Sharon L. Tennstedt

Adverse events associated with testosterone administration.

BACKGROUND Testosterone supplementation has been shown to increase muscle mass and strength in healthy older men. The safety and efficacy of testosterone treatment in older men who have limitations in mobility have not been studied. METHODS Community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter) or a free serum testosterone level of less than 50 pg per milliliter (173 pmol per liter) were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group. RESULTS A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6-month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load. CONCLUSIONS In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy. (ClinicalTrials.gov number, NCT00240981.)

Retropubic versus Transobturator Midurethral Slings for Stress Incontinence

BACKGROUND Midurethral slings are increasingly used for the treatment of stress incontinence, but there are limited data comparing types of slings and associated complications. METHODS We performed a multicenter, randomized equivalence trial comparing outcomes with retropubic and transobturator midurethral slings in women with stress incontinence. The primary outcome was treatment success at 12 months according to both objective criteria (a negative stress test, a negative pad test, and no retreatment) and subjective criteria (self-reported absence of symptoms, no leakage episodes recorded, and no retreatment). The predetermined equivalence margin was +/-12 percentage points. RESULTS A total of 597 women were randomly assigned to a study group; 565 (94.6%) completed the 12-month assessment. The rates of objectively assessed treatment success were 80.8% in the retropubic-sling group and 77.7% in the transobturator-sling group (3.0 percentage-point difference; 95% confidence interval [CI], -3.6 to 9.6). The rates of subjectively assessed success were 62.2% and 55.8%, respectively (6.4 percentage-point difference; 95% CI, -1.6 to 14.3). The rates of voiding dysfunction requiring surgery were 2.7% in those who received retropubic slings and 0% in those who received transobturator slings (P=0.004), and the respective rates of neurologic symptoms were 4.0% and 9.4% (P=0.01). There were no significant differences between groups in postoperative urge incontinence, satisfaction with the results of the procedure, or quality of life. CONCLUSIONS The 12-month rates of objectively assessed success of treatment for stress incontinence with the retropubic and transobturator approaches met the prespecified criteria for equivalence; the rates of subjectively assessed success were similar between groups but did not meet the criteria for equivalence. Differences in the complications associated with the two procedures should be discussed with patients who are considering surgical treatment for incontinence. (ClinicalTrials.gov number, NCT00325039.)

Ten-Year Effects of the Advanced Cognitive Training for Independent and Vital Elderly Cognitive Training Trial on Cognition and Everyday Functioning in Older Adults

To determine the effects of cognitive training on cognitive abilities and everyday function over 10 years.

ACTIVE: a cognitive intervention trial to promote independence in older adults.

The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) trial is a randomized, controlled, single-masked trial designed to determine whether cognitive training interventions (memory, reasoning, and speed of information processing), which have previously been found to be successful at improving mental abilities under laboratory or small-scale field conditions, can affect cognitively based measures of daily functioning. Enrollment began during 1998; 2-year follow-up will be completed by January 2002. Primary outcomes focus on measures of cognitively demanding everyday functioning, including financial management, food preparation, medication use, and driving. Secondary outcomes include health-related quality of life, mobility, and health-service utilization. Trial participants (n = 2832) are aged 65 and over, and at entry into the trial, did not have significant cognitive, physical, or functional decline. Because of its size and the carefully developed rigor, ACTIVE may serve as a guide for future behavioral medicine trials of this nature.

Effects of a computer-based, telephone-counseling system on physical activity

BACKGROUND There is increasing interest in developing interventions to promote physical activity (PA) that do not involve face-to-face contact with health professionals. We developed a fully automated PA counseling system (telephone-linked communication, TLC-PA) that was delivered via telephone. DESIGN A randomized, controlled trial with 298 adult, sedentary members (mean age, 45.9 years; 72% women; 45% white; and 45% African American) of a multi-site medical practice. The comparison group (TLC-Eat) received an automated intervention promoting healthy eating, which was also delivered via telephone. INTERVENTION The TLC-PA promoted moderate-intensity PA (MI-PA) based on the transtheoretical model of behavior change and social cognitive theory. The system was available to participants for 6 months. MAIN OUTCOMES Energy expenditure in MI-PA, proportion of participants who met recommendations for MI-PA, and motivational readiness for PA. MEASURES Self-reports of PA behavior and motivational readiness at baseline, 3 months, and 6 months. RESULTS At 3 months, intention-to-treat analyses showed that the TLC-PA group was more likely to meet recommendations for MI- or vigorous-intensity PA (VI-PA) compared to the TLC-Eat group (TLC-PA=26% vs TLC-Eat=19.6%, p=0.04). Among study completers, TLC-PA subjects reported significantly higher daily kilocalorie energy expenditure in MI-PA (2.3 kcal/kg/d vs 2.0 kcal/kg/d, p=0.02); a larger proportion met recommendations for MI- or VI-PA (31.2% vs 21.3%, p=0.02) and were in more advanced stages of motivational readiness than TLC-Eat subjects (TLC-PA=52.5% vs TLC-Eat=42.2%, p=0.04). Results were not maintained at 6 months. The proportion of TLC-PA users decreased significantly over the intervention period. CONCLUSIONS A fully automated counseling system had positive short-term effects on PA among sedentary adults. Lack of maintenance of effects may be due to a decrease in the number of participants who continued to use the system.

