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Effect of tiotropium/olodaterol on sedentary and active time in patients with COPD: post hoc analysis of the VESUTO® study.
Minakata, Y, Motegi, T, Ueki, J, Gon, Y, Nakamura, S, Anzai, T, Hirata, K, Ichinose, M
International journal of chronic obstructive pulmonary disease. 2019;:1789-1801
Abstract
BACKGROUND Patients with COPD are less physically active. This post hoc analysis of a randomized, double-blind, active-controlled, crossover trial assessed the efficacy of once-daily tiotropium/olodaterol combination therapy versus tiotropium monotherapy in Japanese patients with COPD. PATIENTS AND METHODS Patients were provided with a three-axis accelerometer to measure sedentary and active behavior defined as 1.0-1.5 metabolic equivalents (METs), ≥2.0 METs, and ≥3.0 METs, respectively. Of the 182 patients enrolled, 131 satisfied the conditions for the present analysis and were randomized to tiotropium monotherapy (n=62) or tiotropium/olodaterol combination therapy (n=69). RESULTS Tiotropium/olodaterol combination therapy significantly reduced the duration of 1.0-1.5 MET activity by 8.64 mins (p=0.040) and significantly increased the duration of ≥2.0 MET and ≥3.0 MET activity by 6.51 mins (p=0.017) and 2.60 mins (p=0.008), respectively, compared with tiotropium alone. Subgroup analyses showed that better lung function, milder dyspnea, and higher levels of physical activity at baseline were associated with reduced sedentary time and increased duration of physical activity. CONCLUSION Tiotropium/olodaterol combination therapy significantly reduced sedentary time and improved physical activity compared with tiotropium monotherapy. This trial was registered in ClinicalTrials.gov (NCT02629965).
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A study protocol of Older Person's Exercise and Nutrition Study (OPEN) - a sit-to-stand activity combined with oral protein supplement - effects on physical function and independence: a cluster randomized clinical trial.
Grönstedt, H, Vikström, S, Cederholm, T, Franzén, E, Seiger, Å, Wimo, A, Faxén-Irving, G, Boström, AM
BMC geriatrics. 2018;(1):138
Abstract
BACKGROUND Poor nutrition and age per see add to the development of sarcopenia, i.e. loss of muscle mass and strength, which contributes to increased risk of impaired activities of daily living (ADL) and reduced independence. Protein deficiency plays an important role in the development of sarcopenia. In order to increase the muscle mass protein intake should be combined with physical exercise. A daily physical activity, the sit-to-stand exercise, has been proven to decrease older persons' dependence in ADL. Our study aims to evaluate the effects of the sit-to-stand exercise in combination with a protein-rich nutritional supplement, on physical function and independence in frail nursing home residents. The resident's perceptions and experiences of the intervention and the staff's experiences of supporting the resident to complete the intervention will also be explored. METHODS The study is a two-arm cluster-randomized controlled trial which will be performed in nursing homes at two municipalities in Sweden. We will recruit 120 residents, age 75 or older and able to stand up from a seated position. Residents (n = 60) randomized to the intervention group will perform the sit-to-stand exercise at four occasions daily and will be offered a protein-rich oral supplement, twice a day. The intervention period will last for 12 weeks and measures of physical function, nutritional status, quality of life and health economy will be performed at baseline and at 12-weeks follow-up. The primary outcome will be the number of chair rises performed in 30 s. The control group will receive standard care. Data will be analysed by intention-to-treat analysis and with mixed effect models. During the last part of the intervention period individual interviews with the residents, on the topic of feasibility with the OPEN concept will be held. Likewise, focus-group-interviews with staff will be performed. DISCUSSION The residents' physical and mental health could be expected to improve. Even the work situation for staff could be positively affected. One innovative feature of the OPEN study is the simple intervention consisting of a basic daily activity that can be performed by several nursing home residents with the support of existing staff and available resources. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02702037.
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Comparison of a group-delivered and individually delivered lifestyle-integrated functional exercise (LiFE) program in older persons: a randomized noninferiority trial.
