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. 2021 Sep 23;2021(9):CD007651. doi: 10.1002/14651858.CD007651.pub3

Dorgo 2009.

Study characteristics
Methods Study design: cluster‐RCT
Participants School inclusion criteria:
School exclusion criteria:
Student inclusion criteria: high school students enrolled in PE classes at selected high schools
Student exclusion criteria: cardiovascular problems, spine deformities, pregnancy
Setting: school
Age group: adolescents
Gender distribution: females and males
Country/Countries where trial was performed: USA
Interventions Intervention 1: PE programme that used manual resistance training in every session. 80‐minute class sessions 3 times/week, plus a 10‐ to 15‐minute warm‐up segment with light cardiovascular activities and dynamic stretching followed by the manual resistance training‐specific segment of approximately 20 to 30 minutes, conducted and supervised by trained research assistants
Intervention 2: manual resistance training PE programme plus a cardiovascular endurance training segment in every session. 80‐minute class sessions, 3 times/week, plus a 20‐ to 30‐minute manual resistance training segment, conducted and supervised by trained research assistants, with an additional 20‐ to 30‐minute period devoted to cardiovascular endurance training. Cardiovascular activities included walking, jogging, step aerobics, and aerobic kickboxing
Comparator: a regular PE programme that followed the usual school curriculum. 80‐minute class sessions. 3 times/week. PE classes focused on skill development for various individual PAs (i.e. bowling, badminton, tennis, table tennis, golf, various track and field events) and team PAs (i.e. soccer, basketball, softball or baseball, volleyball, floor hockey), as well as participation in leisure activities (i.e. hiking) and sport tournaments
Duration of intervention: 18 weeks
Duration of follow‐up: 18 weeks
Number of schools: 3
Theoretical framework: —
Outcomes BMI
Study registration
Publication details Language of publication: English
Funding: non‐commercial funding (National Institutes of Health, National Center on Minority Health and Health Disparities through the Hispanic Health Disparities Research Center, and by Grant Number 5G12RR008124 from National Institutes of Health, Research Centers in Minority Institutions)
Publication status: peer‐reviewed journal
Stated aim for study "The purpose of this study was to document the changes in physical fitness scores and body composition measures of adolescents through the application of manual resistance training and cardiovascular endurance training in school‐based PE settings compared with adolescents attending a traditional PE program"
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: coin flipping [author communication]
Allocation concealment (selection bias) Low risk Comment: all participants were allocated at a single point in time following recruitment, so at time of recruitment, allocation was not known
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comment: no information given; likely not done
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comment: no information given; likely not done
Incomplete outcome data (attrition bias)
Anthropometrics, Fitness High risk Quote from publication: “24 subjects failed to attend the post‐test data collection and were not included in the data analyses” (Dorgo, 2009, p.2291)
Selective reporting (reporting bias) Unclear risk Comment: no protocol published; cannot assess
Cluster RCT ‐ Recruitment bias Low risk Comment: baseline data collected before randomisation
Cluster RCT ‐ Baseline imbalance High risk Comment: baseline differences in some outcomes
Cluster RCT ‐ Loss of clusters High risk Comment: clusters lost to follow‐up
Cluster RCT ‐ Incorrect analysis High risk Comment: no indication clustering was accounted for in analysis