analysis included all randomized participants; missing post-intervention values were handled using multiple imputation. The PP analysis included only participants who attended ≥66% of the prescribed sessions. Descriptive statistics were calculated using observed data and are reported as mean ± SD. The distribution of continuous variables was inspected visually using histograms and Q-Q plots, and normality was further assessed using the Shapiro-Wilk test. Model assumptions were evaluated by visual inspection of residual plots and Q-Q plots of model residuals.
Outcome variables were analysed using linear mixed-effects models to account for repeated measurements within participants. For each outcome, Time (pre vs post), Group (intervention vs control), and the Time × Group interaction were specified as fixed effects, with a participant-specific random intercept to model within-subject clustering, according to the general form: outcome ~ Time + Group + Time × Group + (1 | participant). Fixed effects were evaluated using omnibus F-tests with Satterthwaite-approximated degrees of freedom, and model estimates are reported as regression coefficients (b) with standard errors and 95% confidence intervals. Where appropriate, post hoc pairwise comparisons of estimated marginal means were used to decompose significant effects, with multiplicity controlled using Bonferroni adjustment. Model fit was summarised using marginal and conditional R², and variance components were reported as random-intercept and residual variance. The intraclass correlation coefficient (ICC) was calculated to quantify the proportion of variance attributable to between-participant differences.
Effect sizes were expressed as partial eta squared (ηp²) for omnibus effects and Cohen's d for within- and between-group contrasts, using the standard deviation (SD), not the standard error, as the standardiser to avoid inflation (Lakens, 2013). Cohen's d was interpreted as trivial (<0.20), small (0.20-0.49), moderate (0.50-0.79), and large (≥0.80), following Cohen's conventional thresholds (Cohen, 1988). Partial eta squared was interpreted as small (ηp² ≈ 0.01), moderate (ηp² ≈ 0.06), and large (ηp² ≈ 0.14) (Richardson, 2011). These thresholds were used only as descriptive guidelines, and effects were interpreted alongside the magnitude and precision of the estimated mean differences. All tests were two-sided, with statistical significance set at α = 0.05. Statistical analyses were performed using jamovi (version 2.6.23; The jamovi project, Sydney, Australia) and R packages (R Core Team, R Foundation for Statistical Computing, Vienna, Austria) appropriate for each analysis.
To overcome the common limitation of low statistical power highlighted in previous recreational football interventions, a substantially larger sample size was deliberately recruited. This strategic design choice was undertaken not only to enhance the robustness of subgroup and ITT analyses but also to increase the precision of effect size estimates, thereby improving the generalizability of the findings.
- Conditions
- Inactive 30-50-year-old Men
- Being tested
- Experimental: Intervention group
- Keywords
- Cardiovascular health, Cardio-metabolic and bone blood markers, Body composition, Physical fitness, Recreational team sports
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention groupOther
Also called Recreational football
Participants allocated to the intervention group undertook a 12-week recreational football-based exercise programme performed 2-3 times per week, with each session lasting 60 minutes, under the supervision of sports education graduates and the research team.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Experimental | Participants allocated to the intervention group undertook a 12-week recreational football-based exercise programme performed 2-3 times per week, with each session lasting 60 minutes, under the supervision of sports education graduates and the research team. Receives: Other: Experimental: Intervention group |
| No Intervention: Control group | No intervention | Participants allocated to the control group were informed to maintain their current lifestyle and physical activity habits for the duration of the study. No supervised exercise programme was provided by the research team during the 12-week intervention period. Following the 12-week assessments, the control group participants were offered the opportunity to participate in the recreational football programme. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-groups differences at 12 weeks in maximal oxygen uptake
Maximal oxygen uptake (mL/min/kg) was measured by pulmonary gas exchange measurements. The participants performed an incremental treadmill test until voluntary exhaustion in a laboratory, according to a standardized incremental protocol.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Secondary outcomes (67)
Between-groups differences at 12 weeks in systolic blood pressure
Systolic blood pressure (mmHg) was measured in a laboratory by an automatic upper arm blood pressure monitor (multiparameter patient monitor, Omron Z207, Kyoto, Japan) according to standardized procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in diastolic blood pressure
Diastolic blood pressure (mmHg) was measured using an automatic upper arm blood pressure monitor (multiparameter patient monitor, Omron Z207, Kyoto, Japan) according to standardized procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in resting heart rate
Resting heart rate (bpm) was measured using an automatic upper arm blood pressure monitor (multiparameter patient monitor, Omron Z207, Kyoto, Japan) according to standardized procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body mass
Whole-body mass was measured by a whole-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm total mass
Left arm total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm total mass
Right arm total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg total mass
Left leg total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg total mass
Right leg total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in gynoid total mass
Gynoid total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in android total mass