Prevalence of and Risk Factors for Urine Leakage in a Racially and Ethnically Diverse Population of Adults The Boston Area Community Health (BACH) Survey

Most epidemiologic studies of urine leakage in the United States report on women and White populations. In this study, the authors determined the prevalence of urine leakage across genders and racial/ethnic groups in a population-based sample of 5,506 adults aged 30-79 years and identified factors related to leakage within genders and racial/ethnic groups. The prevalence of weekly urine leakage was 8% overall, 10.4% in women, and 5.3% in men. White women (11.7%) were more likely than Black (9.4%) and Hispanic (7.3%) women to report weekly leakage and to report stress-type (35.4% vs. 9.4% and 14.5%, respectively) and urge-type (13.4% vs. 3.3% and 10.8%, respectively) leakage. Rates and leakage types for men did not vary by race/ethnicity. For women, central obesity, asthma, and arthritis increased the odds of weekly leakage. For men, the odds of leakage increased for Blacks and Whites at ages 50 and 60 years, respectively, and for Hispanics of higher social class. For both genders, various comorbid conditions, including heart disease, asthma, and depression, increased the odds of leakage in varying racial/ethnic groups. The authors conclude that types of and risk factors for urine leakage vary by gender and racial/ethnic group.

Physician-based physical activity counseling for middle-aged and older adults: A randomized trial.

Sedentary behavior among older adults increases risk for chronic diseases. Physicians in a primary care setting can play an important role in promoting physical activity adoption among their older patients. The Physically Active for Life (PAL) project was a randomized, controlled trial comparing the efficacy of brief physician-delivered physical activity counseling to usual care on self-reported physical activity levels. The physical activity counseling was based on the Transtheoretical Model of Change and social learning theory. Twenty-four community-based primary care medical practices were recruited into the study; 12 were randomized to the Intervention condition and 12 to the Control condition. Physicians in the Intervention practices received training in the delivery of brief physical activity counseling. Subjects in the Intervention practices (n=181) received brief activity counseling matched to their stage of motivational readiness for physical activity, a patient manual, a follow-up appointment with their physician to discuss activity counseling, and newsletter mailings. Subjects in the Control practices (n=174) received standard care. Measures of motivational readiness for physical activity and the Physical Activity Scale for the Elderly (PASE) were administered to subjects in both conditions at baseline, 6 weeks following their initial appointment, and at 8 months. Results showed that at the 6-week follow-up, subjects in the Intervention condition were more likely to be in more advanced stages of motivational readiness for physical activity than subjects in the Control condition. This effect was not maintained at the 8 month follow-up and the intervention did not produce significant changes in PASE scores. Results suggest that more intensive, sustained interventions may be necessary to promote the adoption of physical activity among sedentary, middle-aged, and older adults in primary care medical practices.

Effects of a Multicomponent Cognitive Behavioral Group Intervention on Fear of Falling and Activity Avoidance in Community-Dwelling Older Adults: Results of a Randomized Controlled Trial

OBJECTIVES: To evaluate the effects of a multicomponent cognitive behavioral intervention on fear of falling and activity avoidance in older adults.

Intensity and Correlates of Fear of Falling and Hurting Oneself in the Next Year Baseline Findings from a Roybal Center Fear of Falling Intervention

Fear of falling is highly prevalent and associated with restricted activity. To help inform design of interventions, the authors examined the correlates of this fear. Data came from baseline information on subjects in a community-based falls intervention study (N = 392). In a multivariate model, lower levels of fear of falling and hurting oneself in the next year were related to being younger, having higher levels of dysfunction, and having lower levels of perceived ability to manage falls, with the last two remaining significant even after controlling for generalized fearfulness. When analyzing specific domains of dysfunction, higher levels of fear of falling and hurting oneself in the next year were associated with higher levels of physical dysfunction. The findings lend support to the expanding awareness that fear of falling may imperil quality of life and suggest the importance of interventions aimed at enhancing ability to manage falls.

Tobacco use: a modifiable risk factor for dental disease among the elderly.

OBJECTIVES Because the public health literature contains few analytic studies of modifiable behavioral risk factors for dental disease among older community-dwelling populations, the New England Elders Dental Study was undertaken as an epidemiologic study of the oral health status of a representative sample of older adults living within the six New England states. METHODS Five dentists conducted comprehensive in-home oral health examinations on 1156 community-dwelling adults aged 70 and older to determine whether lifetime use of tobacco products was a significant risk factor for tooth loss, caries, and periodontal disease. RESULTS Among New England elders, tobacco use was more common among men (18.1%) than women (7.9%), with a combined rate of 12.3%. Further, 64.7% of men and 36.6% of women were previous tobacco users. Years of exposure to tobacco products was a statistically significant risk factor for tooth loss, coronal and root caries, and periodontal disease, regardless of other social and behavioral factors. CONCLUSIONS Lifelong tobacco use is a modifiable risk factor for poor dental health among older adults. Dental practitioners need to intervene with all their adult patients to discourage use of tobacco products for oral as well as general preventive health care.