Economic Analysis of Primary Care-Based Physical Activity Counseling in Older Men: The VA-LIFE Trial.

OBJECTIVES: To perform an economic evaluation of a primary care-based physical activity counseling intervention that improved physical activity levels and rapid gait speed in older veterans. DESIGN: Secondary objective of randomized trial that assessed the effect of exercise counseling (relative to usual care) on physical performance, physical activity, function, disability, and medical resource use and cost. SETTING: Veterans Affairs Medical Center, Durham, North Carolina. PARTICIPANTS: Male veterans aged ≥70 years (n = 398). INTERVENTION: An experienced health counselor provided baseline in-person exercise counseling, followed by telephone counseling at 2, 4, and 6 weeks, and monthly thereafter through one year. Each participant's primary care physician provided initial endorsement of the intervention, followed by monthly automated telephone messages tailored to the patient. Individualized progress reports were mailed quarterly. MEASUREMENTS: Intervention costs were assessed. Health care resource use and costs were estimated from enrollment through one year follow-up. The incremental cost of achieving clinically significant changes in major trial endpoints was calculated. RESULTS: The total direct cost of the intervention per participant was $459, 85% of which was counselor effort. With overhead, program cost totaled $696 per participant. Medical costs during follow-up reached $10,418 with the intervention, versus $12,052 with usual care (difference = -$1,634 (95% confidence interval = -$4,683 to $1,416; P = .29)). Expressed in terms of short-term clinical outcomes, the intervention cost $4,971 per additional patient reaching target exercise levels, or $4,640 per patient achieving a clinically significant change in rapid gait speed. CONCLUSION: Improvements in physical activity and rapid gait speed in the physical activity counseling group were obtained at a cost that represents a small fraction of patients' annual health care costs.

Endothelial Progenitor Cell Levels Predict Future Physical Function: An Exploratory Analysis From the VA Enhanced Fitness Study.

BACKGROUND: Levels of circulating progenitor cells (CPCs) are depleted with aging and chronic injury and are associated with level of physical functioning; however, little is known about the correlation of CPCs with longer-term measures of physical capabilities. We sought to determine the association of CPCs with future levels of physical function and with changes in physical function over time. METHODS: CPCs were measured in 117 participants with impaired glucose tolerance in the Enhanced Fitness clinical trial based on the cell surface markers CD34 and CD133 and aldehyde dehydrogenase (ALDH) activity at baseline, 3 months, and 12 months. Physical function was assessed using usual and rapid gait speed, 6-minute walk distance, chair stand time, and SF-36 physical functioning score and reassessed at 3 and 12 months after clinical intervention. RESULTS: Higher baseline levels of CD133(+), CD34(+), CD133(+)CD34(+), and ALDH(br) were each highly predictive of faster gait speed and longer distance walked in 6 minutes at both 3 and 12 months. These associations remained robust after adjustment for age, body mass index, baseline covariates, and inflammation and were independent of interventions to improve physical fitness. Further, higher CPC levels predicted greater improvements in usual and rapid gait speed over 1 year. CONCLUSIONS: Baseline CPC levels are associated not only with baseline mobility but also with future physical function, including changes in gait speed. These findings suggest that CPC measurement may be useful as a marker of both current and future physiologic aging and functional decline.

Differences between completely physically inactive and low active older men and their response to an exercise intervention: the Veterans LIFE study.

BACKGROUND: Physical activity interventions typically do not report behavioral changes in activity sub-groups. The aim of this study was to compare baseline differences and changes in physical activity between truly physically inactive men and low active men enrolled in a twelve-month, home-based physical activity intervention. METHODS: Veterans with a mean age of 77.6 years were randomized to either a physical activity intervention or usual care. Measures included self-reported physical activity, physical function, and physical performance. RESULTS: At baseline, the physically inactive group reported more symptoms and poorer functioning than the low active group. At 12 months, physically inactive men randomized to the intervention group increased their physical activity to an average of 73.3 minutes per week. Physically inactive individuals randomized to the control group were eight times more likely to remain inactive compared to the low active group. CONCLUSIONS: Completely physically inactive older men can markedly increase physical activity levels with a long-term intervention. Without such intervention, the likelihood of this group remaining inactive is eightfold.

Depletion of circulating progenitor cells precedes overt diabetes: a substudy from the VA enhanced fitness trial.

