Hale L, Higgs C, Gray A R, Mann J, Mani R, Sullivan T, Terry J, Keen D, Stokes T
Centre of Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, 325 Great King Street, Dunedin 9016, PO Box 56, Dunedin 9054, New Zealand.
Biostatistics Centre, University of Otago, Dunedin, Otago, New Zealand.
EClinicalMedicine. 2022 Mar 25;46:101361. doi: 10.1016/j.eclinm.2022.101361. eCollection 2022 Apr.
Exercise is important in type 2 diabetes (T2D) management. Focussing on Māori and Pacific people and those from deprived circumstances, the Diabetes Community Exercise Programme (DCEP) was developed to engage people with T2D in exercise. We report the evaluation of whether being offered DCEP (plus usual care) was more effective than usual care in improving glycaemic control at 1-year.
A randomised, two-arm, parallel, open-label trial with blinding of outcome assessor and data analyst. Adults (age ≥35 years) with T2D recruited from two New Zealand (NZ) communities were randomised, using opaque sealed envelopes and stratified by centre with random block lengths, to DCEP or usual care. DCEP comprises twice-weekly, two-hour sessions of exercise and education over 12-weeks, followed by a twice-weekly maintenance exercise class. The primary outcome was between-group differences in mean changes of glycated haemoglobin (HbA1c) from baseline to 1-year follow-up with intention-to treat analysis. This trial is registered with the Australian NZ Clinical Trials Registry (ANZCTR): ACTRN12617001624370p and is closed to new participants.
From 2018 - 2019, of 294 people screened, 165 (mean age 63·8, SD16·2 years, 56% female, 78·5% European, 14% Māori, 6% Pacific, 27% most deprived) were baseline evaluated, randomised, and analysed at study end (DCEP = 83, control = 82). Multimorbidity (≥2) and polypharmacy (>5 medications) were high (82%, 69%). We found no statistically significant between-groups differences in HbA1c (mmol/mol) change at 15 months (mean 3% higher in DCEP, 95% CI 2% lower to 8% higher, = 0·23). Twelve-week intervention adherence was good (41% attended >80% available sessions). No adverse events were reported.
DCEP was not effective in improving glycaemic control, possibly due to insufficient exercise intensity. Our attendance demonstrated DCEP's cultural accessibility. DCEP might be good to engage in exercise marginalised people with high Hb1Ac levels, multimorbidity, and high polypharmacy.
Health Research Council of New Zealand.
运动在2型糖尿病（T2D）管理中至关重要。针对毛利人和太平洋岛民以及来自贫困环境的人群，制定了糖尿病社区运动计划（DCEP），以使T2D患者参与运动。我们报告了关于提供DCEP（加常规护理）在改善1年血糖控制方面是否比常规护理更有效的评估。
一项随机、双臂、平行、开放标签试验，对结果评估者和数据分析师进行盲法处理。从两个新西兰社区招募的成年T2D患者（年龄≥35岁），使用不透明密封信封随机分组，并按中心分层，随机区组长度分组，分为DCEP组或常规护理组。DCEP包括为期12周、每周两次、每次两小时的运动和教育课程，之后是每周两次的维持运动课程。主要结局是糖化血红蛋白（HbA1c）从基线到1年随访的平均变化的组间差异，采用意向性分析。该试验已在澳大利亚新西兰临床试验注册中心（ANZCTR）注册：ACTRN12617001624370p，不再招募新参与者。
2018年至2019年，在294名筛查者中，165人（平均年龄63.8岁，标准差16.2岁，56%为女性，78.5%为欧洲人，14%为毛利人，6%为太平洋岛民，27%为最贫困人群）在基线时进行评估、随机分组并在研究结束时进行分析（DCEP组 = 83人，对照组 = 82人）。多种疾病（≥2种）和多种药物治疗（>5种药物）的比例很高（分别为82%、69%）。我们发现15个月时HbA1c（mmol/mol）变化的组间差异无统计学意义（DCEP组平均高3%，95%置信区间为低2%至高8%，P = 0.23）。12周干预的依从性良好（41%的人参加了>80%的可用课程）。未报告不良事件。
DCEP在改善血糖控制方面无效，可能是由于运动强度不足。我们的参与情况表明DCEP在文化上具有可及性。DCEP可能有助于使Hb1Ac水平高、患有多种疾病和多种药物治疗的边缘人群参与运动。
新西兰健康研究委员会。
