Repeated Measures Analysis Of Covariance Research Articles

Musculoskeletal changes after 1 year of exercise in older breast cancer survivors

We have previously reported that 1year of supervised resistance + impact training stopped bone loss and built muscle strength in older breast cancer survivors. The purpose of this study was to determine whether these benefits persisted 1year after completion of the intervention. Sixty-seven women from the original trial completed baseline and post-intervention body composition and muscle strength tests, and 44 women were available 1year later for follow-up assessments. Bone mineral density (grams per square centimeter) of the hip and spine, muscle mass (kilograms), and fat mass (kilograms) were measured by dual-energy X-ray absorptiometry and maximal upper and lower body strength were measured by one-repetition maximum tests (kilograms). We compared between group changes across baseline (pre-intervention), 1 (post-intervention), and 2years (1year follow up) on study outcomes using repeated-measures analysis of covariance, adjusting for age. Significant group by time interactions were found for spine bone mineral density (BMD) (p < 0.01) and lower body muscle strength (p < 0.05), with a trend for upper body muscle strength (p = 0.05). Spine BMD remained stable across intervention and follow-up periods in exercisers compared with continuous losses in controls across 1- and 2-year periods. In contrast, lower body strength increased in exercisers across the intervention, but decreased to near-baseline levels during follow-up compared with no change over either time period in controls. Our data suggest that spine BMD can be preserved in older breast cancer survivors even after formal exercise training stops; however, muscle strength is not similarly maintained and may require continued participation in a supervised exercise program. Exercise programs aimed at improving musculoskeletal health should be considered in the long-term care plan for breast cancer survivors.

Are There Differences in Neurocognitive Function and Symptoms Between Male and Female Soccer Players After Concussions?

Background: Researchers have suggested that there are sex differences in outcomes after sport-related concussions. Factors such as sport type/rules, age, and body mass index (BMI) may influence these differences. Hypotheses/Purpose: The purposes of this study were (1) to examine neurocognitive performance after concussions between male and female soccer players and (2) to compare concussion symptoms between male and female soccer players. We hypothesized that female concussed soccer players would report more concussion symptoms and worse cognitive performance compared with male concussed soccer players. Study Design: Cohort study; Level of evidence, 2. Methods: A total of 39 male (mean BMI, 22.21 ± 2.34 kg/m2; mean age, 17.69 ± 2.10 years) and 56 female (mean BMI, 23.47 ± 2.66 kg/m2; mean age, 17.78 ± 2.30 years) concussed soccer players participated in this study. Participants were similar in age, history of concussion, sport, and time since injury. Participants completed computerized neurocognitive tests and symptom reports at baseline and 8 days after injury. Body mass index served as a covariate in all analyses. Results: After adjusting for BMI, results from a repeated-measures analysis of covariance (ANCOVA) revealed a group by time interaction for visual memory (F1,82 = 5.50; P = .021). Specifically, female concussed soccer players (mean score, 68.7 ± 15.2) performed worse at 8 days after a concussion compared with male concussed athletes (mean score, 77.2 ± 8.9). Results of another ANCOVA for total concussion symptoms indicated an interaction for group by time (F1,82 = 4.26; P = .04). Specifically, female concussed soccer players (mean score, 11.9 ± 15.7) reported more total concussion symptoms at 8 days compared with male concussed athletes (mean score, 5.3 ± 7.4). There were significant main effects for sex on verbal (F1,82 = 5.98; P = .017) and visual (F1,82 = 4.65; P = .034) memory, with female athletes reporting lower scores than male athletes. Female athletes also reported more symptoms on the migraine-cognitive-fatigue (F1,82 = 10.8; P = .001) and sleep (F1,82 = 9.2; P = .003) clusters than male athletes. Conclusion: In contrast to recent studies, after controlling for BMI, female athletes exhibited lower performance on visual memory composite scores and higher scores on total symptoms than male athletes after concussions.

Bone mineral changes after lactation in Gambian women accustomed to a low calcium intake.

