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

Balducci, Stefano; Zanuso, Silvano; Massarini, Massimo; Corigliano, Gerardo; Nicolucci, Antonio; Missori, Serena; Cavallo, Stefano; Cardelli, Patrizia; Alessi, Elena; Pugliese, Giuseppe; Fallucca, F.

doi:10.1016/j.numecd.2007.07.006

Cited by 51 publications

(61 citation statements)

References 48 publications

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“…Design and methods of this multicentre parallel randomised, open-label, controlled trial have been detailed elsewhere [15,16] and will be briefly reported here. The research protocol was approved by locally appointed ethics committees and participants gave written informed consent.…”

Section: Methodsmentioning

confidence: 99%

“…The training programme for the EXE group consisted of 150 min/week in two supervised sessions of progressive mixed (aerobic and resistance) training [15,16]. Aerobic training was performed using treadmill, step, elliptical, arm or cycleergometer.…”

Section: Setting and Participantsmentioning

confidence: 99%

“…Standard care consisted of a treatment regimen aimed at achieving optimal glycaemic, lipid, BP and body weight targets, as established by current guidelines, and including diet prescription and glucose-, lipid-and BP-lowering agents as needed. The treatment regimen was adjusted based on results of biochemical tests performed locally at 3-month intervals [15,16].…”

Section: Setting and Participantsmentioning

confidence: 99%

“…Methods for the assessment of these endpoints, as well as of the volume of PA and variables of physical fitness, have been reported elsewhere [15,16].…”

Section: Setting and Participantsmentioning

confidence: 99%

“…A priori secondary outcomes also included physical and mental health-related QoL [14,16]. To this end, patients were asked to fill in the Italian version [20] of the 36-Item Short Form Health Survey (SF-36) [21], which yields physical and mental health component scores and has been previously validated in patients with type 2 diabetes [22,23].…”

Section: Setting and Participantsmentioning

confidence: 99%

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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)

et al. 2012

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Aims/hypothesis 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 treatment 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

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Section: Methodsmentioning

confidence: 99%

Section: Setting and Participantsmentioning

confidence: 99%

Section: Setting and Participantsmentioning

confidence: 99%

“…Methods for the assessment of these endpoints, as well as of the volume of PA and variables of physical fitness, have been reported elsewhere [15,16].…”

Section: Setting and Participantsmentioning

confidence: 99%

Section: Setting and Participantsmentioning

confidence: 99%

See 3 more Smart Citations

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)

et al. 2012

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Effect of an Intensive Exercise Intervention Strategy on Modifiable Cardiovascular Risk Factors in Subjects With Type 2 Diabetes Mellitus<subtitle>A Randomized Controlled Trial: The Italian Diabetes and Exercise Study (IDES)</subtitle><alt-title>Intensive Exercise and Modifiable CV Risk Factors</alt-title>

Balducci¹

2010

Arch Intern Med

286

250

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This exercise intervention strategy was effective in promoting PA and improving HbA(1c) 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: ISRCTN04252749.

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Improvement of Quality of Life With Supervised Exercise Training in Subjects With Type 2 Diabetes Mellitus

Nicolucci

Balducci²,

Cardelli³

et al. 2011

Arch Intern Med

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lower for the intervention than for the control group. Although this difference was not statistically significant, it corresponds with an estimated 0.4 life-years gained. From the British Doctors study 1 it is possible to estimate that an intervention that yielded an increased cessation rate at the 12-month follow-up of 30% (39% vs 9%) in smokers with the age distribution represented in this study would be expected to yield approximately 0.8 lifeyears. 9 The Table also shows lower hazard ratios for many specific causes of death in the intervention group compared with the control group, though none were statistically significant at conventional levels. As might be expected, the largest putative effect size was for lung cancer. Comment. Although this study had low power to detect a long-term effect on mortality of the size predicted from the British Doctors study, 1 to our knowledge, these data provide the best estimate of such an intervention to date. This estimated gain of 0.4 lifeyears was approximately half what might be expected from the British Doctors cohort study. 1 In addition to the low sample size, several factors may have militated against showing an effect of the kind predicted. First, there was no biochemical verification of abstinence, so at least some of the "effect" may have resulted from misreporting by smokers in the intervention group who did not want to admit that they were not able to stop. 10 Second, brief advice without pharmacological support tends to lead to cessation in lighter, less nicotinedependent smokers, with heavier smokers requiring more support. 11 These light smokers would have been exposed to less-than-average risk from their smoking.

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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

Cited by 51 publications

References 48 publications

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)

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)

Improvement of Quality of Life With Supervised Exercise Training in Subjects With Type 2 Diabetes Mellitus

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