Yang 2011.
Methods | Pilot RCT | |
Participants | Male and female participants were recruited via automated voicemail messages that were delivered to university employees, flyers posted in hospital outpatient waiting rooms and advertisements in local newspapers. 25 participants were randomised to 2 arms: yoga and health education materials Inclusion criteria: between 45 and 65 years old, non‐exercisers for the previous 12 months, have a family history of type 2 diabetes and at least 1 of the following cardio‐metabolic risk factors: impaired fasting glucose, pre‐hypertension, overweight/obese or abnormal level of cholesterol Exclusion criteria: those who were pregnant, used any drug to reduce their blood cholesterol level, BP or glucose, or had a physical disability that would limit their ability to practise yoga 13 participants were randomised to yoga and 12 were randomised to the health education materials (2 male, 21 female; 19 white, 2 black, 1 Hispanic, 1 Native American) Country of publication was the USA |
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Interventions | Participants in both groups were asked to maintain their current activity levels during the intervention Yoga group: 3‐month Vinyasa yoga intervention programme developed and led by a certified yoga instructor who is a PhD certified nurse. Vinyasa yoga is an evolving form of Hatha yoga but Vinyasa is more fitness‐based. The programme included various physical postures and each movement was combined with various breathing patterns. Each 1‐hour session began with a warm‐up (5 to 7 minutes) and ended with a relaxation period (10 minutes). To guide and facilitate home practice participants were provided with a CD of the yoga instructions recorded by the instructor. Group sessions were held twice a week with 2 to 3 days between sessions. There was no certain amount of frequency required Health education materials group: general health education materials mailed to their home every 2 weeks for 3 months. Included content about risk factors for type 2 diabetes and its prevention, tips for healthy eating out, CVD risk factors, consuming a balanced diet and engaging in physical activity Follow‐up period was 3 months |
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Outcomes | Blood pressure and lipid levels | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | High risk | To avoid disappointment with group assignment participants were informed of randomisation when they first contacted the project office for the initial telephone screening |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not stated but it is difficult, if not impossible, to blind participants and personnel to behavioural interventions such as exercise |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Measurements done by staff who were blinded to group assignment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to judge |
Selective reporting (reporting bias) | Low risk | All outcomes stated in methods were reported |
Other bias | Unclear risk | Insufficient information to judge |
BP: blood pressure cART: combination antiretroviral therapy HIV: human immunodeficiency virus ITT: intention‐to‐treat MI: myocardial infarction QoL: quality of life RCT: randomised controlled trial