BACKGROUND/OBJECTIVES:Previous studies in Gambian women with a low calcium intake have described decreases in whole-body and regional bone mineral content (BMC) and areal bone mineral density (aBMD) during the first year of lactation. The aim of this study was to examine whether these effects are reversed after lactation.SUBJECTS/METHODS:Thirty-three Gambian women who had a previous dual-energy X-ray absorptiometry (DXA) scan at 52 weeks lactation (L52) were invited to participate in a follow-up study when neither pregnant nor lactating (NPNL) for ⩾3 months and/or when 52 weeks postpartum in a subsequent lactation (F52). Whole body, lumbar spine and hip bone mineral were measured by DXA. Anthropometry and dietary assessments were also conducted. Repeated-measures analysis of covariance was used to determine differences from L52 at NPNL and F52.RESULTS:Twenty-eight women were scanned at NPNL and 20 at F52. The mean±s.d. calcium intake of the 33 women at NPNL and F52 was 360±168 mg/day. BMC, aBMD and size-adjusted BMC (SA-BMC) at all sites were higher at NPNL than L52. Percent increases in SA-BMC (mean±s.e.m.) were significant (P<0.0001): whole body=2.7±0.4% lumbar spine=4.9±1.0% total hip=3.7±1.0%. There were no significant differences in any measurements between the two lactation time points (L52 and F52).CONCLUSIONS:This study of Gambian women with low calcium intakes demonstrates that bone mineral mobilised during lactation is recovered after lactation. Successive periods of long lactation are not associated with progressive skeletal depletion.

Urocortin-2 Infusion in Acute Decompensated Heart Failure: Findings From the UNICORN Study (Urocortin-2 in the Treatment of Acute Heart Failure as an Adjunct Over Conventional Therapy)

The purpose of this study is to investigate the effects of urocortin-2 as adjunct therapy in acute decompensated heart failure (ADHF). Urocortin-2 produced favorable integrated effects in experimental heart failure but there are no equivalent human data. We describe the first therapeutic study of urocortin-2 infusion in ADHF. Fifty-three patients with ADHF were randomly assigned to 5 ng/kg/min of urocortin-2 or placebo infusion for 4 h as an adjunct therapy. Changes in vital signs, plasma neurohormonal and renal indices during treatment were compared using repeated-measures analysis of covariance. Ten patients in each arm underwent more detailed invasive hemodynamic evaluation. Urocortin-2 produced greater falls in systolic blood pressure compared to placebo (16 ± 5.8 mm Hg, p < 0.001) with nonsignificant increases in heart rate (5.7 ± 3.8 beats/min, p = 0.07) and increased cardiac output (2.1 ± 0.4 l/min vs. -0.1 ± 0.4 l/min, p < 0.001) associated with a 47% reduction in calculated total peripheral resistance (p = 0.015). Falls in pulmonary artery and pulmonary capillary wedge pressures did not differ significantly between groups. Urocortin-2 reduced urine volume and creatinine clearance during infusion but these returned to above baseline level in the 8 h after infusion. Plasma renin activity rose briefly with urocortin-2 coinciding with reductions in blood pressure (p < 0.001). B-type natriuretic peptide levels fell significantly over 24 h with urocortin-2 (p < 0.01) but not with placebo. Urocortin-2 infusion in ADHF markedly augmented cardiac output without significant reflex tachycardia. Renal indices fell transiently concurrent with urocortin-2-induced reductions in blood pressure. Further investigations are required to uncover the full potential of urocortin-2 in treating ADHF.

Concussion Symptoms and Neurocognitive Performance of High School and College Athletes Who Incur Multiple Concussions

