Aims <p>To assess the effect of a 1-year supervised exercise training program on long-term mortality in people with type 2 diabetes.</p> Methods <p>This is a post hoc analysis of the Italian Diabetes and Exercise Study randomized clinical trial, which enrolled 606 physically inactive and sedentary individuals with type 2 diabetes from October 2005 to March 2006. Participants were randomized 1:1 to either an exercise group (EXE) receiving a twice-weekly, progressive, supervised aerobic and resistance exercise training plus a physical activity (PA) counseling or a control group (CON) receiving counseling alone for one year. The vital status of participants was verified on 30 June 2024 by interrogating the Italian Health Card database.</p> Results <p>A similar number of EXE and CON participants died over a mean 16.2-year follow-up (88 vs. 95, <i>p</i> = 0.536). Likewise, no between-group differences were detected in death rates (unadjusted, 17.62 [95% confidence interval, 14.30-21.71] vs. 19.59 [16.02–23.96] per 1,000 patient-years, <i>p</i> = 0.483; and age- and sex-adjusted, 16.46 [12.81–21.13] vs. 17.93 [13.92–23.09], <i>p</i> = 0.563). Kaplan-Meier estimates (Log Rank = 0.647, <i>p</i> = 0.421) and mortality risk (unadjusted, hazard ratio, 0.888 [95% confidence interval, 0.664–1.187], <i>p</i> = 0.442; and age- and sex-adjusted, 0.922 [0.689–1.233], <i>p</i> = 0.584). A significant relation with mortality was observed for baseline maximal oxygen uptake (VO<sub>2max</sub>), but not lower body muscle strength, regardless of study arm, whereas no association was detected for changes from baseline in leisure-time PA, total PA volume, VO<sub>2max</sub>, and lower body muscle strength.</p> Conclusions <p>In people with type 2 diabetes, a one-year supervised exercise training program had no significant effect on long-term mortality.</p> Trial registration <p>isrctn.com; ISRCTN-04252749; URL <a href="https://www.isrctn.com/ISRCTN04252749">https://www.isrctn.com/ISRCTN04252749</a>.</p>

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Effect of a 1-year supervised exercise intervention on long-term mortality in people with type 2 diabetes

  • Stefano Balducci,
  • Jonida Haxhi,
  • Martina Vitale,
  • Lorenza Mattia,
  • Francesco Calvi,
  • Martina Marini,
  • Eleonora Ciocca,
  • Federica Auccello,
  • Andrea Gentile,
  • Lucilla Bollanti,
  • Massimo Sacchetti,
  • Giorgio Orlando,
  • Antonio Nicolucci,
  • Giuseppe Pugliese

摘要

Aims

To assess the effect of a 1-year supervised exercise training program on long-term mortality in people with type 2 diabetes.

Methods

This is a post hoc analysis of the Italian Diabetes and Exercise Study randomized clinical trial, which enrolled 606 physically inactive and sedentary individuals with type 2 diabetes from October 2005 to March 2006. Participants were randomized 1:1 to either an exercise group (EXE) receiving a twice-weekly, progressive, supervised aerobic and resistance exercise training plus a physical activity (PA) counseling or a control group (CON) receiving counseling alone for one year. The vital status of participants was verified on 30 June 2024 by interrogating the Italian Health Card database.

Results

A similar number of EXE and CON participants died over a mean 16.2-year follow-up (88 vs. 95, p = 0.536). Likewise, no between-group differences were detected in death rates (unadjusted, 17.62 [95% confidence interval, 14.30-21.71] vs. 19.59 [16.02–23.96] per 1,000 patient-years, p = 0.483; and age- and sex-adjusted, 16.46 [12.81–21.13] vs. 17.93 [13.92–23.09], p = 0.563). Kaplan-Meier estimates (Log Rank = 0.647, p = 0.421) and mortality risk (unadjusted, hazard ratio, 0.888 [95% confidence interval, 0.664–1.187], p = 0.442; and age- and sex-adjusted, 0.922 [0.689–1.233], p = 0.584). A significant relation with mortality was observed for baseline maximal oxygen uptake (VO2max), but not lower body muscle strength, regardless of study arm, whereas no association was detected for changes from baseline in leisure-time PA, total PA volume, VO2max, and lower body muscle strength.

Conclusions

In people with type 2 diabetes, a one-year supervised exercise training program had no significant effect on long-term mortality.

Trial registration

isrctn.com; ISRCTN-04252749; URL https://www.isrctn.com/ISRCTN04252749.