BACKGROUND: One theory of aging and disease development is that chronic injury (pathology) results in activation of regenerative processes and initial repair, with overt disease arising only after exhaustion of reparative capability leads to inadequate repair. While depletion of circulating progenitor cells (CPCs) has been noted in diabetes, the degree to which CPC depletion predates and is associated with propensity to develop overt disease is unclear. METHODS: The Enhanced Fitness trial enrolled overweight/obese (body mass index >25) sedentary patients with glucose intolerance but without overt diabetes. Baseline CPCs were measured in 129 patients based on the cell surface markers CD34, CD133, and aldehyde dehydrogenase (ALDH) activity. HgbA1C, fasting insulin and glucose levels, and HOMA calculations were ascertained. RESULTS: Lower counts of early angiogenic CPCs identified as CD34(+), CD34(+)CD133(+), and ALDH-bright (ALDH(br)) cells were associated with impairments in glucose homeostasis as reflected by HgbA1C, but not fasting insulin, glucose, or HOMA-IR. These associations remained when corrected for age and cardiovascular risk factors. CONCLUSIONS/INTERPRETATION: The numbers of CD34(+) and ALDH(br) CPCs were significantly lower in patients with impaired glucose tolerance. Depletion of reparative capacity as reflected by loss of CPCs may presage overt disease as exemplified in this pre-diabetes model.

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.

BACKGROUND: Aging is marked by a decline in physical function. Although the biological underpinnings for this remain unclear, loss of regenerative capacity has been proposed as one cause of the loss of physical function that occurs over time. The quantity of circulating progenitor cells (CPCs) may be one reflection of regenerative capability. We sought to determine whether certain specific CPC subpopulations were associated with physical function. METHODS: Baseline CPCs were measured in 129 randomized participants in the Enhanced Fitness clinical trial based on the cell surface markers CD34, CD133, CD146, and CD14 and aldehyde dehydrogenase (ALDH) activity. Physical function was assessed using usual and rapid gait speed, 6-minute walk distance, chair stand time, and balance time. RESULTS: Low counts of early angiogenic CPCs identified as CD34(+), CD34(+)CD133(+), and ALDH-bright (ALDH(br)) cells were associated with low usual gait speed (p < .005, p < .001, and p < .007), rapid gait speed (p < .001, p < .003, and p < .001), and 6-minute walking distance (all comparisons p < .001), and longer time required to complete five chair stands (p < .006, p < .002, and p < .004). CPC counts of mature endothelial or monocytic markers were not associated with physical function. CONCLUSIONS: The numbers of CD34(+) and ALDH(br) CPCs are significantly lower in patients with impaired physical function. Further studies are needed to determine the underlying causes for this association.

Enhanced fitness: a randomized controlled trial of the effects of home-based physical activity counseling on glycemic control in older adults with prediabetes mellitus.

OBJECTIVES: To determine whether a home-based multicomponent physical activity counseling (PAC) intervention is effective in reducing glycemic measures in older outpatients with prediabetes mellitus. DESIGN: Controlled clinical trial. SETTING: Primary care clinics of the Durham Veterans Affairs (VA) Medical Center between September 29, 2008, and March 25, 2010. PARTICIPANTS: Three hundred two overweight (body mass index 25-45 kg/m(2) ), older (60-89) outpatients with impaired glucose tolerance (fasting blood glucose 100-125 mg/dL, glycosylated hemoglobin (HbA1c) <7%) randomly assigned to a PAC intervention group (n = 180) or a usual care control group (n = 122). INTERVENTION: A 12-month, home-based multicomponent PAC program including one in-person baseline counseling session, regular telephone counseling, physician endorsement in clinic with monthly automated encouragement, and customized mailed materials. All study participants, including controls, received a consultation in a VA weight management program. MEASUREMENTS: The primary outcome was a homeostasis model assessment of insulin resistance (HOMA-IR), calculated from fasting insulin and glucose levels at baseline and 3 and 12 months. HbA1c was the secondary indicator of glycemic control. Other secondary outcomes were anthropometric measures and self-reported physical activity, health-related quality of life, and physical function. RESULTS: There were no significant differences between the PAC and control groups over time for any of the glycemic indicators. Both groups had small declines over time of approximately 6% in fasting blood glucose (P < .001), and other glycemic indicators remained stable. The declines in glucose were not sufficient to affect the change in HOMA-IR scores due to fluctuations in insulin over time. Endurance physical activity increased significantly in the PAC group (P < .001) and not in the usual care group. CONCLUSION: Home-based telephone counseling increased physical activity levels but was insufficient to improve glycemic indicators in older outpatients with prediabetes mellitus.