Background: Multiple concussions have been associated with prolonged symptoms, recovery time, and risk for future concussions. However, very few studies have examined the effect of multiple concussions on neurocognitive performance and the recently revised symptom clusters using a large database. Purpose: To examine concussed athletes with a history of 0, 1, 2, or ≥3 concussions on neurocognitive performance and the recently revised symptom clusters. Study Design: Cohort study (prognosis); Level of evidence, 2. Methods: The independent variables were concussion group (0, 1, 2, and ≥3 concussions) and time (baseline, 3 days, and 8 days). The dependent variables were neurocognitive test scores as measured by the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) neurocognitive test battery (verbal and visual memory, processing speed, and reaction time) and 4 concussion symptom clusters (migraine-cognitive-fatigue, affective, somatic, and sleep). All concussed athletes (n = 596) were administered the ImPACT test at a mean 2.67 ± 1.98 and 7.95 ± 4.46 days after injury. A series of 4 (concussion group) × 3 (time) repeated-measures analyses of covariance (age = covariate) were performed on ImPACT composite scores and symptom clusters. Results: Concussed athletes with ≥3 concussions were still impaired 8 days after a concussion compared with baseline scores on verbal memory (P < .001), reaction time (P < .001), and migraine-cognitive-fatigue symptoms (P < .001). There were no significant findings on the remaining dependent variables. Conclusion: Concussed athletes with a history of ≥3 concussions take longer to recover than athletes with 1 or no previous concussion. Future research should concentrate on validating the new symptom clusters on multiple concussed athletes, examining longer recovery times (ie, >8 days) among athletes with multiple concussions.

Long-term benefits of radon spa therapy in rheumatic diseases: results of the randomised, multi-centre IMuRa trial

In chronic rheumatic diseases, recent treatment regimens comprise multimodal concepts including pharmacologic, physical/exercise, occupational and psychological therapies. Rehabilitation programmes are used for long-term management of disease. Spa therapy is often integrated in various middle and south European and Asian countries. Here, we investigated radon spa therapy as applied in health resorts compared to a control intervention in rheumatic out-patients. Randomised, blinded trial enroling 681 patients [mean age 58.3 (standard deviation 11.1); female 59.7%] in 7 health resorts in Germany and Austria with chronic back pain (n 1 = 437), osteoarthritis (OA) (n 2 = 230), rheumatoid arthritis (n 3 = 98), and/or ankylosing spondylitis (n 4 = 39); multiple nominations in 146 cases). Outcomes were pain (primary), quality of life, functional capacity, and medication measured before start, after end of treatment, and 3 times thereafter in 3 monthly intervals. Adverse events were documented. To analyse between-group differences, repeated-measures analysis of covariance was performed in metric endpoints and Fisher's exact test in rates. Two-sided significance level of 5% was chosen. Until end of follow-up, superiority of radon therapy was found regarding pain relief (p = 0.032) and analgesic drug consumption (p = 0.007), but not regarding quality of life. Functional capacity was assessed specific to the underlying indication. Significant benefits were found in radon-treated OA patients until 6-month follow-up (p = 0.05), but not until end of study (p = 0.096). Neither the back pain sub-population nor the two smaller patient populations with inflammatory indications benefited significantly in functional capacity. Results suggest beneficial analgesic effects of radon spa therapy in rheumatic diseases until 9 months post-intervention.

Effect of a Cognitive Behavioral Self‐Help Intervention on Depression, Anxiety, and Coping Self‐Efficacy in People With Rheumatic Disease

The aim of this study was to investigate whether a new cognitive-behavioral self-help program with minimal coaching could improve psychological well-being (depression, anxiety, and coping self-efficacy) in people with rheumatic disease and depressive symptoms. In total, 82 persons with a rheumatic disease enrolled in a randomized controlled trial were allocated to either a group receiving the self-help program or a waiting list control condition group. For both groups, measurements were done at baseline, posttest, and followup. The outcome measures were the depression and anxiety scales of the Hospital Anxiety and Depression Scale and an adaptation of the Generalized Self-Efficacy Scale. Repeated-measures analyses of covariance were performed to evaluate changes in outcome measures from pretest to posttest and from posttest to followup. The results showed that the self-help program was effective in reducing symptoms of depression and anxiety and in strengthening coping self-efficacy. The positive effects remained after a followup period of 2 months. This cost-effective program could very well be used as a first step in a stepped care approach or as one of the treatment possibilities in a matched care approach.