Jansen, CP, Nerz, C, Kramer, F, Labudek, S, Klenk, J, Dams, J, König, HH, Clemson, L, Becker, C, Schwenk, M
BMC geriatrics. 2018;(1):267
Abstract
BACKGROUND The Lifestyle-Integrated Functional Exercise (LiFE) program is effective in improving strength, balance, and physical activity (PA) while simultaneously reducing falls in older people by incorporating exercise activities in recurring daily tasks. However, implementing the original LiFE program includes substantial resource requirements. Therefore, as part of the LiFE-is-LiFE project, a group format (gLiFE) of the LiFE program has been developed, which will be tested regarding its noninferiority to the individually delivered LiFE in terms of PA-adjusted fall incidence and overall cost-effectiveness. METHODS In a multi-centre, single-blinded noninferiority trial, an envisaged sample of N = 300 participants (> 70 years; faller and/or confirmed falls risk; community-dwelling) will be randomized in either LiFE or gLiFE. Both groups will undergo the same strength and balance activities as well as PA promotion activities and habitualization strategies as described in the LiFE programme, however, based on different approaches of delivery: During the 6-month intervention phase, LiFE participants will receive seven home visits and two telephone calls; in gLiFE, the program will be delivered in seven group sessions and also two telephone calls. Main outcomes are a) fall incidence per PA and b) incremental cost-effectiveness ratio comparing costs and quality-adjusted life years between the two interventions. Secondary outcomes include PA behaviour, motor performance, health status, psychosocial status, program evaluation, and adherence. Measurements will be conducted at baseline, 6-month and 12-month follow-up; evaluation of intervention sessions and assessment of psychosocial variables related to execution and habitualization of LiFE activities will be made during the intervention period as well. DISCUSSION Compared to LiFE, we expect gLiFE to (a) reduce falls per PA by a similar rate; (b) be more cost-effective; (c) comparably enhance physical performance in terms of strength and balance as well as PA. By investigating the economic and societal benefit, this study will be of high practical relevance as noninferiority of gLiFE would facilitate large-scale implementation due to lower resource usage. This would result in better reach and increased accessibility, which is important for subjects with a history of falls and/or being at risk of falls. TRIAL REGISTRATION ClinicalTrials.gov NCT03462654 . Registered on March 12, 2018.
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Evaluating Accelerometry Thresholds for Detecting Changes in Levels of Moderate Physical Activity and Resulting Major Mobility Disability.
Rejeski, WJ, Walkup, MP, Fielding, RA, King, AC, Manini, T, Marsh, AP, McDermott, M, Miller, EY, Newman, AB, Tudor-Locke, C, et al
The journals of gerontology. Series A, Biological sciences and medical sciences. 2018;(5):660-667
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BACKGROUND An important decision with accelerometry is the threshold in counts per minute (CPM) used to define moderate to vigorous physical activity (MVPA). We explore the ability of different thresholds to track changes in MVPA due to a physical activity (PA) intervention among older adults with compromised function: 760 CPM, 1,041 CPM, and an individualized threshold. We also evaluate the ability of change in accelerometry and self-reported PA to attenuate treatment effects on major mobility disability (MMD). METHODS Data from a week of hip worn accelerometers and self-reported PA data (30-day recall) were examined from baseline, 6-, 12-, and 24-months of follow-up on 1,528 older adults. Participants were randomized to either PA or Health Education (HE). MMD was objectively defined by loss of ability to walk 400 m during the follow-up. RESULTS The three thresholds yielded similar and higher levels of MVPA for PA than HE (p < .001), however, this difference was significantly attenuated in participants with lower levels of physical function. Self-reported PA that captured both walking and strength training totally attenuated the intervention effect for MMD, an 18% reduction to a 3% increase. Accelerometer CPMs showed less attenuation of the intervention effect. CONCLUSIONS Accelerometry assessment within the LIFE study was not sensitive to change in level in physical activity for older adults with very low levels of physical function. A combination of self-report and objective measures are recommended for use in physical activity intervention studies of the elderly; limitations of accelerometry deserve closer attention.
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Objectively Measured Physical Activity in European Adults: Cross-Sectional Findings from the Food4Me Study.
Marsaux, CF, Celis-Morales, C, Hoonhout, J, Claassen, A, Goris, A, Forster, H, Fallaize, R, Macready, AL, Navas-Carretero, S, Kolossa, S, et al
PloS one. 2016;(3):e0150902
Abstract
BACKGROUND Comparisons of objectively measured physical activity (PA) between residents of European countries measured concurrently with the same protocol are lacking. We aimed to compare PA between the seven European countries involved in the Food4Me Study, using accelerometer data collected remotely via the Internet. METHODS Of the 1607 participants recruited, 1287 (539 men and 748 women) provided at least 3 weekdays and 2 weekend days of valid accelerometer data (TracmorD) at baseline and were included in the present analyses. RESULTS Men were significantly more active than women (physical activity level = 1.74 vs. 1.70, p < 0.001). Time spent in light PA and moderate PA differed significantly between countries but only for women. Adherence to the World Health Organization recommendation to accumulate at least 150 min of moderate-equivalent PA weekly was similar between countries for men (range: 54-65%) but differed significantly between countries for women (range: 26-49%). Prevalence estimates decreased substantially for men and women in all seven countries when PA guidelines were defined as achieving 30 min of moderate and vigorous PA per day. CONCLUSIONS We were able to obtain valid accelerometer data in real time via the Internet from 80% of participants. Although our estimates are higher compared with data from Sweden, Norway, Portugal and the US, there is room for improvement in PA for all countries involved in the Food4Me Study.
