Ordóñez Dios 2019.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: bilingual public schools School exclusion criteria: — Student inclusion criteria: children aged 11 to 12 years in their last year of primary school Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country where trial was performed: Spain |
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| Interventions |
Intervention: two 45‐minute sessions of PE per week plus a daily run (starting at 250 m and progressing to 750 m) Comparator: two 45‐minute sessions of PE per week as stipulated by law Duration of intervention: 12 weeks Duration of follow‐up: 12 weeks Number of schools: 2 Theoretical framework: — |
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| Outcomes | Fitness BMI |
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| Study registration | — | |
| Publication details |
Language of publication: English/Spanish Funding: non‐commercial funding (research funding body) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The objective of this study is to examine the possible effects of a daily physical activity intervention on physical fitness, coordination and attention" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Unclear risk | Comment: number of participants enrolled or randomised not described; only number analysed |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published |
| Cluster RCT ‐ Recruitment bias | Unclear risk | Comment: unclear when baseline data were collected |
| Cluster RCT ‐ Baseline imbalance | Unclear risk | Comment: demographic characteristics not compared |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no loss of clusters |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: clustered nature of data not accounted for in analysis |