Depression Impacts the Course of Recovery in Patients with Acute Low-Back Pain

Little is known about the course of recovery of acute low back pain (LBP) patients as a function of depression. In a prospective study, 286 acute LBP patients were assessed at baseline and followed up over 6 months. Recovery was defined as improvement in the Oswestry Disability Index (ODI). Repeated-measures analysis of covariance was employed with ODI as repeated factor, age, sex, and body mass index as covariates, depression and all other potential prognostic factors as between-subject factors. Of study participants, 18% were classified as depressive (>33 points on the Zung Self-Rating Depression Scale). Of 286 participants, 135 were lost to follow-up. In the longitudinal sample of 151 patients the course of recovery was slower in depressive patients. Depression was associated with LBP especially after 6 weeks and should therefore be included in screening instruments for acute LBP patients to identify those at risk of delayed recovery at an early stage.

A Year-long Caregiver Training Program to Improve Neurocognition in Preschool Ugandan HIV-exposed Children

Mediational intervention for sensitizing caregivers (MISC) is a structured program enabling caregivers to enhance their child's cognitive and emotional development through daily interactions. The principal aim was to evaluate if a year-long MISC caregiver training program produced greater improvement in child cognitive and emotional development compared with a control program. One hundred and nineteen uninfected HIV-exposed preschool children and their caregivers were randomly assigned to 1 of 2 treatment arms: biweekly MISC training alternating between home and clinic for 1 year or a health and nutrition curriculum. All children were evaluated at baseline, 6 months, and 1 year with the Mullen Early Learning Scales, Color-Object Association Test for memory, and Achenbach Child Behavior Checklist for psychiatric symptoms. Caregivers were evaluated on the same schedule with the Hopkins Symptoms Checklist-25 for depression and anxiety. The treatment arms were compared using repeated-measures analysis of covariance with child age, gender, weight, socioeconomic status, caregiving quality, caregiver anxiety, and caregiver education as covariates. The MISC children had significantly greater gains compared to controls on the Mullen Receptive and Expressive Language development, and on the Mullen composite score of cognitive ability. Color-Object Association Test total memory for MISC children was marginally better than controls. No Achenbach Child Behavior Checklist differences between the groups were noted. Caldwell Home Observation for Measurement of the Environment scores and observed mediational interaction scores from videotapes measuring caregiving quality also improved significantly more for the MISC group. The MISC enhanced cognitive performance, especially in language development. These benefits were possibly mediated by improved caregiving and positive emotional benefit to the caregiver.

Does knee external rotation differ according to frontal plane knee alignment and the presence of patellofemoral osteoarthritis after anterior cruciate ligament reconstruction?

Does knee external rotation differ according to frontal plane knee alignment and the presence of patellofemoral osteoarthritis after anterior cruciate ligament reconstruction?

Regression analysis of growth responses to water depth in three wetland plant species.

Plant species composition in wetlands and on lakeshores often shows dramatic zonation, which is frequently ascribed to differences in flooding tolerance. This study compared the growth responses to water depth of three species (Phormium tenax, Carex secta and Typha orientalis) differing in depth preferences in wetlands, using non-linear and quantile regression analyses to establish how flooding tolerance can explain field zonation. Plants were established for 8 months in outdoor cultures in waterlogged soil without standing water, and then randomly allocated to water depths from 0 to 0.5 m. Morphological and growth responses to depth were followed for 54 days before harvest, and then analysed by repeated-measures analysis of covariance, and non-linear and quantile regression analysis (QRA), to compare flooding tolerances. Growth responses to depth differed between the three species, and were non-linear. Phormium tenax growth decreased rapidly in standing water >0.25 m depth, C. secta growth increased initially with depth but then decreased at depths >0.30 m, accompanied by increased shoot height and decreased shoot density, and T. orientalis was unaffected by the 0- to 0.50-m depth range. In P. tenax the decrease in growth was associated with a decrease in the number of leaves produced per ramet and in C. secta the effect of water depth was greatest for the tallest shoots. Allocation patterns were unaffected by depth. The responses are consistent with the principle that zonation in the field is primarily structured by competition in shallow water and by physiological flooding tolerance in deep water. Regression analyses, especially QRA, proved to be powerful tools in distinguishing genuine phenotypic responses to water depth from non-phenotypic variation due to size and developmental differences.

Professional baseball athletic trainers' perceptions of preparation for job-specific duties.

