Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial

Objective

We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB), and evaluated the acceptance of the video.

Trial Design

Randomized controlled trial.

Methods

We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania). They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100) or standard of care (control group, n = 100). Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups.

Results

Median age was 39.1 years (interquartile range 37.0–50.0); 94 (47%) were females, 106 (53%) were males, and 49 (24.5%) were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7–65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2–32.5%, in the control group, p <0.0001), an increase in volume of specimen defined as a volume ≥3ml (78%, 95% CI 68.6–85.7%, versus 45%, 95% CI 35.0–55.3%, p <0.0001), and specimens less likely to be salivary (14%, 95% CI 7.9–22.4%, versus 39%, 95% CI 29.4–49.3%, p = 0.0001). Older age, but not the HIV status or sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%). Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%).

Conclusions

Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum samples. If confirmed in larger studies, instructional videos may have a substantial effect on the case yield using sputum microscopy and also molecular tests. This low-cost strategy should be considered as part of the efforts to control TB in resource-limited settings.

Trial Registration

Pan African Clinical Trials Registry PACTR201504001098231     

Acute effect of whole-body vibration on sprint and jumping performance in elite skeleton athletes

The winter sliding sport known as skeleton requires athletes to produce a maximal sprint followed by high speed sliding down a bobsled track. Athletes are required to complete the course twice in 1 hour and total time for the 2 runs determines overall ranking. The purpose of this investigation was to examine the effect of whole-body vibration (WBV) on lower body power to explore the utility of WBV as an ergogenic aid for skeleton competition. Elite skeleton athletes (1 male and 6 females) completed an unloaded squat jump (SQJ) immediately followed by 2 countermovement jumps (CMJs) and a maximal 30-m sprint before and after WBV or no vibration (CON) using a crossover design. The second 30-m sprint was slower following both CON (1.4% decrement; p = 0.05) and WBV (0.7% decrement; p = 0.03). Mean vertical velocity was maintained following WBV in the SQJ but decreased following CON (p = 0.03). There was a trend for athletes to commence the SQJ from a higher starting stance post-WBV compared to CON (p = 0.08). WBV decreased total vertical distance traveled compared to CON in the SQJ (p = 0.006). WBV had little effect on peak velocity, jump height, dip, and peak acceleration or any CMJ parameters. When sprint athletes' warm up and perform maximal jumps and a 30-m sprint with 15-20 minutes of recovery before repeating the sequence, the second series of performances tend to be compromised. However, when WBV is used before the second series of efforts, some aspects of maximal jumping and sprinting appear to be influenced in a beneficial manner. Further research is required to explore whether WBV can improve the second sprint for athletes in actual competition and/or what sort of WBV protocol is optimal for these populations.     

The effect of warm-up with whole-body vibration vs. cycle ergometry on isokinetic dynamometry

The purpose of this study was to compare the effects of warm-up protocols using either whole-body vibration (WBV) or cycle ergometry (CE) on peak torque at 3 different isokinetic speeds and on fatigue in the knee extension exercise. Twenty-seven recreationally trained (age = 23.59 ± 3.87 years) men (n = 14) and women (n = 13) were tested at 3 different isokinetic speeds (60, 180, 300°·s-1) after either WBV or CE warm-up. The WBV consisted of intermittent bouts of 30 seconds of isometric squats at various degrees of hip and knee flexion for a total of 5 minutes. The CE consisted of 5 minutes of pedaling a cycle ergometer at 65-85% of age-predicted max heart rate. Comparisons between the warm-up conditions were analyzed using repeated measures analysis of variance. For the fatigue comparison, subjects completed 50 continuous concentric knee extensions at 240°·s-1. Means from the first 3 repetitions were compared to means from the final 3 repetitions to establish a fatigue index. Conditions were compared through an independent T-test. No significant (p > 0.05) differences were discovered between warm-up conditions at any speed or on the fatigue index. Means were virtually identical at 60°·s-1 (WBV = 142.14 ± 43.61 ft lb-1; CE = 140.64 ± 42.72 ft lb-1), 180° s-1 (WBV = 93.88 ± 35.18 ft lb-1; CE = 96.36 ± 31.53 ft lb-1), and 300°·s-1 (WBV = 78.36 ± 26.04 ft lb-1; CE = 80.13 ± 26.08), and on fatigue percentage (WBV = 51.14 ± 10.06%; CE = 52.96 ± 9.19%). These data suggest that the more traditional 5-minute cycle ergometer warm-up elicits results comparable to a less common vibration warm-up. The findings of this study are that these modalities are comparable under the tested conditions.     