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Prenatal Hemoglobin Levels and Early Cognitive and Motor Functions of One-Year-Old Children.
Mireku, MO, Davidson, LL, Koura, GK, Ouédraogo, S, Boivin, MJ, Xiong, X, Accrombessi, MM, Massougbodji, A, Cot, M, Bodeau-Livinec, F
Pediatrics. 2015;(1):e76-83
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OBJECTIVE To explore the relationship between prenatal hemoglobin (Hb) concentration and infant cognitive and motor functions. METHODS Our prospective cohort study included 1-year-old children born to women enrolled at their first antenatal care (ANC) visit in Allada, Benin, before 29 weeks of pregnancy, within a trial comparing the efficacy of sulfadoxine-pyrimethamine and mefloquine. Hb concentrations of pregnant women were determined from venous blood samples collected at first and second ANC visits of at least 1-month interval and at delivery. Women were prescribed oral iron, folic acid, and anthelminthics after the first ANC visit. A total of 636 children (76.8% of eligible children) were assessed by trained research nurses for cognitive and motor functions by using the Mullen Scales of Early Learning. RESULTS Prevalence of anemia (Hb < 110 g/L) decreased from 67.0% at first ANC visit (mean gestational age [SD], 22.1 [4.0] weeks) to 38.4% at delivery. Mean (SD) Hb concentrations increased from 103.7 (12.3) at first ANC visit to 112.4 (14.1) at delivery. We observed a significant negative quadratic relationship between infant gross motor (GM) function and Hb concentration at first and second ANC visits. Thus, infant GM scores increased sharply with increasing maternal Hb concentration until 90 g/L where increasing GM was mild, and began to decline after 110 g/L. CONCLUSIONS There appears to be an Hb concentration range that may be optimal for GM function of 1-year-old children. This may reflect the importance of physiologic hemodilution, which occurs after the second trimester until 34 weeks of gestation.
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Functional Impairments Mediate Association Between Clinical Fracture Risk and Type 2 Diabetes Mellitus in Older Women.
Lee, RH, Pieper, CF, Colón-Emeric, C
Journal of the American Geriatrics Society. 2015;(8):1546-51
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OBJECTIVES To examine the effect of functional impairments in older women with diabetes mellitus (DM) on incident clinical fractures. DESIGN Secondary analysis of two large prospective cohort studies. SETTING North Carolina Established Populations for Epidemiologic Studies of the Elderly (EPESE) and Women's Health Initiative (WHI) clinical trials. PARTICIPANTS EPESE included 2,704 community-dwelling women aged 65 and older; WHI clinical trials included 68,125 postmenopausal women. MEASUREMENTS Women with DM at baseline were compared with women without in successive Cox proportional hazards models. Functional limitations were determined according to self-reported difficulties with activities of daily living (ADLs) and physical activities. RESULTS The risk of any clinical fracture during the study period was greater in women with DM, after controlling for age, race and ethnicity, and body mass index, in the EPESE (hazard ratio (HR) = 1.36, 95% confidence interval (CI) = 1.08-1.72) and WHI (HR = 1.29, 95% CI = 1.19-1.39) cohorts. After inclusion of functional limitations, the greater risk of fracture associated with DM decreased in the EPESE (HR = 1.25, 95% CI = 0.98-1.59) and WHI (HR = 1.21, 95% CI = 1.12-1.31) cohorts. In participants with DM, difficulties with moderate physical activities, such as bending or stooping, walking several blocks, and heavy housework, were significantly associated with incident fracture (P < .05). CONCLUSION Older women with DM are at greater risk of clinical fractures than those without, independent of bone mineral density. Greater functional impairment in moderate physical activities mediates this greater fracture risk in part, although there remains an unexplained residual DM-associated risk for fracture.
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Aging and physical function in type 2 diabetes: 8 years of an intensive lifestyle intervention.