The extent to which individuals are prepared completely for work in a particular athletic training setting (eg, professional sports, college, high school) is unknown. This issue is critical today, and findings in this area have implications for athletic training education policy and employers. To determine the perceptions of preparation for work-specific tasks by professional baseball athletic trainers (PBATs). We also wanted to determine whether various preparation experiences interact with perceived skills. Cross-sectional study. Online survey administered via Survey-Monkey. Two hundred seventy-five PBATs. The PBATs reported their levels of preparation before employment in their positions and their current skills in each of the 8 work task domains: evaluation of elbow injuries; evaluation of shoulder injuries; evaluation of general injuries; acute care; injury prevention; treatment, rehabilitation, and reconditioning; organization and administration; and non-athletic-training tasks. Nine repeated-measures analyses of covariance were performed with each perception of preparation (retrospective, current) as a within-subject factor. Preparation experiences were included as between-subjects factors, and number of years working in baseball was the covariate. Subscale reliabilities were calculated and found to be between 0.79 and 0.97. A total of 180 PBATs (65%) completed the survey. The backgrounds and routes by which PBATs gained employment in the professional baseball setting varied. Individuals who completed professional baseball internships, had previous work experience, and immediately entered the professional baseball setting after graduation had noted differences in their perceptions of preparation for work tasks. The PBATs indicated they were substantially underprepared for tasks in the organization and administration and non-athletic-training task domains. The organizational socialization process is complex, and no 1 experience appears to completely prepare an individual for work in the professional baseball setting.

A randomised clinical trial (RCT) of a symbiotic mixture in patients with irritable bowel syndrome (IBS): effects on symptoms, colonic transit and quality of life

PurposeThe aim of this study is to test in a double-blinded, randomised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms, colonic transit and quality of life in irritable bowel syndrome (IBS) patients who meet Rome III criteria.BackgroundThere is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS.MethodsThis is a double-blinded, randomised placebo-controlled study of a symbiotic mixture (Probinul, 5 g bid) over 4 weeks after 2 weeks of run-in. The primary endpoints were global satisfactory relief of abdominal flatulence and bloating. Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief. The secondary endpoints were change in abdominal bloating, flatulence, pain and urgency by a 100-mm visual analog scale, stool frequency and bowel functions on validated adjectival scales (Bristol Scale and sense of incomplete evacuation). Pre- and post-treatment colonic transit time (Metcalf) and quality of life (SF-36) were assessed.ResultsSixty-four IBS patients (symbiotic n = 32, 64 % females, mean age 38.7 ± 12.6 years) were studied. This symbiotic mixture reduced flatulence over a 4-week period of treatment (repeated-measures analysis of covariance, p < 0.05). Proportions of responders were not significantly different between groups. At the end of the treatment, a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group.ConclusionsThis symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients, a lack of adverse events and a good side-effect profile; however, it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating. Further studies are warranted.

Changes in passive range of motion and development of glenohumeral internal rotation deficit (GIRD) in the professional pitching shoulder between spring training in two consecutive years

Pitching causes increased mechanical stress to the arm and is thought to result in alterations in range of motion (ROM) as a result of osseous and soft tissue adaptations. Understanding the factors that contribute to alterations in ROM will allow for improved understanding of the pitching shoulder. This study examined humeral torsion (HT) and shoulder mobility over 2 consecutive years. Bilateral shoulder mobility and HT were assessed in 33 asymptomatic professional pitchers over 2 spring trainings. A repeated-measures analysis of covariance was used to assess the change in motion of the dominant side/nondominant side across seasons while quantifying pre-existing HT. Prevalence of glenohumeral internal rotation deficit (GIRD) between seasons was compared with χ(2) analysis, and GIRD and non-GIRD pitchers were compared with the independent t test. The dominant shoulder displayed increased external rotation (11.5° ± 0.1°, P = .02) and decreased internal rotation (-8.4° ± 11.0°, P = .03) and horizontal adduction (-17.6° ± 13.8°, P = .01). The nondominant shoulder remained the same. Mean HT was significantly different (P = .001) in the dominant (10° ± 11°) arm than in the nondominant arm (23° ± 11°). A significant number of pitchers had with GIRD (P < .01) at each assessment. ROM was significantly altered between seasons of pitching. These changes likely resulted from soft tissue adaptations because we accounted for humeral retrotorsion. Pitchers who developed GIRD displayed a 7° increase in retrotorsion on the dominant shoulder. Changes in the pitching shoulder over time accounting for humeral retrotorsion may suggest pitching ROM is transient and should be monitored.

