Saremi 2013.
Methods |
Study design: single‐centre, parallel‐group randomised controlled trial Duration: 8 weeks Power calculation: yes |
|
Participants |
Number of participants: excluded and analysed (not stated) ‐ randomised: 11 intervention and 11 control PCOS definition: ESHRE/ASRM Baseline characteristics (mean ± SD), intervention versus controls: weight (kg) exercise 69.60 ± 18.16, controls 68.50 ± 9.37; body mass index (BMI) exercise 28.29 ± 5.73, controls 28.40 ± 2.70 Inclusion criteria: irregular periods of less than 21 days or more than 31 days, polycystic ovaries on ultrasound, hyperandrogenism – hirsutism and acne Exclusion criteria: infection, metabolic diseases, cardiovascular, renal and adrenal, and extracranial, liver, thyroid disease; oral contraceptive use and metformin, pregnancy, abnormal prolactin and participation in regular exercise Medication use pre and during the study: OCP metformin excluded pre‐study Groups comparable at study commencement: not stated Participants actively seeking pregnancy at study commencement: no |
|
Interventions | Comparison: a) Intervention: an 8‐week aerobic training programme consisting of aerobic training 3 days per week for 8 weeks, for 40 to 60 minutes each. Each session involved 5 to 7 minutes of warm up, 30 to 50 minutes of main exercises on the treadmill (starting at 40% to 45% of heart rate building up to 60% to 65% of heart rate by the end of the 8th week), finishing with cooling down exercises. b) Control: asked not to do more physical activity than they used to and not to start any physical activity without informing research group Compliance with intervention: not reported |
|
Outcomes |
Measurements: Endocrine: total testosterone Metabolic: HDL‐C, LDL‐C, triglycerides, fasting glucose, fasting insulin Anthropometric: weight, BMI, waist circumference, WHR |
|
Notes |
Location: Iran Funding: University of Arak |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | They were randomly divided into 2 11‐person groups |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) Participant reported outcomes | Low risk | Blinding of participants and study personnel would not have been possible due to the nature of the intervention, however outcomes are biochemical assessments of hormone and triglycerides and unlikely to be influenced by knowledge of group allocation. |
Blinding (performance bias and detection bias) Clinician reported outcomes | Low risk | Not blinded but biochemical outcomes unlikely to be affected by blinding as they are objective measures. |
Blinding (performance bias and detection bias) Objective outcomes | Unclear risk | No details provided of blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Manuscript states that 11 women were allocated to each group with no further details of any attrition. |
Selective reporting (reporting bias) | Low risk | No clinical trial reported but all prespecified outcomes reported. |
Other bias | Unclear risk | Appears free of other sources of bias, based on translation (original article in Persian). |