High-intensity interval training vs. repeated-sprint training in tennis

The aim of this study was to compare the effects of high-intensity interval training (HIIT) and repeated-sprint training (RST) on aerobic fitness, tennis-specific endurance, linear and repeated-sprint ability (RSA), and jumping ability. Thirty-one competitive male tennis players took part in a training intervention of 6 weeks. The players were matched into 3 groups, HIIT (n = 11), RST (n = 12), or control group (CON, n = 9). The results showed significant time × intervention interactions for VO(2)peak, with a significant increase in the VO(2)peak level of 6.0% in HIIT (p = 0.008) and 4.9% in RST (p = 0.010), whereas no changes occurred in CON. However, the following differences were found between the intervention groups: The HIIT-induced greater improvements in tennis-specific endurance (HIIT 28.9% vs. RST 14.5%; p < 0.05) and RST led to a significant improvement in RSA (i.e., reduction in the mean sprint time of 3.8%; p < 0.05). Neither training strategy induced any effects on jumping and sprinting abilities. Both training interventions showed similar improvements in general aerobic fitness. Also, the present results suggest that RST represents a time-efficient stimulus for a simultaneous improvement of general and tennis-specific aerobic fitness as well for RSA.     

Effects of an Exercise Programme on Functional Capacity,Body Composition and Risk of Falls in Patients with Cirrhosis: A Randomized Clinical Trial

Patients with cirrhosis often have functional limitations, decreased muscle mass, and a high risk of falls. These variables could improve with exercise. The aim was to study the effects of moderate exercise on functional capacity, body composition and risk of falls in patients with cirrhosis. Twenty-three cirrhotic patients were randomized to an exercise programme (n = 14) or to a relaxation programme (n = 9). Both programmes consisted of a one-hour session 3 days a week for 12 weeks. At the beginning and end of the study, we measured functional capacity using the cardiopulmonary exercise test, evaluated body composition using anthropometry and dual energy X-ray absorptiometry, and estimated risk of falls using the Timed Up&Go test. In the exercise group, cardiopulmonary exercise test showed an increase in total effort time (p<0.001) and ventilatory anaerobic threshold time (p = 0.009). Upper thigh circumference increased and mid-arm and mid-thigh skinfold thickness decreased. Dual energy X-ray absorptiometry showed a decrease in fat body mass (-0.94 kg, 95%CI -0.48 to -1.41, p = 0.003) and an increase in lean body mass (1.05 kg, 95%CI 0.27 to 1.82, p = 0.01), lean appendicular mass (0.38 kg, 95%CI 0.06 to 0.69, p = 0.03) and lean leg mass (0.34 kg, 95%CI 0.10 to 0.57, p = 0.02). The Timed Up&Go test decreased at the end of the study compared to baseline (p = 0.02). No changes were observed in the relaxation group. We conclude that a moderate exercise programme in patients with cirrhosis improves functional capacity, increases muscle mass, and decreases body fat and the Timed Up&Go time.Trial Registration: ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01447537","term_id":"NCT01447537"}}NCT01447537     

THE ACUTE EFFECT OF WHOLE BODY VIBRATION TRAINING ON FLEXIBILITY AND EXPLOSIVE STRENGTH OF YOUNG GYMNASTS

The purpose of this study was to examine the acute effect of a single bout of whole body vibration (WBV) on flexibility and explosive strength of lower limbs in young artistic gymnasts. Thirty-two young competitive gymnasts volunteered to participate in this study, and were allocated to either the vibration group or traditional body weight training according to the vibration protocol. The vibration intervention consisted of a single bout of eccentric and concentric squatting movements on a vibration platform that was turned on (vibration group: VG n = 15), whereas the traditional body weight (no vibration) group performed the same training protocol with the WBV device turned off (NVG: n= 17). Flexibility (sit and reach test) and explosive strength tests [squat jump (SJ), counter movement jump (CMJ), and single leg squat (right leg (RL) and left leg (LL))] were performed initially (pre-test), immediately after the intervention (post-test 1), and 15 minutes after the end of the intervention programme (post-test 15). Four 2x3 ANOVAs were used to examine the interaction between group (VG vs NVG) and time (pre, post 1, and post 15) with respect to examined variables. The results revealed that a significant interaction between group and time was found with respect to SJ (p < 0.05). However, no significant interaction between group and time was found with respect to flexibility, CMJ, RL and LL after the end of the intervention programme (p > 0.05). Further, the percentage improvement of the VG was significantly greater in all examined variables compared to the NVG. This study concluded that WBV training improves flexibility and explosive strength of lower limbs in young trained artistic gymnasts and maintains the initial level of performance for at least 15 minutes after the WBV intervention programme.     

