Sloan 2013.
Methods | Study design: prospective randomised controlled trial Location, number of centres: information not provided Country: USA Study period: information not provided Methods of analysis: "each participant visited the exercise physiology laboratory before the first experimental test session for screening purposes and to familiarise themselves with the laboratory testing procedures. At this session, participants also provided written informed consent. During this preliminary visit participants underwent the same test procedures that were used during subsequent graded maximal exercise testing except that the graded exercise test protocol was stopped once a participant reached an exercise intensity level corresponding to 75% of her age‐predicted maximal heart rate (HR max = 220 – age) and successfully demonstrated the ability to maintain this level of exercise intensity for 30 minutes without becoming unduly fatigued" Inclusion criteria for participant selection were: "(1) female; (2) 1 to 5 years since cessation of menses; (3) FSH levels > 40 IU/L; (4) not on oestrogen replacement therapy; (5) sedentary, defined as no participation in a regular exercise programme for 2 or more times per week for at least 20 minutes per session or in a participative sport at least twice per week during the preceding 6 months; (6) written clearance from personal primary health care provider to participate in the study; and (7) willingness to accept random assignment" Statistical analysis: "using a 2 sample t test, the differences in the mean EG and CG at baseline on key demographic variables of age, height, weight, body mass index (BMI), FSH and VO₂ max between the 2 groups were evaluated. The distributions of all obtained measures were plotted graphically for visual inspection regarding deviation from normality. The result of the Shapiro‐Wilk Test for Normality indicated that the null hypothesis for normality assumptions of mucosal immune measures could not be rejected. The mucosal immune measures data were analysed using multivariate repeated measures analysis of variance (ANOVA). To compare the difference in outcome variables from the baseline and subsequent measurements, the contrast and profile transformations in repeated‐measures ANOVA were employed. P < 0.05 was considered statistically significant. For simultaneous testing of hypotheses, the Bonferroni method for controlling the overall error rate was used. All statistical analysis was performed using Statistical Analysis System (SAS, version 9.2) software. Values have been shown as means ± standard deviations" |
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Participants | Recruitment means: information not provided Target participants: healthy postmenopausal women N screened: 32 participants N completed: 32 participants Gender F = 32: intervention 16, control 16 Age: 54.1 ± 5.3 years old Baseline details: age, gender, physical activity profile, symptom checklist, health history, immune deficiency, medications |
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Interventions | Setting of intervention: home‐based walking programme Description of intervention: 5 days/week of 30‐minute brisk walking at a prescribed moderate aerobic exercise intensity corresponding to 75% of individual HRmax Delivered by: self‐delivered Intervention period: 16 weeks Co‐interventions: none described |
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Outcomes | Height, weight, BMI, FSH, VO₂ max, VE max, RER max, HR max, SIgA measures, incidence and duration of URTI Follow‐up period: 16 weeks |
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Notes | Study funding: supported by NIH/NINR R01 NR 008024 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The authors mention randomisation, but do not describe the methods used. |
Allocation concealment (selection bias) | Unclear risk | The authors do not describe how participants were allocated. "Following random assignment to the EG or CG ..." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The participants could not be blinded due to the characteristics of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcomes measured by participant self‐report. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | The outcomes prespecified in the methods were reported in the results. |
Other bias | Low risk | The study seems to be free of other sources of bias. |