Android total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body fat mass
Whole-body fat mass was measured by a whole-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm fat mass
Left arm fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm fat mass
Right arm fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg fat mass
Left leg fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg fat mass
Right leg fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in gynoid fat mass
Gynoid fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in android fat mass
Android fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in in whole-body lean mass
Whole-body lean mass was measured by a whole-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm lean mass
Left arm lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm lean mass
Right arm lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg lean mass
Left leg lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg lean mass
Right leg lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body bone mineral density
Whole-body bone mineral density was measured by dual-energy X-ray absorptiometry scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body bone mineral content
Whole-body bone mineral content was measured by dual-energy X-ray absorptiometry scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in lumbar spine bone mineral density
Lumbar spine bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in lumbar spine bone mineral content
Lumbar spine bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in femur bone mineral density
Femur bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in femur bone mineral content
Femur bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm bone mineral density
Left arm mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm bone mineral content
Left arm bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm bone mineral density
Right arm bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm bone mineral content
Right arm mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg bone mineral density
Left leg bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg bone mineral content
Left leg bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg bone mineral density
Right leg bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg bone mineral content
Right leg mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body total T-score
Whole-body total T-score was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body total Z-score
Whole-body total Z-score was measured by dual-energy X-ray absorptiometry regional scans following standard procedures.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in procollagen type-1 amino-terminal propeptide
Plasma concentrations of biochemical bone turnover markers were analysed by chemiluminescence method using a fully automated immunoassay system.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in osteocalcin
Plasma concentrations of biochemical bone turnover markers were analysed by chemiluminescence method using a fully automated immunoassay system.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in carboxy-terminal type-1 collagen crosslinks
Plasma concentrations of biochemical bone turnover markers were analysed by chemiluminescence method using a fully automated immunoassay system.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in postural balance
Postural balance was evaluated by the number of falls in a single-legged flamingo balance test.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in aerobic performance
Aerobic performance (Yo-Yo intermittent endurance level 2 test total distance covered (m)) was evaluated on a football artificial grass pitch, according to a standardized protocol.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in lower body muscle strength
Lower body muscle strength (standing long jump distance (cm)) was evaluated on a football artificial grass pitch, according to a standardized protocol.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in neck circumference
Neck circumference was evaluated according to a standardized protocol.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in waist circumference
Waist circumference was evaluated according to a standardized protocol.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in total cholesterol
Total cholesterol (mg/dl) was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in high-density lipoprotein cholesterol
High-density lipoprotein cholesterol (mg/dl) was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol (mg/dl) was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in triglycerides
Triglycerides (mg/dl) was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in glycosylated haemoglobin
Glycosylated haemoglobin (%) was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in fasting blood glucose
Fasting blood glucose (mg/dl) was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in fasting plasma insulin
Fasting blood insulin (µmol/L) was determined was determined by an automated analyser.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences in physical activity levels
Physical activity levels were measured utilizing the international physical activity questionnaire - short form.
Measured: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Mean and peak relative heart rate
Mean and peak relative heart rate were measured for selected participants in the intervention group during selected training sessions of the exercise programme.
Measured: [Time Frame: 12 weeks]
Mean and peak absolute heart rate
Mean and peak absolute heart rate were measured for selected participants in the intervention group during selected training sessions of the exercise programme.
Measured: [Time Frame: 12 weeks]
Time (absolute and relative) spent in heart rate zones
Time (absolute and relative) spent in heart rate zones were measured for selected participants in the intervention group during selected training sessions of the exercise programme.
Measured: [Time Frame: 12 weeks]
Edwards TRIMP
Edwards TRIMP (AU) was determined for selected participants in the intervention group during selected training sessions of the exercise programme.