A Multicenter,Randomized, Double-Blind,Placebo-Controlled Trial of High-Dose Rebamipide Treatment for Low-Dose Aspirin-Induced Moderate-to-Severe Small Intestinal Damage

Background

Low-dose aspirin (LDA) frequently causes small bowel injury. While some drugs have been reported to be effective in treating LDA-induced small intestinal damage, most studies did not exclude patients with mild damage thought to be clinically insignificant.

Aim

We conducted a multicenter, randomized, double-blind, placebo-controlled trial to assess the efficacy of a high dose of rebamipide, a gastroprotective drug, for LDA-induced moderate-to-severe enteropathy.

Methods

We enrolled patients who received 100 mg of enteric-coated aspirin daily for more than 3 months and were found to have more than 3 mucosal breaks (i.e., erosions or ulcers) in the small intestine by capsule endoscopy. Eligible patients were assigned to receive either rebamipide 300 mg (triple dose) 3 times daily or placebo for 8 weeks in a 2:1 ratio. Capsule endoscopy was then repeated. The primary endpoint was the change in the number of mucosal breaks from baseline to 8 weeks. Secondary endpoints included the complete healing of mucosal breaks at 8 weeks and the change in Lewis score (an endoscopic score assessing damage severity) from baseline to 8 weeks.

Results

The study was completed by 38 patients (rebamipide group: n = 25, placebo group: n = 13). After 8 weeks of treatment, rebamipide, but not placebo, significantly decreased the number of mucosal breaks (p = 0.046). While the difference was not significant (p = 0.13), the rate of complete mucosal break healing in the rebamipide group (32%, 8 of 25) tended to be higher than that in the placebo group (7.7%, 1 of 13). Rebamipide treatment significantly improved intestinal damage severity as assessed by the Lewis score (p = 0.02), whereas placebo did not. The triple dose of rebamipide was well tolerated.

Conclusions

High-dose rebamipide is effective for the treatment of LDA-induced moderate-to-severe enteropathy.

Trial Registration

UMIN Clinical Trials Registry UMIN000003463     

Protection against muscle damage following fifty drop jumps conferred by ten drop jumps

This study investigated whether 10 drop jumps (DJs) would confer protective effect against muscle damage and soreness in a subsequent bout of 50 DJs. Sixteen men were randomly placed into either a group performing 1 set of 10 DJs followed by 5 sets of 10 DJs (10-50, n = 8) or another group performing 2 bouts of 5 sets of 10 DJs (50-50, n = 8) separated by 2 weeks. The DJs were performed from a box height of 0.6 m, with a 10-second interval between jumps and a 1-minute rest between sets. Jump height, peak vertical ground reaction force, ground contact time, and heart rate during DJs were measured, and blood lactate concentration was assessed before and immediately after DJs. Changes in maximal isometric (ISO) and isokinetic concentric torque (CON), vertical jump, muscle soreness, and plasma creatine kinase activity before, immediately after, and at 1, 24, 48, and 72 hours following exercise were compared between groups for the first and second bouts and between the bouts by a 2-way repeated-measures analysis of variance. Changes in ISO, CON, vertical jump, and muscle soreness were significantly (p < 0.05) smaller for 10 DJs compared with 50 DJs; however, no significant differences in the measures between groups were evident following the second bout. The changes in the measures following 50 DJs in the 10-50 group were significantly (p < 0.05) smaller than those following the first bout of the 50-50 group. These results suggest that 10 DJs and 50 DJs conferred the same magnitude of protective effect against muscle damage by 50 DJs.     