Course of Recovery in Patients with Acute Low Back Pain: Does Depression Matter?

Introduction While there is extensive knowledge on the course of acute low back pain (LBP), little is known about the course of recovery of acute LBP patients as a function of depression. The aims of our study were to determine if the course of recovery in patients with acute LBP differs in relation to the presence/absence of depression and to identify the best time point for an intervention against LBP-associated depression. Materials and Methods This is a prospective cohort study of 286 patients with acute LBP. Patients were assessed at baseline and followed up over 6 months addressing psychological, occupational, biomedical, and demographic/lifestyle factors. Recovery was defined as improvement in functional limitation measured by the Oswestry disability index (ODI); depression was defined by the Zung depression scale. Repeated-measures analysis of covariance (ANCOVA) was employed with ODI as repeated factor, age, gender, and body mass index as covariates, depression and all other potential prognostic factors as between-subject factors. A second ANCOVA was performed with depression as dependent variable and functional limitation, pain intensity, and job stressors as potential predictor variables. Results A total of 18% of study participants were classified as depressive. In these patients, the course of recovery was slower than in nondepressive patients. ODI scores in the nondepression-LBP group decreased over time, whereas scores in the depression-LBP group remained at the same level (F(3.295, 431.607) = 4.63; p &lt; 0.01, partial η2 = 0.034; Fig. 1). High functional limitation (F(1.261) = 15.79; p &lt; 0.001, partial η2 = 0.057), high pain intensity (F(1.260) = 6.84; p &lt; 0.01, partial η2 = 0.026), and a high job stressor index (F(1.252) = 8.95; p &lt; 0.01, partial η2 = 0.034) were predictors of depression at baseline. Further, the presence of depression caused maintenance of LBP especially after 6 weeks. Conclusion The presence of depression has a negative influence on the course of recovery in patients presenting with a new episode of LBP. Therefore, depression should be included in screening instruments for patients with acute LBP to identify those at risk of delayed recovery at an early stage. Further research is required investigating interventions at different time points, to identify the optimal time at which to treat acute LBP patients with concomitant depression to reduce the socioeconomic costs of delayed recovery. I confirm having declared any potential conflict of interest for all authors listed on this abstract Yes Disclosure of Interest None declared

Outcomes from a Medical Weight Loss Program: Primary Care Clinics Versus Weight Loss Clinics

BackgroundFew studies have focused on weight loss programs implemented in community-based primary care settings. The objective of this analysis was to evaluate the effectiveness of a weight loss program and determine whether physicians in primary care practices could achieve reductions in body weight and body fat similar to those obtained in weight loss clinics. MethodsAnalyses were performed on chart review data from 413 obese participants who underwent weight loss at a primary care (n=234) or weight loss (n=179) clinic. Participants received physician-guided behavioral modification sessions and self-selected a diet plan partially or fully supplemented by meal replacements. A repeated-measures analysis of covariance was conducted with age and sex serving as covariates; significance was set at P≤.05. ResultsIn 178 subjects (43%) completing 12 weeks of the program, primary care clinics were as effective as weight loss clinics at achieving reductions in body weight (12.4 vs 12.1 kg) but better with regard to reduction in body fat percentage (3.8% vs 2.7%; P≤.05). Regardless of location, participants completing 12 weeks lost an average of 11.1% of their body weight. Participants selecting full meal replacement had greater reductions in weight and body fat percentage (12.7 kg, 3.5%) compared with participants selecting a partial meal replacement plan (8.3 kg, 2.3%). ConclusionPrimary care physicians can successfully manage and treat obese patients using behavioral modification techniques coupled with meal replacement diets.

