For people with type 2 diabetes, lifestyle change – diet and exercise – is critical to managing the disease. The American Diabetes Association (ADA) drove home this point with a position statement on the importance of physical activity for this patient population.

The ADA states:

• "All adults, and particularly those with type 2 diabetes, should decrease the amount of time spent in daily sedentary behavior.
• "Prolonged sitting should be interrupted with bouts of light activity every 30 min for blood glucose benefits, at least in adults with type 2 diabetes.
• "The above two recommendations are additional to, and not a replacement for, increased structured exercise and incidental movement."

"All evidence suggests that most adults fail to meet recommended daily amounts of physical activity, and those with type 2 diabetes are even less likely to meet the guidelines," Sheri R. Colberg, Professor Emerita (Exercise Science) at Old Dominion University, Prescott, Arizona told BreakingMED in an email correspondence. "This is occurring for many reasons, but perceived lack of time, injury, and lack of enjoyment are common factors leading to exercise program nonparticipation. Simply telling patients to 'be more active' is not that effective."

And this is precisely what the Italian Diabetes and Exercise Study 2 (IDES2) decided to look at – the difference between the standard of care, such as recommendations to follow ADA guidelines, versus a behavioral intervention designed to motivate and help patients increase their activity.

Publishing the results of their randomized trial in JAMA Giuseppe Pugliese, MD, PhD, department of Clinical and Molecular Medicine, La Sapienza University, Rome and colleagues found that a behavioral intervention strategy helped type 2 diabetes patients reduce their sedentary behaviors and increase physical activity better than standard care, over a 3-year period.

"Likely, the most important finding of this clinical trial is that a behavioral intervention can increase the total volume of physical activity done by adults with type 2 diabetes," noted Colberg, who was not associated with the study but is one of the co-authors of the ADA guidelines. "Of note is the fact that most of the sustained increase over three years came in the form of light physical activity (such as simply moving more during the day), not necessarily from planned moderate or vigorous exercise."

300 participants of IDES2 were randomized to the study (mean SD age 61.6 [8.5] years, 116 [38.7%] were women). Of these, 267 completed the study and were randomized to either the behavioral intervention group (n=133) or to the standard care group (n=134).

The behavioral intervention group accumulated 13.8 metabolic equivalent hours per week of physical activity volume versus 10.5 in the standard of care group (difference, 3.3 [95%CI, 2.2-4.4]; P=<.001).

Looking at exercise intensity, the intervention group still came out ahead of the standard of care group:

• Moderate- to vigorous-intensity physical activity 18.9 versus 12.5 minutes per day, respectively (difference, 6.4 [95%CI,5.0-7.8]; P< .001).
• Light-intensity physical activity 4.6 versus 3.8 hours per day, respectively (difference, 0.8 [95%CI, 0.5-1.1]; P< .001).

And over the study period sedentary time increased more for the standard of care group -- 10.9 versus 11.7 hours per day, respectively (difference, –0.8 [95%CI, –1.0 to –0.5]; P < .001).

By the third year there was a drop in moderate- to vigorous-intensity activity, but still the behavioral intervention group outpaced the standard of care group at 6.5 to 3.6 minutes per day, respectively.

"This behavioral intervention strategy was successful in increasing physical activity volume by reallocating sedentary time to light-intensity physical activity and, to a lesser extent, moderate-to vigorous-intensity physical activity," Pugliese and colleagues wrote. "Significant between-group differences were maintained throughout the study period for all the co-primary endpoints; however, the difference in moderate-to vigorous-intensity physical activity diminished during the third year, suggesting that moderate-to-vigorous-intensity physical activity is more difficult to maintain with time and increasing age."

The primary endpoints of the study were to see changes in physical activity volume over baseline. The secondary endpoints were improvements in physical fitness.

The behavioral intervention consisted of one theoretical counseling session with a diabetologist per year, and 8 biweekly individual theoretical and practical counseling sessions with a certified exercise specialist, per year, over the three-year study period per the IDES protocol.

Activity was measured by a wearable accelerometer (MyWellness Key).

The study authors reported adverse events among the two groups – 41 in the behavioral intervention group and 59 in the standard of care group. In the behavioral group there were "8 episodes of mild hypoglycemia, 3 episodes of tachycardia/arrhythmia, and 19 episodes of musculoskeletal injury/discomfort during the theoretical and practical counseling sessions," they explained.

The study's limitations include whether it is generalizable and able to be implemented in various clinical settings; accelerometer use may have promoted more activity in the standard care group, and it was also not possible to determine actual sedentary time.

Colberg agreed that a limitation was a lack of generalizability. "This trial still experienced over a 10% dropout rate over three years. Moreover, even the behavioral intervention group experienced a decline in engagement in moderate to vigorous physical activity by the third year of the study," she noted.

"Much remains to be done to increase the number of adults for whom behavioral change outreach education is available," Colberg observed. "A recent trend has been the proliferation of online physical activity tracking tools and accelerometry use. In addition, the American College of Sports Medicine has been pushing for over a decade to have exercise included as a recorded 'vital sign' during patient visits to clinicians."

Still, Colberg noted that increasing light physical activity can be as simple as "standing more, taking more daily steps, engaging in more activities of daily living, and breaking up sedentary time with activity breaks" and is more likely to be sustained over time. "Clinicians may simply be able to prescribe frequent breaks in sedentary time and get these results," she said.


Disclosure:

Pugliese disclosed relevant relationships with AstaZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dohme, Mylan, and Sigma-Tau. Several co-authors disclosed similar relationships with AstraZeneca, Eli Lilly, Novo Nordisk, Takeda, Sanofi Aventis and others.