The Effects Of A Supervised 12-week Walking Program On Inflammatory Markers, Fatigue, And Free-living Physical Activity In Aging Women With Type 2 Diabetes

Principal Investigators

Dates: 8/1/2016 - 2/28/2018

Co-Investigators:  Cynthia Fritschi, Lauretta Quinn, Ulf Bronas, Chang Park

Abstract:  Type 2 diabetes (T2DM) is strongly associated with early frailty. Life spent disabled is twofold higher with the worst prognosis seen in women who are obese and are physically inactive. Participation in regular physical activity (PA) is paramount for maintaining independence and decrease long-term complications. However, obese midlife women with T2DM remain the least likely to participate in regular PA in citing fatigue as a major barrier. Our long-term goal is to understand the biological pathway of fatigue in post-menopausal women with T2DM and to develop interventions to decrease fatigue burden, and help them to maintain physical function. Emerging evidence suggests that fatigue is associated with chronic low-grade inflammation brought on by the metabolic milieu present in T2DM. Exercise in known to affect both fatigue and inflammation. However, it is currently unknown whether exercise can reduce fatigue burden in post-menopausal women with T2DM and no study has investigated whether changes in fatigue is mediated by an exercise-induced reduction in inflammation.
Aims: The purpose of this study is to test the hypothesis that moderate intensity exercise training will reduce chronic systemic inflammation and that the improvement in inflammation will be related to a decrease in fatigue in post-menopausal women with T2DM over 12-weeks compared to standard care. We further postulate that the reduction in fatigue will be associated with increased levels of free-living physical activity.
Sample: Fifteen post-menopausal women (>55) with T2DM and fatigue will be randomized to a 12-week, supervised exercise walking program (n=10) or standard care (n=5).

Approach: The intervention group will participate in a 12-week exercise program consisting of supervised treadmill walking, moderate-intensity exercise 3 times/week for 30-45 minutes. The control group will receive standard care. The primary aim is change in inflammation (hs-CRP, IL-6, TNF, neopterin) and fatigue from baseline to 12-weeks, and to discern whether changes in inflammation and fatigue are associated. Secondary outcomes are change in free-living physical activity and to assess whether changes in fatigue levels and change in free-living physical activity are associated. Results of these tests will provide insight into the biological pathway of fatigue and its influence on free-living physical activity. We anticipate to gain insight into the feasibility and effect size for submission of a large scale NIH proposal. Our primary outcomes is measured following 12 weeks of the walking program, however, we will also test patients at 6 weeks to ascertain if we can move forward more quickly. Mixed effects models (with mediation analyses) will be used in the analyses.

Internal Research Support Program