ISRCTN59775422
Completed
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 sites104 target enrollmentStarted: June 22, 2007Last updated:
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
- Enrollment
- 104
Overview
Brief Summary
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25559915 [added 20/02/2019]
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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