Measured: [Time Frame: 12 weeks]
Matches total distance covered
Matches total distance covered was measured for selected participants in the intervention group during selected training sessions matches of the exercise programme
Measured: [Time Frame: 12 weeks]
Match accelerations
Accelerations performed were measured for selected participants in the intervention group during selected training sessions matches of the exercise programme
Measured: [Time Frame: 12 weeks]
Match decelerations
Match decelerations performed were measured for selected participants in the intervention group selected training sessions matches of the exercise programme
Measured: [Time Frame: 12 weeks]
Matches rating of perceived exertion
Rating of perceived exertion was measured for selected participants in the intervention group during selected training sessions matches of the exercise programme
Measured: [Time Frame: 12 weeks]
Fun scores
Fun scores were measured for selected participants in the intervention group during selected training sessions matches of the exercise programme
Measured: [Time Frame: 12 weeks]
Blood lactate
Blood lactate values were measured for selected participants in the intervention group during selected training sessions matches of the exercise programme
Measured: [Time Frame: 12 weeks]
Delayed Onset Muscle Soreness
Delayed Onset Muscle Soreness was measured for selected participants in the intervention group during the exercise programme
Measured: [Time Frame: 12 weeks]
Harms
Harms occurring during the exercise programme were registered.
Measured: [Time Frame: 12 weeks]
Attendance
Number and percentage of scheduled exercise sessions attended by each participant during the exercise programme.
Measured: [Time Frame: 12 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jan 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inactive 30-50-year-old MenStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Football Association, Denmark, University of Maia, Portugal, Research Centre in Physical Activity, Health and Leisure, CIAFEL, Faculty of Sport, University of Porto, Porto, Portugal, Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, Portugal, Faculty of Medicine, University of Porto, Portugal, Football Club of Porto, Portugal
- Responsible party
- Principal investigator, Peter Krustrup, University of Southern Denmark
- Investigators
- Susana Póvoas, PhD, Principal investigator, University of MaiaPeter Krustrup, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804563
- Sponsor's protocol ID
- EURO Football Fitness
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be publicly shared due to confidentiality reasons. Aggregate data supporting the findings of this study may be made available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Euro Football Fitness - Recreational Football as a Broad-spectrum Health Intervention for 30-50-year-old Inactive Men
- ClinicalTrials.gov ID
- NCT07804563
- Acronym / sponsor ID
- EURO Football Fitness
- Conditions
- Inactive 30-50-year-old Men
- Keywords
- Cardiovascular health, Cardio-metabolic and bone blood markers, Body composition, Physical fitness, Recreational team sports
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Football Association, Denmark, University of Maia, Portugal, Research Centre in Physical Activity, Health and Leisure, CIAFEL, Faculty of Sport, University of Porto, Porto, Portugal, Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, Portugal, Faculty of Medicine, University of Porto, Portugal, Football Club of Porto, Portugal
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 4 Sep 2026 (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.
The aim of this study was to examine the health and physical fitness effects of 12 weeks of recreational football in inactive 30-50-year-old men. This was a two-arm, parallel-group randomized controlled trial with a 1:2 allocation ratio to either a control group, which was informed to maintain their inactive lifestyle, or an intervention group, which completed a 12-week recreational football-based exercise programme. Health and physical fitness assessments were performed at baseline and post-intervention (12 weeks) and selected training sessions throughout the intervention were monitored for internal and external load markers.
Detailed description
Randomization:
The participants were randomized 1:2 to the control or the intervention groups, respectively. Randomization was performed by a researcher not involved in data collection or outcome assessment. Blinding of participants and instructors, coaches and the investigation team leading the training sessions was not feasible in this type of exercise intervention. Outcome evaluators, who were not involved in intervention delivery or group allocation, were blinded to group assignment throughout the assessment time points (baseline and 12 weeks).
Statistical analysis:
Both intention-to-treat (ITT) and per-protocol (PP) approaches were applied. The ITT analysis included all randomized participants; missing post-intervention values were handled using multiple imputation. The PP analysis included only participants who attended ≥66% of the prescribed sessions. Descriptive statistics were calculated using observed data and are reported as mean ± SD. The distribution of continuous variables was inspected visually using histograms and Q-Q plots, and normality was further assessed using the Shapiro-Wilk test. Model assumptions were evaluated by visual inspection of residual plots and Q-Q plots of model residuals.
