Fani 2019.
Study characteristics | ||
Methods |
Study design: RCT Funding: Isfahan University of Medical Sciences Published protocol/trial registration: no |
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Participants | 20 women with mild and moderate IBS enrolled in a controlled clinical trial performed at the Musculoskeletal Disorders Research Center of the rehabilitation faculty of Isfahan University of Medical Sciences Number randomised: 20 Age: intervention: mean 29.1 (SD 6.8) years; control: mean 32.7 (SD 10.3) years % Female: 100% SES and ethnicity: unmarried 45%; diploma or higher (educational status) 100% Inclusion criteria
Exclusion criteria
Recruitment: referred to the centre by gastroenterologists from across the city Recruitment rate: not reported Region: Isfahan, Iran |
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Interventions |
Number of experimental conditions: 2; exercise intervention and usual activities control Number of participants (analysed): intervention: 10; control: 10 Description of intervention: treadmill exercises 3 times per week for 6 weeks. Target and maximum heart rate were calculated (target heart rate = 70% maximum heart rate, maximum heart rate = 220 – age). Treadmill used was able to record heart rate by participant placing her hands on treadmill handles. Participants walked at slow speed for 5 minutes to warm‐up. Then increased speed until they reached the target heart rate and maintained it for 20 minutes. Then walked for 5 minutes at slow speed to cool‐down. Treadmill used with supervision of physiotherapist in all sessions. Duration: 6 weeks Number of contacts: 18 Setting: university Modality: supervised Interventionist: physiotherapist Integrity: – Date of study: not reported Description of control: usual daily activities |
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Outcomes |
Primary or secondary not specified Outcome relating to reported adverse events: not reported Outcome assessment time points: 6 weeks – end of intervention Preplanned subgroup analyses: none Unplanned subgroup analyses: – Lost to follow‐up: none Analysis: 0 dropouts, therefore ITT |
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Notes | MCID is not specifically given for any measured outcomes but methods stated clinical severity of IBS symptoms was categorised into mild (40%), moderate (35%) and severe (25%) groups based on a score of 75–175 (mild), 175–300 (moderate) and > 300 (severe) from the IBS‐SSS questionnaire. No reference to severity in the results or discussion. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Group allocation not blinded to participants, clinicians or researchers. However, it was not possible to blind participants and personnel for this intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Group allocation was not blinded to participants, clinicians or researchers. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No reported dropouts. |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration to determine whether outcomes reported were preplanned. |
Other bias | Unclear risk | Insufficient details about baseline characteristics (e.g. other morbidities impacting on outcomes) and no information on covariate analysis. |