Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial
Objectives To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high risk people living at home.
Design Three arm, randomised parallel trial; assessments at baseline and after six and 12 months. Randomisation done by computer generated random blocks, stratified by sex and fall history and concealed by an independent secure website.
Setting Residents in metropolitan Sydney, Australia.
Participants Participants aged 70 years or older who had two or more falls or one injurious fall in past 12 months, recruited from Veteran’s Affairs databases and general practice databases. Exclusion criteria were moderate to severe cognitive problems, inability to ambulate independently, neurological conditions that severely influenced gait and mobility, resident in a nursing home or hostel, or any unstable or terminal illness that would affect ability to do exercises.
Interventions Three home based interventions: Lifestyle integrated Functional Exercise (LiFE) approach (n=107; taught principles of balance and strength training and integrated selected activities into everyday routines), structured programme (n=105; exercises for balance and lower limb strength, done three times a week), sham control programme (n=105; gentle exercise). LiFE and structured groups received five sessions with two booster visits and two phone calls; controls received three home visits and six phone calls. Assessments made at baseline and after six and 12 months.
Main outcome measures Primary measure: rate of falls over 12 months, collected by self report. Secondary measures: static and dynamic balance; ankle, knee and hip strength; balance self efficacy; daily living activities; participation; habitual physical activity; quality of life; energy expenditure; body mass index; and fat free mass.
Results After 12 months’ follow-up, we recorded 172, 193, and 224 falls in the LiFE, structured exercise, and control groups, respectively. The overall incidence of falls in the LiFE programme was 1.66 per person years, compared with 1.90 in the structured programme and 2.28 in the control group. We saw a significant reduction of 31% in the rate of falls for the LiFE programme compared with controls (incidence rate ratio 0.69 (95% confidence interval 0.48 to 0.99)); the corresponding difference between the structured group and controls was non-significant (0.81 (0.56 to 1.17)). Static balance on an eight level hierarchy scale, ankle strength, function, and participation were significantly better in the LiFE group than in controls. LiFE and structured groups had a significant and moderate improvement in dynamic balance, compared with controls.
Conclusions The LiFE programme provides an alternative to traditional exercise to consider for fall prevention. Functional based exercise should be a focus for interventions to protect older, high risk people from falling and to improve and maintain functional capacity.
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ASBMR Task Force report on secondary fracture prevention released
Fragility fractures are common, affecting almost one in two older women and one in three older men. Every fragility fracture signals increased risk of future fractures as well as risk of premature mortality. Despite the major health care impact worldwide, currently there are few systems in place to identify and “capture” individuals after a fragility fracture to ensure appropriate assessment and treatment (according to national guidelines) to reduce future fracture risk and adverse health outcomes. The Task Force reviewed the current evidence about different systematic interventional approaches, their logical background, as well as the medical and ethical rationale. This included reviewing the evidence supporting cost-effective interventions and developing a toolkit for reducing secondary fracture incidence. This report presents this evidence for cost-effective interventions versus the human and health care costs associated with the failure to address further fractures. In particular, it summarizes the evidence for various forms of Fracture Liaison Service as the most effective intervention for secondary fracture prevention. It also summarizes the evidence that certain interventions, particularly those based on patient and/or community-focused educational approaches, are consistently, if unexpectedly, ineffective. As an international group, representing 36 countries throughout Asia-Pacific, South America, Europe, and North America, the Task Force reviewed and summarized the international data on barriers encountered in implementing risk-reduction strategies. It presents the ethical imperatives for providing quality of care in osteoporosis management. As part of an implementation strategy, it describes both the quality improvement methods best suited to transforming care and the research questions that remain outstanding. The overarching outcome of the Task Force’s work has been the provision of a rational background and the scientific evidence underpinning secondary fracture prevention and stresses the utility of one form or another of a Fracture Liaison Service in achieving those quality outcomes worldwide.
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A Few Hours of Weekly Exercise May Help Women’s Bones
Study found effect on proteins involved with bone growth in pre-menopausal women
Engaging in more than two hours of physical activity per week appears to help pre-menopausal women maintain healthy bones, new research suggests. The finding is based on the impact that even small amounts of exercise seem to have on curtailing the production of a protein that impedes bone growth, while at the same time increasing the activity of another protein that promotes bone formation. The study will appear in the October issue of the Journal of Clinical Endocrinology and Metabolism.
