Walther 2009.
| Methods | Design: cluster randomized controlled trial Theoretical framework: unstated Number of intervention groups: 1 Number of control groups: 2 Follow‐up: immediately post‐intervention | |
| Participants | N (intervention): 109
N (control): 73 Age (mean): 11.1 years Sex: male and female Ethnicity: White |
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| Interventions | Country: Germany Setting: school, unstated if urban or rural Provider: unstated Duration: 1 year Intervention: classes assigned to 1 unit of physical exercise (45 min) with at least 15 min of endurance training per school day. In addition, lessons on healthy lifestyle were included in the regular schedule once monthly for all pupils. 2 additional sixth‐grade classes from a school focusing on competitive sports and physical education were selected to serve as a reference group. Control: according to German standards, 2 units (each 45 min) of physical education per week are mandatory in all schools. The nonrandomized sport students (reference group) received 12 units (45 min per unit) of high‐level endurance exercise training per week and frequently participated in competitive sporting events, thus representing a maximum of physical fitness attainable under reasonable conditions in school‐age children | |
| Outcomes | Mean systolic blood pressure (mmHg) Mean diastolic blood pressure (mmHg) Mean blood cholesterol level (mg/dL) VO2max (mL/kg/minute) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: randomization process not reported |
| Allocation concealment (selection bias) | Low risk | Comment: criterion not applicable because all participants were allocated at 1 point in time following recruitment, so at time of recruitment allocation was not known |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: no information given, likely not done |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: incomplete outcome data was not adequately addressed |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes identified a priori were reported on |
| Confounders controlled? | High risk | Comment: not all relevant confounders controlled for |
| Data collection methods valid and reliable? | Low risk | Comment: data collection methods were reported to be valid and reliable |