Skip to main content
. 2022 Jun 29;2022(6):CD011497. doi: 10.1002/14651858.CD011497.pub2

Fani 2019.

Study characteristics
Methods Study design: RCT
Funding: Isfahan University of Medical Sciences
Published protocol/trial registration: no
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
  • Women with mild and moderate IBS

  • Being able to increase the level of physical activity

  • Aged 18–65 years

  • Stable baseline blood pressure


Exclusion criteria
  • Doing aerobic exercises

  • History of rheumatic diseases in lower limb

  • History of metabolic diseases; neurological disorders; cardiovascular problems; and respiratory, renal and lung problems that would prevent them from participating in aerobic exercises

  • History of knee injury or knee surgery during past year

  • History of joint replacement in any of the joints of the lower limb

  • History of fracture in the lower limb during the past 6 months

  • Having clinical symptoms of osteoarthritis in the joints of hip, knee, ankle and foot

  • Major vision disorders

  • Hereditary or acquired musculoskeletal disorders in lower limb

  • Organic GI disorders

  • Using drugs that would affect metabolism or balance

  • Using assistive devices for walking

  • Pregnancy


Recruitment: referred to the centre by gastroenterologists from across the city
Recruitment rate: not reported
Region: Isfahan, Iran
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
Outcomes
  • IBS symptoms (IBS‐SSS)

  • IBS quality of life (IBS‐QOL)


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
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.