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.

Individuals diagnosed with impaired glucose tolerance (i.e., prediabetes) are at increased risk for developing diabetes. We proposed a clinical trial with a novel adaptive randomization designed to examine the impact of a home-based physical activity (PA) counseling intervention on metabolic risk in prediabetic elders. This manuscript details the lessons learned relative to recruitment, study design, and implementation of a 12-month randomized controlled PA counseling trial. A detailed discussion on how we responded to unforeseen challenges is provided. A total of 302 older patients with prediabetes were randomly assigned to either PA counseling or usual care. A novel adaptive design that reallocated counseling intensity based on self-report of adherence to PA was initiated but revised when rates of non-response were lower than projected. This study presents baseline participant characteristics and discusses unwelcome adaptations to a highly innovative study design to increase PA and enhance glucose metabolism when the best-laid plans went awry.

The Veterans Learning to Improve Fitness and Function in Elders Study: a randomized trial of primary care-based physical activity counseling for older men.

OBJECTIVES: To determine the effects of primary care-based, multicomponent physical activity counseling (PAC) promoting physical activity (PA) guidelines on gait speed and related measures of PA and function in older veterans. DESIGN: Randomized controlled trial. SETTING: Veterans Affairs Medical Center of Durham, North Carolina. PARTICIPANTS: Three hundred ninety-eight male veterans aged 70 and older. INTERVENTION: Twelve months of usual care (UC) or multicomponent PAC consisting of baseline in-person and every other week and then monthly telephone counseling by a lifestyle counselor, one-time clinical endorsement of PA, monthly automated telephone messaging from the primary care provider, and quarterly tailored mailings of progress in PA. MEASUREMENTS: Gait speed (usual and rapid), self-reported PA, function, and disability at baseline and 3, 6, and 12 months. RESULTS: Although no between-group differences were noted for usual gait speed, rapid gait speed improved significantly more for the PAC group (1.56 +/- 0.41 m/s to 1.68 +/- 0.44 m/s) than with UC (1.57 +/- 0.40 m/sec to 1.59 +/- 0.42 m/sec, P=.04). Minutes of moderate/vigorous PA increased significantly in the PAC group (from 57.1 +/- 99.3 to 126.6 +/- 142.9 min/wk) but not in the UC group (from 60.2 +/- 116.1 to 69.6 +/- 116.1 min/wk, P<.001). Changes in other functional/disability outcomes were small. CONCLUSION: In this group of older male veterans, multicomponent PA significantly improved rapid gait and PA. Translation from increased PA to overall functioning was not observed. Integration with primary care was successful.

Effect of physical activity guidelines on physical function in older adults.

OBJECTIVES: To determine whether elderly people who meet national guidelines have higher physical function (PF) scores than those who do not and the effect on functional trajectory when physical activity (PA) levels change from above to below this threshold, or vice versa. DESIGN: Pooled data. SETTING: Two 6-month randomized controlled trials aimed at increasing PA in adults. PARTICIPANTS: Adults aged 65 to 94 (N=357). INTERVENTION: PA counseling over the telephone and through mailed materials. MEASUREMENTS: Self-reported PA dichotomized at 150 minutes/week and PF using the Medical Outcomes Study 36-item Short Form Questionnaire PF subscale. RESULTS: At baseline, individuals reporting 150 minutes or more of moderate PA/week had mean PF scores that were 20.3 points higher than those who did not (P<.001). Change in PA minutes from above threshold to below threshold or from below threshold to above threshold from baseline to 6 months resulted in an average change in PF of -11.18 (P<.001) and +5.10 (P=.05), respectively. CONCLUSION: These findings suggest that PA is an important predictor of functional status. Older sedentary adults can improve PF by meeting recommended PA levels. Conversely, dropping below recommended PA levels has a deleterious effect on PF. Given the importance of PF in maintenance of independence and quality of life in older adults, adherence to recommended PA guidelines should be endorsed.