Outcome variables were analysed using linear mixed-effects models to account for repeated measurements within participants. For each outcome, Time (pre vs post), Group (intervention vs control), and the Time × Group interaction were specified as fixed effects, with a participant-specific random intercept to model within-subject clustering, according to the general form: outcome ~ Time + Group + Time × Group + (1 | participant). Fixed effects were evaluated using omnibus F-tests with Satterthwaite-approximated degrees of freedom, and model estimates are reported as regression coefficients (b) with standard errors and 95% confidence intervals. Where appropriate, post hoc pairwise comparisons of estimated marginal means were used to decompose significant effects, with multiplicity controlled using Bonferroni adjustment. Model fit was summarised using marginal and conditional R², and variance components were reported as random-intercept and residual variance. The intraclass correlation coefficient (ICC) was calculated to quantify the proportion of variance attributable to between-participant differences.
Effect sizes were expressed as partial eta squared (ηp²) for omnibus effects and Cohen's d for within- and between-group contrasts, using the standard deviation (SD), not the standard error, as the standardiser to avoid inflation (Lakens, 2013). Cohen's d was interpreted as trivial (<0.20), small (0.20-0.49), moderate (0.50-0.79), and large (≥0.80), following Cohen's conventional thresholds (Cohen, 1988). Partial eta squared was interpreted as small (ηp² ≈ 0.01), moderate (ηp² ≈ 0.06), and large (ηp² ≈ 0.14) (Richardson, 2011). These thresholds were used only as descriptive guidelines, and effects were interpreted alongside the magnitude and precision of the estimated mean differences. All tests were two-sided, with statistical significance set at α = 0.05. Statistical analyses were performed using jamovi (version 2.6.23; The jamovi project, Sydney, Australia) and R packages (R Core Team, R Foundation for Statistical Computing, Vienna, Austria) appropriate for each analysis.
To overcome the common limitation of low statistical power highlighted in previous recreational football interventions, a substantially larger sample size was deliberately recruited. This strategic design choice was undertaken not only to enhance the robustness of subgroup and ITT analyses but also to increase the precision of effect size estimates, thereby improving the generalizability of the findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Other: Experimental: Intervention groupParticipants allocated to the intervention group undertook a 12-week recreational football-based exercise programme performed 2-3 times per week, with each session lasting 60 minutes, under the supervision of sports education graduates and the research team. |
| No Intervention: Control group | No intervention | –Participants allocated to the control group were informed to maintain their current lifestyle and physical activity habits for the duration of the study. No supervised exercise programme was provided by the research team during the 12-week intervention period. Following the 12-week assessments, the control group participants were offered the opportunity to participate in the recreational football programme. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 30-50-year-old-males
- inactive (i.e., not exercising for more than 20 min on three or more days per week)
- with medical clearance from a physician to undertake moderate-to-vigorous intensity exercise
Key exclusion criteria (4 listed)
- Cardiovascular or cerebrovascular disease
- Advanced retinopathy
- Renal failure
- Previous 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 |
|---|---|---|
| Experimental: Intervention groupAlso: Recreational footballParticipants allocated to the intervention group undertook a 12-week recreational football-based exercise programme performed 2-3 times per week, with each session lasting 60 minutes, under the supervision of sports education graduates and the research team. | Other | Experimental: Intervention group |
Primary outcome
Between-groups differences at 12 weeks in maximal oxygen uptake
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Maximal oxygen uptake (mL/min/kg) was measured by pulmonary gas exchange measurements. The participants performed an incremental treadmill test until voluntary exhaustion in a laboratory, according to a standardized incremental protocol.
67 secondary outcomes
Between-groups differences at 12 weeks in systolic blood pressure
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in diastolic blood pressure
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in resting heart rate
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm total mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm total mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg total mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg total mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in gynoid total mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in android total mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in gynoid fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in android fat mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in in whole-body lean mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm lean mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm lean mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg lean mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg lean mass
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in lumbar spine bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in lumbar spine bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in femur bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in femur bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left arm bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right arm bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in left leg bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg bone mineral density
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in right leg bone mineral content
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body total T-score
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in whole-body total Z-score
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in procollagen type-1 amino-terminal propeptide
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
Between-groups differences at 12 weeks in osteocalcin
Time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]
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 4 Sep 2026.
- Individual participant dataSharing planned: No. Participant data will not be publicly shared due to confidentiality reasons. Aggregate data supporting the findings of this study may be made available from the corresponding author upon reasonable request.
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
Peter Krustrup, PhD principal investigator
University of Southern Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention group in people with Inactive 30-50-year-old Men, run by University of Southern Denmark.
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 3 inclusion and 4 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 at 12 weeks in maximal oxygen uptake (time frame: [Time Frame: Baseline and 12 weeks after the beginning of the intervention]). 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 4 Sep 2026.