Short-Term Effects of 890-Nanometer Radiation on Pain, Physical Activity, and Postural Stability in Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Study

Hsieh R-L, Lo M-T, Liao W-C, Lee W-C. Short-term effects of 890-nanometer radiation on pain, physical activity, and postural stability in patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study. ObjectiveTo investigate the effects of short-term light therapy with 890-nm radiation on pain, physical activity, and postural stability in patients with knee osteoarthritis (OA). DesignA double-blind, randomized, placebo-controlled study. SettingRehabilitation clinic. ParticipantsWomen (n=62) and men (n=10) with a mean age of 61.2 years (range, 40–88y). All patients fulfilled the combined clinical and radiographic criteria for knee OA as established by the American College of Rheumatology, and all had obtained a Kellgren-Lawrence score of 2 or more. InterventionsParticipants received 6 sessions, lasting 40 minutes each, of active or placebo radiation treatment over the knee joints for 2 weeks (wavelength, 890nm; radiant power output, 6.24W; power density, 34.7mW/cm2 for 40 minutes; total energy, 41.6J/cm2 per knee per session). Main Outcome MeasuresParticipants were assessed weekly over 4 weeks using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain, stiffness, and physical function. Physical activity (timed stair climbing, 10-m fast-speed walking, and chair-rising time) and postural stability (using the postural stability evaluation system) were also assessed. The pain score on WOMAC was the primary outcome variable. Data were analyzed by repeated-measures analysis of covariance. ResultsCompared with baseline, no significant improvement was observed between groups for pain (P=.546), stiffness (P=.573), or physical function (P=.904). No significant improvement was noted for physical activity including the 10-m fast-speed walking time (P=.284), stair-climbing time (P=.202), stair-descending time (P=.468), chair-rising time (P=.499), or postural stability (P=.986) at the 4 follow-up assessments. Follow-up assessments were conducted after 1 week of treatment (thus, after 3 treatments); after 2 weeks of treatment (thus, after 6 treatments); and 1 and 2 weeks, respectively, after treatment was terminated. Although we found a significant time effect for the 10-m fast-speed walking time (P<.001) in the 2 groups, and a significant group effect in the improvement of stair-climbing time in the treatment group (P=.032), the group × time interaction effects were not significant. ConclusionsShort-term 890-nm radiation therapy for patients with knee OA provided no beneficial effect in improving pain, physical activity, and postural stability.

AOS14 Phase II clinical study of combination chemotherapy with herb Withania somnifera (ashwagandha) in breast cancer

Background Herbal drugs are generally avoided during systemic chemotherapy because of herb–drug interaction and exaggeration of chemotherapy-related toxicity. We used a common medicinal herb Withania somnifera (ashwagandha) in addition to systemic chemotherapy in patients with breast cancer. This herb is haemoprotective, enhances cytotoxicity of chemotherapy, has radiosensitive properties, and improves the general wellbeing of patients. Methods This was a prospective non-randomised clinical trial comparing the outcomes of W. somnifera plus chemotherapy with chemotherapy alone (control) in women with breast cancer. Fifty patients with all stages of breast cancer that required systemic chemotherapy were alternatively assigned to study drug or no further treatment using defined selection criteria. W. somnifera root extract in vegetarian capsule form was given at an oral dose of 2 g tds during six courses of chemotherapy to the patients in the combination group. Piper’s fatigue score (PFS), Schwartz’s cancer fatigue score (SCFS), European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C-30 (version 3) at the beginning (1st cycle), during, and after chemotherapy (6th cycle), clinical parameters, and response to therapy in both groups were monitored. The haematological parameters were monitored during the six cycles of chemotherapy. Correlation of the quality of life (QoL) and fatigue over time as numerical covariates was evaluated using the repeated-measure analysis of covariance (ANCOVA) method, and survival analysis was done with Kaplan–Meier non-parametric estimation using SPSS (version 18, IBM) software. Findings Fifty patients were recruited to each group, with a median age of 51 years (range 36–70 years) in the W. somnifera plus chemotherapy group and 50.5 years (range 30–82 years) in the control group. Eight patients had stage I, 33 stage II, 44 stage III, and 15 stage IV breast cancer. Fifteen patients were offered palliative chemotherapy and 85 were offered adjuvant chemotherapy. Patients in the group treated with W. somnifera root extract and chemotherapy had less fatigue than did those in the control group (PFS p p p = 0.0001) than in the control group. There was no difference in the haematological parameters or 24-month overall survival for all stages [study 74% versus control 56% ( p = 0.174)]; however, there was a trend for longer survival in the patients treated with W. somnifera root extract plus chemotherapy. Interpretation Addition of W. somnifera to chemotherapy could have a positive effect on fatigue and improve QoL in patients with breast cancer. The effectiveness and toxicity of chemotherapy were not altered. Thus further study with a large sample size, uniform tumour criteria, and risk stratified patients with breast cancer could help to validate our preliminary outcome. Funding RU grant of University Sains Malaysia (2009-02011). The authors declared no conflicts of interest.

