ISRCTN59775422已完成未知
Resistance Exercise in Already-active Diabetic Individuals (READI): a multicentre, two arm, randomised parallel trial
Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute0 个研究点目标入组 104 人开始时间: 2007年6月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 104
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25559915 [added 20/02/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Type one diabetes mellitus as defined by the 2003 Canadian Diabetes Association (CDA) guidelines with duration greater than or equal to one year, requiring insulin therapy starting within one year of diagnosis and continuously thereafter
- •2. Male or female, aged greater than or equal to 16 years, HbA1c 0.066 - 0.099 (normal non-diabetic range 0.040 - 0.060)
- •3. Habitual performance during the previous four months of aerobic exercise greater than or equal to three times per week, including at least 90 minutes per week of vigorous aerobic exercise (of sufficient intensity to cause sweating, e.g., jogging, soccer, basketball, racquet sports), and/or greater than or equal to 150 minutes per week of aerobic exercise of at least moderate intensity (e.g., brisk walking, moderate-paced bicycling) but no resistance training. Subjects must agree to maintain their habitual volume and intensity of aerobic activity during run-in and intervention periods, minimising variation due to seasons, but they will be permitted to vary specific exercises chosen
- •4. Willingness and ability to work closely with the study physicians, nurse and dietician and follow their recommendations for insulin therapy and adjustments of diet
排除标准
- •1. Participation during the previous four months in any resistance training
- •2. Hypoglycaemia unawareness, or severe hypoglycaemia requiring assistance from another person within the previous three months
- •3. Brittle diabetes, characterised by frequent and unpredictable hypoglycaemia (even if not requiring assistance from others) and hyperglycaemia
- •4. Restrictions in physical activity due to disease: intermittent claudication, severe peripheral neuropathy or active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis
- •5. Known or suspected clinically significant gastroparesis
- •6. Body mass index greater than 35 kg/m^2, or weight greater than 147 kg (exceeding capacity of dual energy X-ray absorptiometry [DEXA] or computed tomography [CT] scanners)
- •7. Fasting serum c-peptide greater than or equal to 0.2 nmol/l
- •8. Increase or decrease of greater than or equal to 5% of body weight during the previous two months
- •9. An expected requirement within the subsequent six months for medications (other than insulin) that will affect glucose metabolism (e.g., corticosteroids)
- •10. If age is less than 18 years, linear growth of greater than or equal to 1 cm during the previous year
- •11. Significant renal disease: serum creatinine greater than or equal to 200 mEq/l or proteinuria greater than 1 g/24 hours
- •12. Uncontrolled hypertension: blood pressure (BP) greater than 150 mmHg systolic or greater than 95 mmHg diastolic in a sitting position
- •13. Other illness, judged by the patient or investigators to make participation in this study inadvisable
- •14. Cognitive deficit resulting in inability to understand or comply with instructions
- •15. Pregnancy at the start of the study, or intention to become pregnant in the next year
- •16. Inability to communicate in English or French
- •17. Ischaemic alectrocardiogram (ECG) changes during baseline maximal cardiopulmonary stress test, unless subsequently cleared for participation by a cardiologist after appropriate investigation
- •18. Low aerobic fitness: aerobic fitness more than 15% below the mean for age and gender, based on baseline maximal treadmill exercise test. This criterion is included in order to reduce likelihood of candidates entering the trial by exaggerating their habitual activity. Very few people engaging in regular aerobic activity would have such low treadmill performance
- •19. Unwillingness to sign informed consent
研究者
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