“Physical activity is good for bone health and results in lowering sclerostin — a known inhibitor of bone formation — and enhancing IGF-1 levels, a positive effector on bone health,” study author Mohammed-Salleh Ardawi, a professor at the Center of Excellence for Osteoporosis Research and the faculty of medicine at King Abdulaziz University in Saudi Arabia, said in a journal news release.
The authors note that sclerostin, a hormone, works by migrating to bone surfaces, where it impedes bone cell creation. IGF-1 is shorthand for insulin-like growth factor-1, a hormone that promotes growth. For this finding, researchers tracked 120 pre-menopausal women for an eight-week period. About half of the women were engaged in a supervised physical-activity routine, while the other half were not. Women who had participated in more than two hours of activity per week were found to have “significantly” lower sclerostin levels and higher IGF-1 levels.
“Physical-activity training is conceptually simple and inexpensive, and can serve practical purposes including reducing the risk of low bone mass and osteoporosis, and, consequently, fractures,” Ardawi said. “Our study found that even minor changes in physical activity were associated with clear effects on serum levels of sclerostin, IGF-1 and bone-turnover markers.”
For more on exercise and bone health, visit the U.S. National Institutes of Health.
Low Vitamin D Levels May Raise Death Risk in Older Adults: Study
Although cause and effect not proven, frail seniors appeared most vulnerable
Older adults with low vitamin D levels — especially those who are frail — have an increased risk of death.
That’s the finding of Oregon State University researchers who analyzed data from a survey of more than 4,300 U.S. adults older than 60.
Those with low vitamin D levels had a 30 percent greater risk of death during the study period than those with higher levels. Frail people had more than double the risk of death than those who were not frail. And those who were both frail and had low vitamin D levels were three times more likely to die than those who were not frail and had higher vitamin D levels.
The study was published online recently in the European Journal of Clinical Nutrition.
“What this really means is that it is important to assess vitamin D levels in older adults, and especially among people who are frail,” lead author and nutritional epidemiologist Ellen Smit said in a university news release. “Older adults need to be screened for vitamin D.” The researchers could not determine whether low vitamin D levels contributed to frailty or if frail people had low vitamin D levels due to health problems, but that may not be important, the researchers said.
“If you have both, it may not really matter which came first because you are worse off and at greater risk of dying than other older people who are frail and who don’t have low vitamin D,” Smit said. “This is an important finding because we already know there is a biological basis for this,” she concluded. “Vitamin D impacts muscle function and bones, so it makes sense that it plays a big role in frailty.”
According to the news release, about 70 percent of Americans and up to 1 billion people worldwide have insufficient levels of vitamin D, which the body produces in response to sun exposure. Other sources of vitamin D include certain foods and supplements. Although the study found an association between vitamin D levels and death risk in older adults, it did not prove a cause-and-effect relationship.
The Harvard School of Public Health has more about vitamin D and health.
Objective Vitamin D deficiency and polypharmacy are common in the elderly. However, knowledge on the associations between the use of specific medicines and serum 25-hydroxyvitamin D (25(OH)D) is limited. The aim of this study was to (better) define the associations between the use of specific medicines and serum 25(OH)D.
Methods Two different cohorts (1995/1996 and 2002/2003) from the Longitudinal Aging Study Amsterdam (LASA) were used for cross-sectional analyses. LASA is based on an age and sex-stratified random sample of the Dutch older population. Study participants were aged 65–88 years in the first cohort (n=1301) and 55–65 years in the second cohort (n=736). Serum 25(OH)D of users of several groups of medicines were compared with levels of non-users using multiple linear regression analysis.
Results Of all participants, 75.4% (first cohort) and 61.1% (second cohort) were using at least one medicine. In both cohorts, the number of medicines was associated with lower serum 25(OH)D. In the first cohort, after adjustment for confounding, users of any kind of medicine, loop diuretics and inhaled corticosteroids (only men) had respectively 4.4?nmol/l (P<0.01), 4.7?nmol/l (P=0.04) and 7.3?nmol/l (P=0.02) lower serum 25(OH)D than non-users. In the second cohort, the use of oral antidiabetics, calcium-channel blockers and angiotensin-converting enzyme inhibitors was associated with respectively 7.4?nmol/l (P=0.04), 7.7?nmol/l (P=0.01) and 7.6?nmol/l (P<0.01) lower serum 25(OH)D.
