Abstract
Background Exercise is recommended for people with diabetes, but little is known about exercise in people with diabetic peripheral neuropathy (DPN).
Objective The primary purpose of this preliminary study was to examine adverse events (AEs) during moderate-intensity, supervised aerobic exercise in people with DPN. The secondary purpose was to examine changes in fatigue, aerobic fitness, and other outcomes after intervention.
Design This was a single-group preliminary study.
Setting The setting was an academic medical center.
Participants Participants were 18 people who were sedentary and had type 2 diabetes and peripheral neuropathy (mean age=58.1 years, SD=5).
Intervention The intervention was a supervised 16-week aerobic exercise program (3 times per week at 50% to >70% oxygen uptake reserve).
Measurements Adverse events were categorized as related or unrelated to the study, anticipated or unanticipated, and serious or not serious. Outcomes included fatigue (Multidimensional Fatigue Inventory), cardiovascular fitness (peak oxygen uptake), body composition (dual-energy x-ray absorptiometry), sleep quality, plasma metabolic markers, and peripheral vascular function.
Results During the study, 57 nonserious AEs occurred. Improvements were found in general fatigue (mean change=−3.5; 95% confidence interval [95% CI]=−1.3, −5.3), physical fatigue (mean change=−3.1; 95% CI=−1.2, −5.0), peak oxygen uptake (mean change=1.1 mL·kg−1·min−1; 95% CI=0.2, 1.9), total body fat (mean change=−1%; 95% CI=−0.3, −1.7), fat mass (mean change=−1,780 g; 95% CI=−616.2, −2,938.7), and peripheral blood flow (mean change=2.27%; 95% CI=0.6, 4.0).
Limitations This was a small-scale, uncontrolled study. A future randomized controlled trial is needed to fully assess the effects of exercise on the outcomes.
Conclusions This study provides new support for supervised aerobic exercise in people with DPN. However, it is important for physical therapists to carefully prescribe initial exercise intensity and provide close monitoring and education to address the anticipated AEs as people who are sedentary and have DPN begin an exercise program.
Footnotes
Dr Kluding, Dr Singh, Ms D'Silva, Mr Yoo, Dr Dimachkie, and Dr Wright provided concept/idea/research design. Dr Kluding, Mr Yoo, Dr Billinger, Dr LeMaster, Dr Dimachkie, Ms Herbelin, and Dr Wright provided writing. Dr Kluding, Dr Pasnoor, Dr Singh, Ms D'Silva, Mr Yoo, and Dr Billinger provided data collection. Dr Kluding, Ms D'Silva, Mr Yoo, Dr Billinger, Dr LeMaster, Dr Dimachkie, and Dr Wright provided data analysis. Dr Kluding, Ms D'Silva, Mr Yoo, and Dr Wright provided project management. Dr Kluding provided fund procurement, participants, and institutional liaisons. Dr Kluding, Dr Billinger, Ms Herbelin, and Dr Wright provided facilities/equipment. Mr Yoo provided administrative support. Dr Pasnoor, Dr Singh, Ms D'Silva, Dr Billinger, Dr LeMaster, Dr Dimachkie, and Dr Wright provided consultation (including review of the manuscript before submission). The authors acknowledge the essential contributions of Bill Hendry, CES, and the medical monitors and nursing staff at the Clinical and Translational Science Unit for exercise testing; Jason-Flor Sisante for vascular scans; Christian Pearson for nerve testing; and Katherine Martin, Gurpreet Singh, Ali Bani-Ahmed, Chelsea Kufahl, Kayla Lingenfelter, and Sara Nelson for supervising the exercise sessions and assisting with data entry and data management.
Institutional review board approval for the project was received from the Human Subjects Committee at the University of Kansas Medical Center.
The primary findings were presented as a poster presentation at the American Diabetes Association's 74 Scientific Sessions; June 13–17, 2014; San Francisco, California. Preliminary results of this project also were presented at the 2014 Combined Sections Meeting of the American Physical Therapy Association; February 4–6, 2014; Las Vegas, Nevada.
This work was supported by Clinical and Translational Science Award (CTSA) program grants from the National Center for Advancing Translational Sciences (NCATS), awarded to the University of Kansas Medical Center for Frontiers: The Heartland Institute for Clinical and Translational Research UL1TR000001 and TL1TR000120 (for M.Y.). Support also was provided by grants T32HD057850 (for L.J.D.) and K01HD067318 (for S.A.B.) from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, NCATS, or the National Institutes of Health.
ClinicalTrials.gov trial registration: NCT01764373.
- Received March 11, 2014.
- Accepted September 24, 2014.
- © 2015 American Physical Therapy Association
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