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Physical activity/exercise training in type 2 diabetes. The role of the Italian Diabetes and Exercise Study
Cardiorespiratory fitness is inversely related to the development of type 2 diabetes and cardiovascular morbidity and mortality. Trials in individuals with impaired glucose tolerance have highlighted the role of physical activity/exercise in the prevention of type 2 diabetes. Moreover, physical activity and exercise training have been recognized as treatment options for patients with type 2 diabetes. Both aerobic and resistance training were shown to produce beneficial effects by reducing HbA1c, inducing weight loss and improving fat distribution, lipid profile and blood pressure in patients with type 2 diabetes. Mixed aerobic and resistance training was recently shown to be more effective than either one alone in ameliorating HbA1c. However, further research is needed to establish the volume, intensity and type of exercise that are required to reduce cardiovascular burden and particularly to define the best strategy for promoting long-term compliance and durable lifestyle changes in individuals with type 2 diabetes. The Italian Diabetes Exercise Study (IDES) is a prospective Italian multicentre randomized controlled trial, of larger size and longer duration than previously published trials. It has been designed to assess the combined effect of structured counselling and supervisedmixed (aerobic plus resistance) exercise training, as compared with counselling alone, on HbA1c and other cardiovascular risk factors as well as fitness parameters in individuals with type 2 diabetes and the metabolic syndrome. This study was also aimed at testing a sustainable strategy for promoting and maintaining a sufficient level of physical activity among individuals with type 2 diabetes to be implemented at the population level. Copyright © 2009 John Wiley & Sons, Ltd
The Italian Diabetes and Exercise Study (IDES): Design and methods for a prospective Italian multicentre trial of intensive lifestyle intervention in people with type 2 diabetes and the metabolic syndrome
Background and aims: The IDES is a prospective Italian multicentre randomized controlled trial to evaluate the efficacy of an intensive lifestyle intervention on modifiable cardiovascular disease (CVD) risk factors in a large cohort of people with type 2 diabetes and the metabolic syndrome. Methods and results: We recruited 606 subjects with type 2 diabetes and waist circumference >94 cm (M) and >80 cm (F), plus >1 other metabolic syndrome trait (IDF criteria) for both sexes, aged 40e75 years, BMI 27e40 kg/m2, diabetes duration >1 year with a sedentary lifestyle of >6 months. Patients were randomized into two groups: a control group, receiving conventional care including exercise counselling and an intervention group, treated with a mixed (aerobic and resistance) exercise programme (150 min/week) prescribed and supervised for 12 months. Primary outcome is HbA1c reduction. Secondary outcomes include other traditional and non-traditional risk factors and their relationship to exercise volume/intensity and fitness; dosage of glucose, lipid and blood pressure-lowering drugs; global CVD 10-year risk; patient well-being; and costs. Conclusion: This trial verifies whether a prescribed and supervised exercise programme, including both aerobic and resistance training, is more effective than conventional exercise counselling in reducing modifiable CVD risk factors in type 2 diabetic subjects with the metabolic syndrome
The Italian Diabetes and Exercise Study (IDES) : design and methods for a prospective Italian multicentre trial of intensive lifestyle intervention in people with type 2 diabetes and the metabolic syndrome
The IDES is a prospective Italian multicentre randomized controlled trial to evaluate the efficacy of an intensive lifestyle intervention on modifiable cardiovascular disease (CVD) risk factors in a large cohort of people with type 2 diabetes and the metabolic syndrome. METHODS AND RESULTS: We recruited 606 subjects with type 2 diabetes and waist circumference >94 cm (M) and >80 cm (F), plus >1 other metabolic syndrome trait (IDF criteria) for both sexes, aged 40-75 years, BMI 27-40 kg/m(2), diabetes duration >1 year with a sedentary lifestyle of >6 months. Patients were randomized into two groups: a control group, receiving conventional care including exercise counselling and an intervention group, treated with a mixed (aerobic and resistance) exercise programme (150 min/week) prescribed and supervised for 12 months. Primary outcome is HbA1c reduction. Secondary outcomes include other traditional and non-traditional risk factors and their relationship to exercise volume/intensity and fitness; dosage of glucose, lipid and blood pressure-lowering drugs; global CVD 10-year risk; patient well-being; and costs. CONCLUSION: This trial verifies whether a prescribed and supervised exercise programme, including both aerobic and resistance training, is more effective than conventional exercise counselling in reducing modifiable CVD risk factors in type 2 diabetic subjects with the metabolic syndrom
Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: A randomized controlled trial: The Italian Diabetes and Exercise Study (IDES)
Background: This study aimed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity (PA) and improving hemoglobin A1c (HbA1c) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM). Methods: Of 691 eligible sedentary patients with T2DM and the metabolic syndrome, 606 were enrolled in 22 outpatient diabetes clinics across Italy and randomized by center, age, and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling (exercise group) vs counseling alone (control group) for 12 months. End points included HbA1c level (primary) and other cardiovascular risk factors and coronary heart disease risk scores (secondary). Results: The mean (SD) volume of PA (metabolic equivalent hours per week) was significantly higher (P < .001) in the exercise (total PA [nonsupervised conditioning PA + supervised PA], 20.0 [0.9], and nonsupervised, 12.4 [7.4]) vs control (10.0 [8.7]) group. Compared with the control group, supervised exercise produced significant improvements (mean difference [95% confidence interval]) in physical fitness; HbA 1c level (-0.30% [-0.49% to -0.10%]; P < .001); systolic (-4.2 mm Hg [-6.9 to -1.6 mmHg]; P=.002) and diastolic (-1.7mmHg [-3.3 to -1.1 mm Hg]; P=.03) blood pressure; high-density lipoprotein (3.7 mg/dL [2.2 to 5.3 mg/dL]; P < .001) and low-density lipoprotein (-9.6 mg/dL [-15.9 to -3.3 mg/dL]; P=.003) cholesterol level; waist circumference (-3.6 cm [-4.4 to -2.9 cm]; P < .001); body mass index; insulin resistance; inflammation; and risk scores. These parameters improved only marginally in controls. Conclusions: This exercise intervention strategy was effective in promoting PA and improving HbA1c and cardiovascular risk profile. Conversely, counseling alone, though successful in achieving the currently recommended amount of activity, was of limited efficacy on cardiovascular risk factors, suggesting the need for a larger volume of PA in these high-risk subjects. Trial Registration: isrctn.org Identifier: ISRCTN-04252749 ©2010 American Medical Association. All rights reserved
Relationship of exercise volume to improvements of quality of life with supervised exercise training in patients with type 2 diabetes in a randomised controlled trial: the Italian Diabetes and Exercise Study (IDES)
A positive impact of exercise intervention programmes on quality of life (QoL) may be important for long-term patient compliance to exercise recommendations. We have previously shown that QoL improves significantly with supervised exercise, whereas it worsens with counselling alone, in patients with type 2 diabetes from the Italian Diabetes and Exercise Study (IDES). Here, we report data on the relationship between changes in QoL and volume of physical activity/exercise in these individuals. Methods This multicentre parallel randomised controlled, open-label, trial enrolled sedentary patients with type 2 diabetes (n0606 of 691 eligible) in 22 outpatient diabetes clinics.
Patients were randomised by centre, age and diabetes reatment using a permuted-block design to twice-a-week supervised aerobic and resistance training plus exercise counselling (exercise group) versus counselling alone (control group) for 12 months. Health-related QoL was ssessed by the 36-Item Short Form (SF-36) Health Survey. Results In the exercise group (n0268 of 303 randomised), there was a trend for increasing QoL with increasing exercise volume, with significant improvement of the hysical component summary (PCS) measure only above 17.5 metabolic equivalents h−1 week −1 and a clear volume-relationship for the mental component summary (MCS) measure. A relationship with volume of physical activity also was observed in the control group (n0260 of 303 randomised), despite overall deterioration of all scores. Independent correlates of improvements in both PCS and MCS were exercise volume, study arm and, inversely, baseline score. Conclusions/interpretation This large trial shows a relationship between changes in physical and mental health-related QoL measures and volume of physical activity/exercise, with supervised exercise training also providing volume independent benefits
Effect of an intensive exercise intervention strategy on modifiable cardiovascular risk factors in subjects with type 2 diabetes mellitus: a randomized controlled trial: the Italian Diabetes and Exercise Study (IDES)
