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 of a real-life clinical physical activity program (DIAfit) on improving physical fitness, body composition, and cardiometabolic health in an unselected population with type 2 diabetes mellitus, and to compare the effects of two variants a different exercise frequencies on the same outcomes. Research design and methods: This was a cluster randomized-controlled assessor-blind trial conducted in 11 clinical centres in Switzerland. All participants in the clinical program with type 2 diabetes were eligible and were randomized to either standard (3 sessions/week for 12 weeks) or alternative (1 session/week for the first four weeks, then 2 sessions/week for the rest of 16 weeks) physical activity program each consisting of 36 sessions of combined aerobic and resistance exercise. Allocation was concealed by a central office unrelated to the study. The primary outcome was aerobic fitness. Secondary outcome measures included: body composition, BMI, HbA1c, muscle strength, walking speed, balance, flexibility, blood pressure, lipid profile. Results: All 185 patients with type 2 diabetes (mean age 59.7 +-10.2 years, 48% women) agreed to participate and were randomized in two groups: a standard group (n=88) and an alternative group (n=97)). There was an 11% increase in aerobic fitness after the program (12.5 Watts; 95% CI 6.76 to 18.25; p<0.001). Significant improvements in physical fitness, body composition, and cardiometabolic parameters were observed at the end of the DIAfit program (improvements between 2-29%) except for lean body mass, triglycerides and cholesterol. No differences were observed between both programs, except for a larger weight reduction of -0.97kg (95% CI -0.04 to -1.91; p=0.04) in the standard program. Conclusions: Both frequency variants of the nation-wide DIAfit program had beneficial effects on physical fitness, HbA1c, body composition, and blood pressure in type 2 diabetes patients and differences were negligible. Clinical trial registration: clinicaltrials.gov, identifier NCT01289587.

Educational Level Is Related to Physical Fitness in Patients with Type 2 Diabetes - A Cross-Sectional Study.

INTRODUCTION: Low educational level (EL) and low physical fitness are both predictors of increased morbidity and mortality in patients with type 2 diabetes. It is unknown if EL is related to physical fitness. This would have important implication for the treatment approach of patients of low EL. MATERIALS AND METHODS: In 2011/12, we invited participants of a new nationwide Swiss physical activity program for patients with type 2 diabetes to participate in this study. EL was defined by self-report and categorized as low (mandatory education), middle (professional education) or high (high school/university). Physical fitness was determined using 5 validated measures that assessed aerobic fitness, functional lower limb muscle strength, walking speed, balance and flexibility. Potential confounder variables such as other socio-cultural factors, physical activity level, body composition, diabetes-related parameters and complications/co-morbidities as well as well-being were assessed. RESULTS: All invited 185 participants (mean age 59.6 ±9.8 yrs, 76 women) agreed to be included. Of all patients, 23.1% had a low, 32.7% a middle and 44.2% a high EL; 41.8% were professionally active. The study population had a mean BMI of 32.4±5.2 kg/m2 and an HbA1c of 7.3±1.3%. The mean diabetes duration was 8.8±7.4 years. In the baseline assessment, higher EL was associated with increased aerobic fitness, increased functional lower limb muscle strength, and increased walking speed using linear regression analysis (values for low, middle and high EL, respectively: 91.8 ± 27.9, 116.4 ± 49.7 and 134.9 ± 60.4 watts for aerobic fitness (p = 0.002), 15 ± 4.7, 13.9 ± 2.7, 12.6 ± 2.9 seconds for strength (p = 0.001) and 8.8 ± 1.6, 8.3 ± 1.4, 7.8 ± 1.4 seconds for walking speed (p = 0.004)). These associations were independent of potential confounders. Overall, aerobic fitness was 46%, functional limb muscle strength 16%, and walking speed 11% higher in patients of high compared to those of low EL. EL was not related to balance or flexibility. DISCUSSION: A main strength of the present study is that it addresses a population of importance and a factor (EL) whose understanding can influence future interventions. A second strength is its relatively large sample size of a high-risk population. Third, unlike studies that have shown an association between self-reported fitness and educational level we assessed physical fitness measures by a quantitative and validated test battery using assessors blinded to other data. Another novelty is the extensive evaluation of the role of many relevant confounder variables. CONCLUSIONS: In conclusion, we show that in patients with type 2 diabetes EL correlates favorably and independently with important health-related physical fitness measures such as aerobic fitness, walking speed, and lower limb strength. Our findings underline that diabetic patients with low EL should be specifically encouraged to participate in physical activity intervention programs to further reduce social disparities in healthcare. Such programs should be structured and integrate the norms, needs and capacities (financial, time, physical capacities and self-efficacy) of this population, and their effectiveness should be tested in future studies. TRIAL REGISTRATION: University of Lausanne clinicaltrials.gov NCT01289587.