Conclusions These data show that users of several medicines have lower serum 25(OH)D than non-users. Vitamin D supplementation may be considered in patients with chronic use of medicines.
The Endocrine Society Recommends Patient-Centered Approach to
Long-Term Bisphosphonate Use for the Treatment of Osteoporosis
A review of the May 2012 FDA Analysis
May 16, 2012
Bisphosphonates are highly effective agents for the treatment of osteoporosis and prevention of fractures. Recently, concerns have been raised regarding the optimal exposure to these drugs because of long-term safety issues such as atypical femur fractures and osteonecrosis of the jaw although it is unclear what the relationship is between these rare events and bisphosphonate use.
In an article published in the New England Journal of Medicine’s Perspective section on May 9, 2012 that received widespread media coverage, Whitaker and colleagues at the Food and Drug Administration (FDA) present data from three extension trials of commonly used bisphosphonates (alendronate, risedronate, and zoledronic acid) regarding the reduction in fracture risk beyond that shown in the initial 4-5 year registration trials of these drugs (1). Their analysis showed that stopping bisphosphonate therapy led to a modest decline in femoral neck bone density in the first 1-2 years following cessation of treatment with stabilization thereafter. Lumbar spine BMD continued to increase despite therapy being discontinued. The FDA found similar rates of overall vertebral and non-vertebral fracture rates in those treated up to 10 years compared to those who were switched to placebo during the extension phase in all three trials, thus raising concern regarding the benefit of long-term bisphosphonate therapy for osteoporosis.
However, an accompanying Perspective in the same issue of the New England Journal of Medicine by Black and colleagues parses out the data for vertebral and non-vertebral fracture risk separately rather than using a composite of both fractures together (2). Their rationale for doing so was based on the different pathogenesis and responses to treatment at these sites. Black and colleagues found benefit for continuation of bisphosphonate therapy in some higher risk subgroups, particularly with respect to prevention of vertebral fractures.
Despite differences in methodology employed in the two papers, the FDA and Black analyses agree on many points. Both note that the few extension trials looking at long-term bisphosphonate use are limited by problems with statistical power, selection bias, sample size, and timing issues. They agree that bisphosphonates may be safely discontinued in some patients without compromising therapeutic gains. Both also agree that decisions to continue treatment must be based on individual assessment of risks and benefits and on patient preference. Moreover, both papers state that not all bisphosphonates are alike, so recommendations to discontinue bisphosphonates should be based on the specific drug.
Black et al. go on to provide a therapeutic algorithm for clinicians based on the current limited evidence summarized as follows:
- Patients with bone density T-scores of -2.5 or lower at the femoral neck after 3 to 5 years of treatment are at the highest risk for vertebral fractures and appear to benefit most from continuation of bisphosphonates.
- Patients with an existing vertebral fracture and T-scores up to ?2.0 may also benefit from continued therapy.
- Patients with femoral neck T-scores above ?2.0 have low risk of vertebral fractures and are unlikely to benefit from continued treatment after 3-5 years.
The Endocrine Society is concerned that a superficial reading of the FDA analysis will result in an inappropriate abandonment of bisphosphonates for both short- and long-term use in patients with osteoporosis. Therefore, the Society urges its members to engage in a patient-specific dialogue about the appropriateness of long-term bisphosphonate use. Furthermore, healthcare professionals should follow the package insert’s recommendations when prescribing bisphosphonates. Patients should continue taking their medication unless advised to stop by their health care provider. The Society supports continued research in this area to better clarify the short- and long-term benefits, and risks of bisphosphonates and other drugs used in patients with osteoporosis.
For questions, please contact Stephanie Kutler, Director of Government Affairs, at firstname.lastname@example.org.
- Whitaker M., Guo J., Kehoe T., Benson G. 10.1056/NEJMp1202619
2. Black D.M., Bauer D.C., Schwartz A.V., Cummings S.R., Rosen C.J. 10.1056/NEJMp1202623
Serum levels of C-reactive protein (CRP) are inversely and independently associated with bone mineral density (BMD) in the general US population according to a study published online in the journal Arthritis & Rheumatism. After examining data on some 10,475 adults aged 20 and over, researchers found “in both men and women…a significant, inverse dose-dependent association between CRP quintiles and BMD at the extremities. Also, in women but not men, there was a significant, inverse dose-dependent association between CRP quintiles and BMD at the lumbar spine.”