Effect of different rest intervals after whole-body vibration on vertical jump performance

Whole-body vibration (WBV) may potentiate vertical jump (VJ) performance via augmented muscular strength and motor function. The purpose of this study was to evaluate the effect of different rest intervals after WBV on VJ performance. Thirty recreationally trained subjects (15 men and 15 women) volunteered to participate in 4 testing visits separated by 24 hours. Visit 1 acted as a familiarization visit where subjects were introduced to the VJ and WBV protocols. Visits 2-4 contained 2 randomized conditions per visit with a 10-minute rest period between conditions. The WBV was administered on a pivotal platform with a frequency of 30 Hz and an amplitude of 6.5 mm in 4 bouts of 30 seconds for a total of 2 minutes with 30 seconds of rest between bouts. During WBV, subjects performed a quarter squat every 5 seconds, simulating a countermovement jump (CMJ). Whole-body vibration was followed by 3 CMJs with 5 different rest intervals: immediate, 30 seconds, 1 minute, 2 minutes, or 4 minutes. For a control condition, subjects performed squats with no WBV. There were no significant (p > 0.05) differences in peak velocity or relative ground reaction force after WBV rest intervals. However, results of VJ height revealed that maximum values, regardless of rest interval (56.93 ± 13.98 cm), were significantly (p < 0.05) greater than the control condition (54.44 ± 13.74 cm). Therefore, subjects' VJ height potentiated at different times after WBV suggesting strong individual differences in optimal rest interval. Coaches may use WBV to enhance acute VJ performance but should first identify each individual's optimal rest time to maximize the potentiating effects.     

A Randomized Controlled Trial of Multicomponent Exercise in Older Adults with Mild Cognitive Impairment

Background

To examine the effect of multicomponent exercise program on memory function in older adults with mild cognitive impairment (MCI), and identify biomarkers associated with improvement of cognitive functions.

Methodology/Principal Findings

Subjects were 100 older adults (mean age, 75 years) with MCI. The subjects were classified to an amnestic MCI group (n = 50) with neuroimaging measures, and other MCI group (n = 50) before the randomization. Subjects in each group were randomized to either a multicomponent exercise or an education control group using a ratio of 1∶1. The exercise group exercised for 90 min/d, 2 d/wk, 40 times for 6 months. The exercise program was conducted under multitask conditions to stimulate attention and memory. The control group attended two education classes. A repeated-measures ANOVA revealed that no group × time interactions on the cognitive tests and brain atrophy in MCI patients. A sub-analysis of amnestic MCI patients for group × time interactions revealed that the exercise group exhibited significantly better Mini-Mental State Examination (p = .04) and logical memory scores (p = .04), and reducing whole brain cortical atrophy (p<.05) compared to the control group. Low total cholesterol levels before the intervention were associated with an improvement of logical memory scores (p<.05), and a higher level of brain-derived neurotrophic factor was significantly related to improved ADAS-cog scores (p<.05).

Conclusions/Significance

The results suggested that an exercise intervention is beneficial for improving logical memory and maintaining general cognitive function and reducing whole brain cortical atrophy in older adults with amnestic MCI. Low total cholesterol and higher brain-derived neurotrophic factor may predict improvement of cognitive functions in older adults with MCI. Further studies are required to determine the positive effects of exercise on cognitive function in older adults with MCI.

Trial Registration

UMIN-CTR UMIN000003662 ctr.cgi&quest;function&hairsp;&equals;&hairsp;brows&amp;action&hairsp;&equals;&hairsp;brows&amp;type&hairsp;&equals;&hairsp;summary&amp;recptno&hairsp;&equals;&hairsp;R000004436&amp;language&hairsp;&equals;&hairsp;J.     

Effects of whole body vibration on outer hair cells’ hearing response to distortion product otoacoustic emissions

Whole body vibration (WBV) is one of the most vexing problems in industries. There is a debate about the effect of WBV exposure on hearing system as vibration-induced hearing loss. The purpose of this study was to investigate outer hair cells' (OHCs') hearing response hearing response to distortion product otoacoustic emissions (DPOAEs) in rabbits exposed to WBV. It was hypothesized that the DPOAE response amplitudes (A(dp)) in rabbits exposed to WBV would be lower than those in control rabbits not exposed to WBV. New Zealand white (NZW) rabbits as vibration group (n = 6, exposed to WBV in the z-axis at 4-8 Hz and 1.0 ms(-2) root mean square for 8 h per day during five consecutive days) and NZW rabbits as control group (n = 6, not exposed to any WBV) were participated. A(dp) and noise floor levels (L(nf)) were examined on three occasions: day 0 (i.e., baseline), day 8 (i.e., immediately 1 h after exposure), and day 11 (i.e., 72 h following exposure) with f(2) frequencies ranging from 500 to 10,000 Hz and primaries L(1) and L(2) levels of 65 and 55 dB sound pressure level, respectively. Main effects were statistically found to be significant for group, time, and frequency (p < 0.05). DPOAE amplitudes were significantly larger for rabbits exposed to WBV, larger on day 8 and larger for mid to high f(2) frequencies (at and above 5,888.50 Hz). Main effects were not statistically found to be significant for ear (p > 0.05). Also, four statistically significant interactions including time by ear, time by frequency, group by frequency, and group by time were detected (p < 0.05). Contrary to the main hypothesis, DPOAE amplitudes were significantly larger for rabbits exposed to WBV. WBV exposure significantly led to enhanced mean A(dp) at mid to high frequencies rather than at low ones.     

