Inactive 30-50-year-old Men
Conditions
Keywords
Cardiovascular health, Cardio-metabolic and bone blood markers, Body composition, Physical fitness, Recreational team sports
Brief 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 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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* Cardiovascular or cerebrovascular disease * Advanced retinopathy * Renal failure * Previous cardiovascular event
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-groups differences at 12 weeks in maximal oxygen uptake | [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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-groups differences at 12 weeks in left arm bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left arm bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in right arm bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right arm bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in right arm bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right arm mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in android total mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Android total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in whole-body fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body fat mass was measured by a whole-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left arm fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left arm fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in right arm fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right arm fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left leg fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left leg fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in right leg fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right leg fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in gynoid fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Gynoid fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in android fat mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Android fat mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in in whole-body lean mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body lean mass was measured by a whole-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left arm lean mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left arm lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in right arm lean mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right arm lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left leg lean mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left leg lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in right leg lean mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right leg lean mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in whole-body bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body bone mineral density was measured by dual-energy X-ray absorptiometry scans following standard procedures. |
| Between-groups differences at 12 weeks in whole-body bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body bone mineral content was measured by dual-energy X-ray absorptiometry scans following standard procedures. |
| Between-groups differences at 12 weeks in lumbar spine bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Lumbar spine bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in lumbar spine bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Lumbar spine bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in femur bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Femur bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in femur bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Femur bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in left leg bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left leg bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in left leg bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left leg bone mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in right leg bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right leg bone mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in right leg bone mineral content | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right leg mineral content was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in whole-body total T-score | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body total T-score was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in whole-body total Z-score | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body total Z-score was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in procollagen type-1 amino-terminal propeptide | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Plasma concentrations of biochemical bone turnover markers were analysed by chemiluminescence method using a fully automated immunoassay system. |
| Between-groups differences at 12 weeks in osteocalcin | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Plasma concentrations of biochemical bone turnover markers were analysed by chemiluminescence method using a fully automated immunoassay system. |
| Between-groups differences at 12 weeks in carboxy-terminal type-1 collagen crosslinks | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Plasma concentrations of biochemical bone turnover markers were analysed by chemiluminescence method using a fully automated immunoassay system. |
| Between-groups differences at 12 weeks in postural balance | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Postural balance was evaluated by the number of falls in a single-legged flamingo balance test. |
| Between-groups differences at 12 weeks in aerobic performance | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | 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. |
| Between-groups differences at 12 weeks in lower body muscle strength | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Lower body muscle strength (standing long jump distance (cm)) was evaluated on a football artificial grass pitch, according to a standardized protocol. |
| Between-groups differences at 12 weeks in neck circumference | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Neck circumference was evaluated according to a standardized protocol. |
| Between-groups differences at 12 weeks in waist circumference | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Waist circumference was evaluated according to a standardized protocol. |
| Between-groups differences at 12 weeks in total cholesterol | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Total cholesterol (mg/dl) was determined by an automated analyser. |
| Between-groups differences at 12 weeks in high-density lipoprotein cholesterol | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | High-density lipoprotein cholesterol (mg/dl) was determined by an automated analyser. |
| Between-groups differences at 12 weeks in low-density lipoprotein cholesterol | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Low-density lipoprotein cholesterol (mg/dl) was determined by an automated analyser. |
| Between-groups differences at 12 weeks in triglycerides | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Triglycerides (mg/dl) was determined by an automated analyser. |
| Between-groups differences at 12 weeks in glycosylated haemoglobin | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Glycosylated haemoglobin (%) was determined by an automated analyser. |
| Between-groups differences at 12 weeks in fasting blood glucose | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Fasting blood glucose (mg/dl) was determined by an automated analyser. |
| Between-groups differences at 12 weeks in fasting plasma insulin | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Fasting blood insulin (µmol/L) was determined was determined by an automated analyser. |
| Between-groups differences in physical activity levels | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Physical activity levels were measured utilizing the international physical activity questionnaire - short form. |
| Mean and peak relative heart rate | [Time Frame: 12 weeks] | Mean and peak relative heart rate were measured for selected participants in the intervention group during selected training sessions of the exercise programme. |
| Mean and peak absolute heart rate | [Time Frame: 12 weeks] | Mean and peak absolute heart rate were measured for selected participants in the intervention group during selected training sessions of the exercise programme. |
| Time (absolute and relative) spent in heart rate zones | [Time Frame: 12 weeks] | 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. |
| Edwards TRIMP | [Time Frame: 12 weeks] | Edwards TRIMP (AU) was determined for selected participants in the intervention group during selected training sessions of the exercise programme. |
| Matches total distance covered | [Time Frame: 12 weeks] | Matches total distance covered was measured for selected participants in the intervention group during selected training sessions matches of the exercise programme |
| Match accelerations | [Time Frame: 12 weeks] | Accelerations performed were measured for selected participants in the intervention group during selected training sessions matches of the exercise programme |
| Match decelerations | [Time Frame: 12 weeks] | Match decelerations performed were measured for selected participants in the intervention group selected training sessions matches of the exercise programme |
| Matches rating of perceived exertion | [Time Frame: 12 weeks] | Rating of perceived exertion was measured for selected participants in the intervention group during selected training sessions matches of the exercise programme |
| Fun scores | [Time Frame: 12 weeks] | Fun scores were measured for selected participants in the intervention group during selected training sessions matches of the exercise programme |
| Blood lactate | [Time Frame: 12 weeks] | Blood lactate values were measured for selected participants in the intervention group during selected training sessions matches of the exercise programme |
| Delayed Onset Muscle Soreness | [Time Frame: 12 weeks] | Delayed Onset Muscle Soreness was measured for selected participants in the intervention group during the exercise programme |
| Harms | [Time Frame: 12 weeks] | Harms occurring during the exercise programme were registered. |
| Attendance | [Time Frame: 12 weeks] | Number and percentage of scheduled exercise sessions attended by each participant during the exercise programme. |
| Between-groups differences at 12 weeks in systolic blood pressure | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | 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. |
| Between-groups differences at 12 weeks in diastolic blood pressure | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | 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. |
| Between-groups differences at 12 weeks in resting heart rate | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | 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. |
| Between-groups differences at 12 weeks in whole-body mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Whole-body mass was measured by a whole-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left arm total mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left arm total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in right arm total mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right arm total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left leg total mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left leg total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in right leg total mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Right leg total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
| Between-groups differences at 12 weeks in left arm bone mineral density | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Left arm mineral density was measured by dual-energy X-ray absorptiometry regional scans following standard procedures. |
| Between-groups differences at 12 weeks in gynoid total mass | [Time Frame: Baseline and 12 weeks after the beginning of the intervention] | Gynoid total mass was measured by a regional-body dual-energy X-ray absorptiometry following standard procedures. |
Contacts
University of Maia
University of Southern Denmark