Shahabi 2016.
Study characteristics | ||
Methods |
Study design: RCT Funding: Gail and Gerald Oppenheimer Family Foundation and Marcled Foundation Published protocol/trial registration: no |
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Participants | Men and women aged 18–65 years who reported their primary medical complaint as chronic abdominal pain or discomfort and associated bowel habit changes consistent with ROME III criteria for IBS. Number randomised: 35 Age: mean 36.3 (SD 12.8) years % Female: 88.9% SES and ethnicity: education 96.2% attained high school diploma; 40.7% married, 48.2% single Inclusion criteria
Exclusion criteria
Recruitment: flyers in the community, Internet announcements and referrals from University of California, Los Angeles and local physicians Recruitment rate: not reported Region: University of California, Los Angeles, USA |
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Interventions |
Number of experimental conditions: 2; exercise intervention and walking control Number of participants (analysed): intervention: 17; control: 10 Description of intervention: 16 group sessions of yoga offered on a biweekly basis, led by an Iyengar yoga‐certified instructor. Sessions lasted about 60 minutes. At each session, participants alternated between practicing 2 sequences of Iyengar yoga postures. Postures were first demonstrated by the instructor who also discussed the health benefits of each posture. Participants were encouraged to practice select postures at home between sessions. Pictures of the poses provided to help with home practice, and instructors discussed ways of facilitating home practice (e.g. use of cushion as a bolster). Sequences and home practice postures consisted of seated poses, inversions, backbends, twists and restorative supine poses. Postures selected because they were believed to be therapeutic for abdominal symptoms associated with IBS. Senior Iyengar yoga instructors were consulted to select postures, and sequences were approved by Mr Iyengar, the founder of the Iyengar School of Yoga, in India. Because Iyengar yoga emphasises alignment, props including bolsters, chairs, belts and blocks were used to help achieve postures. Duration: 8 weeks Number of contacts: 16 Setting: university Modality: supervised Interventionist: Iyengar yoga‐certified instructor, physical trainers Integrity: senior Iyengar yoga instructors were consulted to select postures, and sequences were approved by the founder of the Iyengar School of yoga, in India. Date of study: not reported Description of control: 16 group sessions of non‐aerobic, moderate paced, outdoor walking led by physical trainers who set the pace and led discussion during each session. Walking sessions were offered on a biweekly basis and lasted about 60 minutes. Discussion during each walking session focused on health benefits of walking and physical activity. |
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Outcomes |
Primary outcomes
Secondary outcomes
Outcome relating to reported adverse events: not reported Outcome assessment time points: 8 weeks – end of intervention; 26 weeks – post‐intervention follow‐up Preplanned subgroup analyses: none Unplanned subgroup analyses: – Lost to follow‐up: 8 (23%) until end of intervention (intervention: 5 (14%); control: 3 (9%)); 15 (43%) at 6‐month follow‐up (intervention: 10 (29%); control: 5 (14%)) Analysis: per‐protocol |
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Notes | No specific MCID stated for any of the measured outcomes. | |
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 was 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 | Unclear risk | Insufficient information. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Rate of attrition was 23% at 8 weeks and 42% at 6 months, with uneven rates between groups and ITT analysis was not performed. |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration to determine whether outcomes reported were preplanned. |
Other bias | Unclear risk | Uneven group sizes; differences in baseline characteristics including baseline bowel habits and current exercise habits. |