Rejeski, WJ, Bray, GA, Chen, SH, Clark, JM, Evans, M, Hill, JO, Jakicic, JM, Johnson, KC, Neiberg, R, Ip, EH, et al
The journals of gerontology. Series A, Biological sciences and medical sciences. 2015;(3):345-53
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BACKGROUND Compared with adults without type 2 diabetes mellitus, those with the disease experience more limitations in their physical functioning (PF). Look AHEAD is a large multicenter trial that examined the effects of an intensive lifestyle intervention (ILI) for weight loss on cardiovascular outcomes compared with diabetes support and education (DSE). Although the current study compared treatment differences between ILI and DSE on PF, the primary goal was to examine whether this effect was moderated by age and history of cardiovascular disease at enrollment. METHODS Overweight or obese adults with type 2 diabetes mellitus (n = 5,145) were randomly assigned to either ILI or DSE. The mean (±SD) age and % females in ILI was 58.9 years (±6.9) and 59.8%; it was 58.6 years (6.8) and 59.5% in DSE. Analysis in 4,998 participants assessed the differential rates of decline in PF across a period of 8 years for the ILI and DSE groups. RESULTS ILI resulted in improved PF compared with DSE after 1 year (p < .0001) and was maintained across time. Within the ILI, older adults experienced greater improvements than younger adults (p < .0001). By year 2, persons in ILI with preexisting cardiovascular disease were no different in PF than in DSE participants with preexisting cardiovascular disease. CONCLUSION With the exception of persons who had a history of cardiovascular disease, ILI slowed the decline in PF with type 2 diabetes mellitus despite weight regain, an effect that was stronger for older than younger participants and could translate into reductions in falls and disability.
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Social and Environmental Factors Related to Boys' and Girls' Park-Based Physical Activity.
Bocarro, JN, Floyd, MF, Smith, WR, Edwards, MB, Schultz, CL, Baran, P, Moore, RA, Cosco, N, Suau, LJ
Preventing chronic disease. 2015;:E97
Abstract
INTRODUCTION Parks provide opportunities for physical activity for children. This study examined sex differences in correlates of park-based physical activity because differences may indicate that a standard environmental intervention to increase activity among children may not equally benefit boys and girls. METHODS The System for Observation Play and Recreation in Communities was used to measure physical activity among 2,712 children and adolescents in 20 neighborhood parks in Durham, North Carolina, in 2007. Sedentary activity, walking, vigorous park activity, and energy expenditure were the primary outcome variables. Hierarchical logit regression models of physical activity were estimated separately for boys and girls. RESULTS Type of activity area and presence of other active children were positively associated with boys' and girls' physical activity, and presence of a parent was negatively associated. A significant interaction involving number of recreation facilities in combination with formal activities was positively associated with girls' activity. A significant interaction involving formal park activity and young boys (aged 0-5 y) was negatively associated with park-based physical activity. CONCLUSION Activity area and social correlates of park-based physical activity were similar for boys and girls; findings for formal park programming, age, and number of facilities were mixed. Results show that girls' physical activity was more strongly affected by social effects (eg, presence of other active children) whereas boys' physical activity was more strongly influenced by the availability of park facilities. These results can inform park planning and design. Additional studies are necessary to clarify sex differences in correlates of park-based physical activity.
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The longitudinal effects of physical activity and dietary calcium on bone mass accrual across stages of pubertal development.
Lappe, JM, Watson, P, Gilsanz, V, Hangartner, T, Kalkwarf, HJ, Oberfield, S, Shepherd, J, Winer, KK, Zemel, B
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2015;(1):156-64
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Childhood and adolescence are critical periods of bone mineral content (BMC) accrual that may have long-term consequences for osteoporosis in adulthood. Adequate dietary calcium intake and weight-bearing physical activity are important for maximizing BMC accrual. However, the relative effects of physical activity and dietary calcium on BMC accrual throughout the continuum of pubertal development in childhood remains unclear. The purpose of this study was to determine the effects of self-reported dietary calcium intake and weight-bearing physical activity on bone mass accrual across the five stages of pubertal development in a large, diverse cohort of US children and adolescents. The Bone Mineral Density in Childhood study was a mixed longitudinal study with 7393 observations on 1743 subjects. Annually, we measured BMC by dual-energy X-ray absorptiometry (DXA), physical activity and calcium intake by questionnaire, and pubertal development (Tanner stage) by examination for up to 7 years. Mixed-effects regression models were used to assess physical activity and calcium intake effects on BMC accrual at each Tanner stage. We found that self-reported weight-bearing physical activity contributed to significantly greater BMC accrual in both sexes and racial subgroups (black and nonblack). In nonblack males, the magnitude of the activity effect on total body BMC accrual varied among Tanner stages after adjustment for calcium intake; the greatest difference between high- and low-activity boys was in Tanner stage 3. Calcium intake had a significant effect on bone accrual only in nonblack girls. This effect was not significantly different among Tanner stages. Our findings do not support differential effects of physical activity or calcium intake on bone mass accrual according to maturational stage. The study demonstrated significant longitudinal effects of weight-bearing physical activity on bone mass accrual through all stages of pubertal development.