Use the Back button in your browser to see the other results of your search or to select another record.

Detailed Search Results

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)
Balducci S, Zanuso S, Nicolucci A, de Feo P, Cavallo S, Cardelli P, Fallucca S, Alessi E, Fallucca F, Pugliese G, Italian Diabetes Exercise Study (IDES) Investigators
Archives of Internal Medicine 2010 Nov 8;170(20):1794-1803
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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) versus 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 < 0.001) in the exercise (total PA (nonsupervised conditioning PA and supervised PA), 20.0 (0.9), and nonsupervised, 12.4 (7.4)) versus control (10.0 (8.7)) group. Compared with the control group, supervised exercise produced significant improvements (mean difference (95% confidence interval)) in physical fitness; HbA1c level (-0.30% (-0.49% to -0.10%); p < 0.001); systolic (-4.2 mmHg (-6.9 to -1.6 mmHg); p = 0.002) and diastolic (-1.7 mmHg (-3.3 to -1.1 mmHg); p = 0.03) blood pressure; high-density lipoprotein (3.7 mg/dL (2.2 to 5.3 mg/dL); p < 0.001) and low-density lipoprotein (-9.6 mg/dL (-15.9 to -3.3 mg/dL); p = 0.003) cholesterol level; waist circumference (-3.6 cm (-4.4 to -2.9 cm); p < 0.001); 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.

Full text (sometimes free) may be available at these link(s):      help