Background: This study aimed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity (PA) and improving hemoglobin A1c (HbA1c) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM). Methods: Of 691 eligible sedentary patients with T2DM and the metabolic syndrome, 606 were enrolled in 22 outpatient diabetes clinics across Italy and randomized by center, age, and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling (exercise group) vs counseling alone (control group) for 12 months. End points included HbA1c level (primary) and other cardiovascular risk factors and coronary heart disease risk scores (secondary). Results: The mean (SD) volume of PA (metabolic equivalent hours per week) was significantly higher (P < .001) in the exercise (total PA [nonsupervised conditioning PA + supervised PA], 20.0 [0.9], and nonsupervised, 12.4 [7.4]) vs control (10.0 [8.7]) group. Compared with the control group, supervised exercise produced significant improvements (mean difference [95% confidence interval]) in physical fitness; HbA 1c level (-0.30% [-0.49% to -0.10%]; P < .001); systolic (-4.2 mm Hg [-6.9 to -1.6 mmHg]; P=.002) and diastolic (-1.7mmHg [-3.3 to -1.1 mm Hg]; P=.03) blood pressure; high-density lipoprotein (3.7 mg/dL [2.2 to 5.3 mg/dL]; P < .001) and low-density lipoprotein (-9.6 mg/dL [-15.9 to -3.3 mg/dL]; P=.003) cholesterol level; waist circumference (-3.6 cm [-4.4 to -2.9 cm]; P < .001); body mass index; insulin resistance; inflammation; and risk scores. These parameters improved only marginally in controls. Conclusions: This exercise intervention strategy was effective in promoting PA and improving HbA1c and cardiovascular risk profile. Conversely, counseling alone, though successful in achieving the currently recommended amount of activity, was of limited efficacy on cardiovascular risk factors, suggesting the need for a larger volume of PA in these high-risk subjects. Trial Registration: isrctn.org Identifier: ISRCTN-0425274
Level and correlates of physical activity and sedentary behavior in patients with type 2 diabetes. a cross-sectional analysis of the italian diabetes and exercise study-2
Objective Patients with type 2 diabetes usually show reduced physical activity (PA) and increased sedentary (SED)-time, though to a varying extent, especially for low-intensity PA (LPA), a major determinant of daily energy expenditure that is not accurately captured by questionnaires. This study assessed the level and correlates of PA and SED-time in patients from the Italian Diabetes and Exercise Study-2 (IDES-2). Methods Three-hundred physically inactive and sedentary patients with type 2 diabetes were enrolled in the IDES-2 to be randomized to an intervention group, receiving theoretical and practical exercise counseling, and a control group, receiving standard care. At baseline, LPA, moderate- to-vigorous-intensity PA (MVPA), and SED-time were measured by accelerometer. Physical fitness and cardiovascular risk factors and scores were also assessed. Results LPA was 3.93±1.35 hours·day-1, MVPA was 12.4±4.6 min·day-1, and SED-time was 11.6 ±1.2 hours·day-1, with a large range of values (0.89±7.11 hours·day-1, 0.6±21.0 min·day-1, and 9.14±15.28 hours·day-1, respectively). At bivariate analysis, LPA and MVPA correlated with better cardiovascular risk profile and fitness parameters, whereas the opposite was observed for SED-time. Likewise, values of LPA, MVPA, and SED-time falling in the best tertile were associated with optimal or acceptable levels of cardiovascular risk factors and scores. At multivariate analysis, age, female gender, HbA1c, BMI or waist circumference, and high-sensitivity C reactive protein (for LPA and SED-time only) were negatively associated with LPA and MPA and positively associated with SED-time in an independent manner. Conclusions Physically inactive and sedentary patients with type 2 diabetes from the IDES-2 show a low level of PA, though values of LPA, MVPA, and SED-time vary largely. Furthermore, there is a strong correlation of these measures with glycemic control, adiposity and inflammation, thus suggesting that even small improvements in LPA, MVPA, and SED-time might be associated with significant improvement in cardiovascular risk profile
Effect of a behavioral intervention strategy for adoption and maintenance of a physically active lifestyle. The Italian diabetes and exercise study 2 (IDES-2). A randomized controlled trial
OBJECTIVE Adherence to physical activity (PA) recommendations is hampered by the lack of effective strategies to promote behavior change. The Italian Diabetes and Exercise Study 2 (IDES-2) is a randomized controlled trial evaluating a novel behavioral intervention strategy for increasing PA and decreasing sedentary time (SED-time) in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS The study randomized 300 physically inactive and sedentary patients with type 2 diabetes 1:1 to receive theoretical and practical counseling once yearly for 3 years (intervention group [INT]) or standard care (control group [CON]). Here, we report the 4-month effects on objectively (accelerometer)measured daily light-intensity PA (LPA), moderate-to-vigorous-intensity PA (MVPA), and SED-time, and cardiovascular risk factors. RESULTS LPA and MVPA both increased, and SED-time decreased in both groups, although changes were significantly more marked in INT participants (approximately twofold for