Saremi 2016.
Methods |
Study design: 3‐arm, parallel‐group controlled trial Duration: 8 weeks Power calculation: yes. Based on previous studies, estimated sample size to achieve 5 units difference between groups with a power of 0.8, alpha 0.05 was 8 and allowing dropouts, 10 people per group were included |
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Participants |
Number of participants: out of 30 participants in the study, 2 were excluded (1 because of not taking supplement and 1 because of getting sick) PCOS definition: different definition to standard Baseline characteristics (mean ± SD), intervention versus controls: Age: exercise and placebo 25.71 ± 5.1; control 29.81 ± 5.2 Weight: exercise and placebo 65.20 ± 5.3; control 67.4 ± 7.6 BMI: exercise and placebo 24.88 ± 1.23; control 26.02 ± 1.37 Inclusion criteria: at least 3 of the 4 following symptoms: menstrual irregularity, hirsutism, acne and polycystic ovary morphology on the abdominal sonography Exclusion criteria: smoking, infection and taking any medication that could affect laboratory assessments Medication use pre and during the study: taking any medication that could affect laboratory assessments excluded Groups comparable at study commencement: yes, based on numbers above Participants actively seeking pregnancy at study commencement: no |
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Interventions | Comparison: a) Intervention: 1. Resistance exercise with placebo (10 people) 2. Resistance exercise with calcium supplements (10 people) b) Control: maintain their routine lifestyle over the study. Controls reported their diet and physical activity to investigators weekly, over the study period. Compliance with intervention: no information about compliance with exercise and compliance results not reported. To be sure the participants were taking supplements and placebo and to calculate to what extent they were adherent to taking capsules, they were asked to hand over the capsule boxes, then capsules for the next 2 days were given to them. Participants were asked to avoid any change to their usual diet and the dose of capsules. |
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Outcomes |
Measurements: baseline and 8 weeks Reproductive: none Metabolic: glucose, total cholesterol, HDL‐C, LDL‐C, triglycerides and insulin Anthropometric: weight, BMI |
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Notes |
Location: Department of Exercise Physiology, Faculty of Humanities, University of Arak, Arak, Iran Funding: sponsored by the University of Arak |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Abstract states "quasi‐experimental" and that eligible women were randomly assigned to groups, but no further information is provided. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information provided to enable a judgement. |
Blinding (performance bias and detection bias) Participant reported outcomes | Unclear risk | It states that the study was blind but there are no specific details of who was blinded. Presumably the participants due to the use of placebo and calcium supplementation. |
Blinding (performance bias and detection bias) Clinician reported outcomes | Unclear risk | It states that the study was blind but there are no specific details of who was blinded. Presumably the participants due to the use of placebo and calcium supplementation. |
Blinding (performance bias and detection bias) Objective outcomes | Unclear risk | All biochemical outcomes, therefore likely to be low risk. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Out of 30 participants in the study, 2 were excluded (1 because of not taking the supplement and 1 because of getting sick); not sure which group. |
Selective reporting (reporting bias) | Unclear risk | Appears free of selective reporting bias: all pre‐specified outcomes are reported. Difficult to judge based on Google translate of Persian article. |
Other bias | Low risk | At baseline, none of the anthropometric variables was significantly different (P > 0.05) (Table I, II). |