Local and Systemic Cardiovascular Effects from Monochromatic Infrared Therapy in Patients with Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Study

Infrared (IR) therapy is used for pain relief in patients with knee osteoarthritis (OA). However, IR's effects on the cardiovascular system remain uncertain. Therefore, we investigated the local and systemic cardiovascular effects of monochromatic IR therapy on patients with knee OA in a double-blind, randomized, placebo-controlled study. Seventy-one subjects with knee OA received one session of 40 min of active or placebo monochromatic IR treatment (with power output of 6.24 W, wavelength of 890 nm, power density of 34.7 mW/cm2 for 40 min, total energy of 41.6 J/cm2 per knee per session) over the knee joints. Heart rate, blood pressure, and knee arterial blood flow velocity were periodically assessed at the baseline, during, and after treatment. Data were analyzed by repeated-measure analysis of covariance. Compared to baseline, there were no statistically significant group x time interaction effects between the 2 groups for heart rate (P = 0.160), blood pressure (systolic blood pressure: P = 0.861; diastolic blood pressure: P = 0.757), or mean arterial blood flow velocity (P = 0.769) in follow-up assessments. The present study revealed that although there was no increase of knee arterial blood flow velocity, monochromatic IR therapy produced no detrimental systemic cardiovascular effects.

Effects of a healthy food supply intervention in a military setting: positive changes in cereal, fat and sugar containing foods

BackgroundIn Finland, all men are liable to military service and a clear majority completes service. The increasing prevalence of obesity also among soldiers concerns conscripts’ food choices. Conscripts are served nutritionally planned regular main meals but individual choices take place in free-time eating. This study assesses the effects in conscripts’ eating habits in an intervention targeting the supply of healthy foods available in the military setting.MethodsParticipants were 604 18-21-year old male conscripts of whom 242 belonged to Control Group and 362 to Intervention Group. Participants of Control Group were historical controls performing military service one year before Intervention Group. The intervention targeted selection, placement, and attractiveness of healthy foods in garrison refectories and soldier’s home cafeterias, the two main food providers in the military. Dietary intake data was collected by self-administered questionnaire at three time points: before/beginning of military service (T0), 8 weeks (T1) and 6 months (T2) of military service. Outcome measures were food consumption frequencies and four dietary indexes (Cereal Index, Fruit and Vegetable Index, Fat Index and Sugar Index) developed to characterize the diet. Changes between study groups in outcome variables and in time were analysed by repeated-measures analysis of covariance.ResultsSignificant (p < 0.05) intervention effects and time-intervention interactions mostly in favor of Intervention Group were found. In Intervention Group, Cereal Index was significantly higher at T2 and the overall level of porridges and cereals was higher during follow-up when comparing to Control Group. Also, the overall levels of Fat Index, potato chips, soft drinks and desserts as well as sweet pastries at T1 were significantly lower in Intervention Group. At the same time, Fruit and Vegetable Index and the level of fruit and berries were lower in Intervention Group during follow-up.ConclusionsIn the military setting, healthier food choices can be promoted by intervening on the main food environments by improving the supply of healthy foods. However, impacting on conscripts’ individual selection as fruit and vegetable consumption is more challenging.