Effectiveness of a real-life program (DIAfit) to promote physical activity in patients with type 2 diabetes: a pragmatic cluster randomized clinical trial

Introduction The aim of this study was to evaluate the effectiveness a real-life clinical physical activity program (DIAfit) on improving fitness, body composition, and cardiometabolic health in an unselected population with type 2 diabetes mellitus, compare effects two variants different exercise frequencies same outcomes. Research design methods This cluster randomized-controlled assessor-blind trial conducted 11 centres Switzerland. All participants were eligible randomized either standard (3 sessions/week for 12 weeks) or alternative (1 session/week first four weeks, then rest 16 each consisting 36 sessions combined aerobic resistance exercise. Allocation concealed by central office unrelated study. primary outcome fitness. Secondary measures included: BMI, HbA 1c , muscle strength, walking speed, balance, flexibility, blood pressure, lipid profile. Results 185 patients (mean age 59.7 +-10.2 years, 48% women) agreed participate groups: group (n=88) (n=97)). There 11% increase fitness after (12.5 Watts; 95% CI 6.76 18.25; p<0.001). Significant improvements parameters observed at end DIAfit (improvements between 2-29%) except lean mass, triglycerides cholesterol. No differences both programs, larger weight reduction -0.97kg (95% -0.04 -1.91; p=0.04) program. Conclusions Both frequency nation-wide had beneficial pressure negligible. Clinical registration clinicaltrials.gov identifier NCT01289587.