LPA and SED-time and approximately sixfold forMVPA). A significant reduction in HbA1c was observed only in INT subjects. An increase in LPA >0.92 h · day-1 and in MVPA >7.33 min · day-1 and a decrease in SED-time >1.05 h · day-1 were associated with an average decrease in HbA1c of 1% and alsowith significant improvements in fasting glucose, body weight, waist circumference, and hs-CRP. Changes in PA and SED-time were independent predictors of improvements in HbA1c. CONCLUSIONS This behavioral intervention is effective in the short term for increasing LPA and MVPA and reducing SED-time. Significant improvements in cardiometabolic risk profiles were observed in subjects experiencing the most pronounced changes in PA and SED-time, even if below the recommended level
Effect of supervised exercise training on musculoskeletal symptoms and function in patients with type 2 diabetes: the Italian Diabetes Exercise Study (IDES)
Musculoskeletal disorders are common in subjects with type 2 diabetes mellitus (T2DM) and may represent a barrier to physical activity (PA). In the Italian Diabetes and Exercise Study, we assessed whether a strategy aimed at minimizing the risk of injury and worsening of musculoskeletal symptoms favors participation in exercise training and results in improvements in joint-specific functional scores, along with amelioration of metabolic profile. Sedentary patients with T2DM (n = 606) from 22 outpatient diabetes clinics were randomized to twice-a-week supervised aerobic and resistance training plus exercise counseling (EXE) versus counseling alone (CON) for 12 months. Musculoskeletal symptoms were evaluated at baseline in the entire cohort by the use of a self-reported questionnaire in order to design tailored exercise programs with exclusion of painful segments, and validated joint-specific scores were calculated at the end of study in a subgroup of CON (n = 65) and EXE subjects (n = 62). Musculoskeletal symptoms were present in more than 3/4 of EXE and CON subjects. Yet, volumes of non-supervised PA were high, whereas dropout rates and adverse events were low in both groups. Moreover, in the EXE group, no difference was observed between patients with and without symptoms in session attendance and PA/exercise volume. Scores for symptoms and functional status of limbs and spine were significantly better in EXE than in CON subjects and correlated with PA/exercise volume and improvements in fitness parameters. Preliminary evaluation of musculoskeletal symptoms is useful in favoring compliance with supervised training programs and obtaining significant benefits to the functional status of the involved joints. © 2014 Springer-Verlag.Musculoskeletal disorders are common in subjects with type 2 diabetes mellitus (T2DM) and may represent a barrier to physical activity (PA). In the Italian Diabetes and Exercise Study, we assessed whether a strategy aimed at minimizing the risk of injury and worsening of musculoskeletal symptoms favors participation in exercise training and results in improvements in joint-specific functional scores, along with amelioration of metabolic profile. Sedentary patients with T2DM (n = 606) from 22 outpatient diabetes clinics were randomized to twice-a-week supervised aerobic and resistance training plus exercise counseling (EXE) versus counseling alone (CON) for 12 months. Musculoskeletal symptoms were evaluated at baseline in the entire cohort by the use of a self-reported questionnaire in order to design tailored exercise programs with exclusion of painful segments, and validated joint-specific scores were calculated at the end of study in a subgroup of CON (n = 65) and EXE subjects (n =
Supervised exercise training counterbalances the adverse effects of insulin therapy in overweight/obese subjects with type 2 diabetes
OBJECTIVE To examine the effect of supervised exercise on traditional and nontraditional cardiovascular risk factors in sedentary, overweight/obese insulin-treated subjects with type 2 diabetes from the Italian Diabetes Exercise Study (IDES).
RESEARCH DESIGN AND METHODS The study randomized 73 insulin-treated patients to twice weekly supervised aerobic and resistance training plus structured exercise counseling (EXE) or to counseling alone (CON) for 12 months. Clinical and laboratory parameters were assessed at baseline and at the end of the study.
RESULTS The volume of physical activity was significantly higher in the EXE versus the CON group. Values for hemoglobin A1c, BMI, waist circumference, high-sensitivity C-reactive protein, blood pressure, LDL cholesterol, and the coronary heart disease risk score were significantly reduced only in the EXE group. No major adverse events were observed.
CONCLUSIONS In insulin-treated subjects with type 2 diabetes, supervised exercise is safe and effective in improving glycemic control and markers of adiposity and inflammation, thus counterbalancing the adverse effects of insulin on these parameters
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