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IIR 06-252 – HSR&D Study

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IIR 06-252
Enhancing fitness in older overweight vets with impaired fasting glucose
Miriam C. Morey PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: July 2008 - June 2011

BACKGROUND/RATIONALE:
Rates of diabetes continue to increase in this country and are responsible for a disproportionate utilization of health care expenditures. Increasing trends in yearly prevalence rates of diabetes suggest that prediabetes is becoming more common among users of VA for health care. Obesity also continues to rise in VA. The VA has aggressively addressed increases in diabetes, prediabetes, and obesity with implementation of diabetes education and weight management programs and performance measures aimed at optimizing health care in these patients. The VA National Center for Health Promotion (NCP) has instituted several initiatives aimed at promoting physical activity (PA) but implementations of these initiatives vary widely depending upon personnel, equipment, and facilities availability. Building on a successful home-based PA counseling research program, we developed the Enhanced Fitness Study.

OBJECTIVE(S):
The primary objective of the Enhanced Fitness study was to improve glycemic control in older, overweight adults with impaired fasting glucose receiving primary care at the Durham VA. We hypothesized that individuals receiving intensive PA counseling would have significantly improved insulin action, as indicated by fasting insulin, fasting glucose, and by the calculated homeostasis model assessment (HOMA) of insulin resistance, than individuals receiving usual primary care (UC). Other outcomes included comparisons between intensive PA counseling against UC for secondary outcomes of glycemic control (Hemoglobin A1c, metabolic syndrome score), PA, physical function, and health related quality of life.

Our study design included an adaptive randomization which reallocated individuals to higher or lower doses of telephone counseling at three months. This design would allow us to compare costs and outcomes based on different levels of telephone counseling.

Finally we proposed a "train the trainers" approach to teach PA counseling methods developed for this study to other health care practitioners.

METHODS:
We employed a randomized clinical trial with an adaptive randomization design. Veterans ages 60 and over, not regularly exercising, with a body mass index between 25 and 45, and a fasting glucose between 100 and 125 mg/dl were included in this study (n=302). They were randomized to receive high intensity PA counseling or UC. The PA counseling consisted of: (1) in-person baseline counseling, (2) primary care provider endorsement at next clinic visit, (3) telephone counseling for one-year, (4) automated telephone primary care provider endorsement four times during the year, and (5) tailored quarterly mailed reports. A MOVE! consult was submitted for study participants in both arms. At three months, individuals in the PA counseling arm were randomly reassigned to higher or lower doses of PA counseling for the remainder of the study.

FINDINGS/RESULTS:
The average age of the sample was 67 with a range of 60 to 89. Forty-six percent of the sample had only a high school degree or less. The most frequently reported comorbidities were hypertension (72%) and arthritis (52%). Of 302 patients randomized, 262 (86.8%) of the sample completed the 12-month follow-up visit.

There were no significant differences between PA counseling and UC over time for any of the glycemic indicators. Both groups had declines over time of approximately 6% in fasting blood glucose, p< 0.001. These declines were not sufficient to affect the change in HOMA scores due to fluctuations in insulin over time. HbA1c remained stable throughout the year.

Walking and other endurance physical activity increased significantly over time for the PA counseling group from an average 73 minutes per week at baseline to an average 133 minutes per week at 12-months (+82%) in comparison to the UC group whose endurance PA remained constant from 115 minutes per week at baseline to 112 minutes per week at 12-months, p<0.0001 for between group difference controlling for baseline PA. The prevalence of individuals meeting the goal of 150 minutes of endurance exercise increased in the PA counseling group over time from 16% to 42% in contrast to UC whose prevalence of individuals meeting the 150 minute per week marker was stable over time, OR=1.65(1.08,2.53) for meeting or not meeting goals between groups. Both groups increased strength training activities over time with no between group differences noted. No changes were noted for other secondary outcomes relating to health quality of life or physical function.


IMPACT:
The JAMA recently published a meta-analysis of the impact of home-based versus structured exercise in Type II diabetes. They concluded that PA counseling alone did not have a positive impact on their primary outcome of HemA1C. Our study confirms this finding in a VA population and points towards the higher chronic disease burden that Veterans possess as a possible impediment to achieving evidence-based levels of PA necessary to obtain certain health benefits. Further research is needed to optimize health promoting strategies for PA for Veterans.


PUBLICATIONS:

Journal Articles

  1. Hall KS, Beckham JC, Bosworth HB, Sloane R, Pieper CF, Morey MC. PTSD is negatively associated with physical performance and physical function in older overweight military Veterans. Journal of rehabilitation research and development. 2014 May 1; 51(2):285-95.
  2. Povsic TJ, Sloane R, Zhou J, Pieper CF, Pearson MP, Peterson ED, Green JB, Cohen HJ, Morey MC. Lower levels of circulating progenitor cells are associated with low physical function and performance in elderly men with impaired glucose tolerance: a pilot substudy from the VA Enhanced Fitness trial. The journals of gerontology. Series A, Biological sciences and medical sciences. 2013 Dec 1; 68(12):1559-66.
  3. Povsic TJ, Sloane R, Green JB, Zhou J, Pieper CF, Pearson MP, Peterson ED, Cohen HJ, Morey MC. Depletion of circulating progenitor cells precedes overt diabetes: a substudy from the VA enhanced fitness trial. Journal of diabetes and its complications. 2013 Nov 1; 27(6):633-6.
  4. Morey MC, Pieper CF, Edelman DE, Yancy WS, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Hall KS, Pearson MP, Taylor GA. Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus. Journal of the American Geriatrics Society. 2012 Sep 1; 60(9):1655-62.
  5. Turer CB, Bernstein IH, Edelman DE, Yancy WS. Low HDL predicts differential blood pressure effects from two weight-loss approaches: a secondary analysis of blood pressure from a randomized, clinical weight-loss trial. Diabetes, Obesity & Metabolism. 2012 Apr 1; 14(4):375-8.
  6. Hall KS, Pieper CF, Edelman DE, Yancy WS, Green JB, Lum H, Peterson MJ, Sloane R, Cowper PA, Bosworth HB, Huffman KM, Cavanaugh JT, Chapman JG, Pearson MP, Howard TA, Ekelund CC, McCraw BL, Burrell JB, Taylor GA, Morey MC. Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study. Translational behavioral medicine. 2011 Nov 1; 1(4):573-587.
Conference Presentations

  1. Pearson M, Bosworth HB, Morey MC. Does Enrollment in a Physical Activity Clinical Trial Increase the level of Physical Activity in Control Arm Participants? Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2009 Nov 20; Atlanta, GA.
  2. McCraw BL, Pearson M, Bosworth HB, Morey MC. Comparison of Facility-Based vs. Home-Based Exercise on Changes in Usual Gait Speed in Veterans 70 years or older. Poster session presented at: Gerontological Society of America Annual Scientific Meeting; 2009 Nov 19; Atlanta, GA.


DRA: Diabetes and Related Disorders, Health Systems, Aging, Older Veterans' Health and Care
DRE: Treatment - Observational, Prevention, Treatment - Efficacy/Effectiveness Clinical Trial
Keywords: Exercise, Obesity, Outcomes, Outcomes - Patient, Self-Care
MeSH Terms: none

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