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      Community based yoga classes for type 2 diabetes: an exploratory randomised controlled trial

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          Abstract

          Background

          Yoga is a popular therapy for diabetes but its efficacy is contested. The aim of this study was to explore the feasibility of researching community based yoga classes in Type 2 diabetes with a view to informing the design of a definitive, multi-centre trial

          Methods

          The study design was an exploratory randomised controlled trial with in-depth process evaluation. The setting was two multi-ethnic boroughs in London, UK; one with average and one with low mean socio-economic deprivation score. Classes were held at a sports centre or GP surgery. Participants were 59 people with Type 2 diabetes not taking insulin, recruited from general practice lists or opportunistically by general practice staff. The intervention group were offered 12 weeks of a twice-weekly 90-minute yoga class; the control group was a waiting list for the yoga classes. Both groups received advice and leaflets on healthy lifestyle and were encouraged to exercise.

          Primary outcome measure was HbA1c. Secondary outcome measures included attendance, weight, waist circumference, lipid levels, blood pressure, UKPDS cardiovascular risk score, diabetes-related quality of life (ADDQoL), and self-efficacy. Process measures were attendance at yoga sessions, self-reported frequency of practice between taught sessions, and qualitative data (interviews with patients and therapists, ethnographic observation of the yoga classes, and analysis of documents including minutes of meetings, correspondence, and exercise plans).

          Results

          Despite broad inclusion criteria, around two-thirds of the patients on GP diabetic registers proved ineligible, and 90% of the remainder declined to participate. Mean age of participants was 60 +/- 10 years. Attendance at yoga classes was around 50%. Nobody did the exercises regularly at home. Yoga teachers felt that most participants were unsuitable for 'standard' yoga exercises because of limited flexibility, lack of basic fitness, co-morbidity, and lack of confidence. There was a small fall in HbA1c in the yoga group which was not statistically significant and which was not sustained six months later, and no significant change in other outcome measures.

          Conclusion

          The benefits of yoga in type 2 diabetes suggested in some previous studies were not confirmed. Possible explanations (apart from lack of efficacy) include recruitment challenges; practical and motivational barriers to class attendance; physical and motivational barriers to engaging in the exercises; inadequate intensity and/or duration of yoga intervention; and insufficient personalisation of exercises to individual needs. All these factors should be considered when designing future trials.

          Trial registration

          National Research Register (1410) and Current Controlled Trials (ISRCTN63637211).

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          Most cited references26

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          The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56).

          A definitive model for predicting absolute risk of coronary heart disease (CHD) in male and female people with Type II diabetes is not yet available. This paper provides an equation for estimating the risk of new CHD events in people with Type II diabetes, based on data from 4540 U.K. Prospective Diabetes Study male and female patients. Unlike previously published risk equations, the model is diabetes-specific and incorporates glycaemia, systolic blood pressure and lipid levels as risk factors, in addition to age, sex, ethnic group, smoking status and time since diagnosis of diabetes. All variables included in the final model were statistically significant (P<0.001, except smoking for which P=0.0013) in likelihood ratio testing. This model provides the estimates of CHD risk required by current guidelines for the primary prevention of CHD in Type II diabetes.
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            Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey.

            To assess the sensitivity to within person change over time of an outcome measure for practitioners in primary care that is applicable to a wide range of illness. Comparison of a new patient generated instrument, the measure yourself medical outcome profile (MYMOP), with the SF-36 health profile and a five point change score; all scales were completed during the consultation with' practitioners and repeated after four weeks. 103 patients were followed up for 16 weeks and their results charted; seven practitioners were interviewed. Established practice of the four NHS general practitioners and four of the private complementary practitioners working in one medical centre. Systematic sample of 218 patients from general practice and all 47 patients of complementary practitioners; patients had had symptoms for more than seven days. Standardised response mean and index of responsiveness; view of practitioners. The index of responsiveness, relating to the minimal clinically important difference, was high for MYMOP: 1.4 for the first symptom, 1.33 for activity, and 0.85 for the profile compared with < 0.45 for SF-36. MYMOP's validity was supported by significant correlation between the change score and the change in the MYMOP score and the ability of this instrument to detect more improvement in acute than in chronic conditions. Practitioners found that MYMOP was practical and applicable to all patients with symptoms and that its use increased their awareness of patients' priorities. MYMOP shows promise as an outcome measure for primary care and for complementary treatment. It is more sensitive to change than the SF-36 and has the added bonus of improving patient-practitioner communication.
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              The psychometric properties of the diabetes management self-efficacy scale for patients with type 2 diabetes mellitus.

              This article summarizes the development and validation of a scale to measure the level of self-efficacy of patients with type 2 diabetes mellitus. Self-efficacy is described as people's belief in their capability to organize and execute the course of action required to deal with prospective situations. This self-efficacy scale was developed based on the self-care activities these patients have to carry out in order to manage their diabetes. The following psychometric properties of this scale were established: content validity, construct validity, internal consistency and stability. The original scale contained 42 items. A panel of five experts in diabetes and four self-efficacy experts evaluated the original scale two times for relevance and clarity. This content validity procedure resulted in a final scale which consisted of 20 items. Subsequently, patients with type 2 diabetes were asked to complete this 20-item scale and further tests were done with the 94 usable responses. Factor analysis identified four factors, all of which were related to clusters of self-care activities used to manage diabetes which comprised this scale. The internal consistency of the total scale was alpha=0.81 and the test-retest reliability with a 5-week time interval was r=0.79 (P < 0.001).
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                Author and article information

                Journal
                BMC Health Serv Res
                BMC Health Services Research
                BioMed Central
                1472-6963
                2009
                19 February 2009
                : 9
                : 33
                Affiliations
                [1 ]Research Department of Primary Care and Population Health, University College London, London, N19 5LW, UK
                Article
                1472-6963-9-33
                10.1186/1472-6963-9-33
                2652459
                19228402
                3d256685-1972-4aa9-9759-fac8a4a65dd2
                Copyright © 2009 Skoro-Kondza et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 28 August 2008
                : 19 February 2009
                Categories
                Research Article

                Health & Social care
                Health & Social care

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