Influence of Granulocyte-Macrophage Colony-Stimulating Factor or Influenza Vaccination on HLA-DR,Infection and Delirium Days in Immunosuppressed Surgical Patients: Double Blind,Randomised Controlled Trial

Purpose

Surgical patients are at high risk for developing infectious complications and postoperative delirium. Prolonged infections and delirium result in worse outcome. Granulocyte-macrophage colony-stimulating factor (GM-CSF) and influenza vaccination are known to increase HLA-DR on monocytes and improve immune reactivity. This study aimed to investigate whether GM-CSF or vaccination reverses monocyte deactivation. Secondary aims were whether it decreases infection and delirium days after esophageal or pancreatic resection over time.

Methods

In this prospective, randomized, placebo-controlled, double-blind, double dummy trial setting on an interdisciplinary ICU of a university hospital 61 patients with immunosuppression (monocytic HLA-DR [mHLA-DR] <10,000 monoclonal antibodies [mAb] per cell) on the first day after esophageal or pancreatic resection were treated with either GM-CSF (250 μg/m²/d), influenza vaccination (Mutagrip 0.5 ml/d) or placebo for a maximum of 3 consecutive days if mHLA-DR remained below 10,000 mAb per cell. HLA-DR on monocytes was measured daily until day 5 after surgery. Infections and delirium were followed up for 9 days after surgery. Primary outcome was HLA-DR on monocytes, and secondary outcomes were duration of infection and delirium.

Results

mHLA-DR was significantly increased compared to placebo (p < 0.001) and influenza vaccination (p < 0.001) on the second postoperative day. Compared with placebo, GM-CSF-treated patients revealed shorter duration of infection (p < 0.001); the duration of delirium was increased after vaccination (p = 0.003).

Conclusion

Treatment with GM-CSF in patients with postoperative immune suppression was safe and effective in restoring monocytic immune competence. Furthermore, therapy with GM-CSF reduced duration of infection in immune compromised patients. However, influenza vaccination increased duration of delirium after major surgery.

Trial Registration

www.controlled-trials.com ISRCTN27114642     

Effects of an Internet-Based Cognitive Behavioral Therapy (iCBT) Program in Manga Format on Improving Subthreshold Depressive Symptoms among Healthy Workers: A Randomized Controlled Trial

Objective

The purpose of this study was to develop a new Internet-based computerized cognitive behavior therapy (iCBT) program in Manga format, the Japanese cartoon, for workers and to examine the effects of the iCBT program on improving subthreshold depression using a randomized controlled trial (RCT) design among workers employed in private companies in Japan.

Method

All workers in a company (n = 290) and all workers in three departments (n = 1,500) at the headquarters of another large company were recruited by an invitation e-mail. Participants who fulfilled the inclusion criteria were randomly allocated to intervention or control groups (N = 381 for each group). A six-week, six-lesson iCBT program using Manga (Japanese comic) story was developed. The program included several CBT skills: self-monitoring, cognitive restructuring, assertiveness, problem solving, and relaxation. The intervention group studied the iCBT program at a frequency of one lesson per week. Depression (Beck Depression Inventory II; BDI-II) was assessed as a primary outcome at baseline, and three- and six-month follow-ups for both intervention and control groups were performed.

Results

The iCBT program showed a significant intervention effect on BDI-II (t = −1.99, p<0.05) with small effect sizes (Cohen''s d: −0.16, 95% Confidence Interval: −0.32 to 0.00, at six-month follow-up).

Conclusions

The present study first demonstrated that a computerized cognitive behavior therapy delivered via the Internet was effective in improving depression in the general working population. It seems critical to improve program involvement of participants in order to enhance the effect size of an iCBT program.

Trial Registration

UMIN Clinical Trials Registry UMIN000006210 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000007341&type=summary&language=E     

Internet-Based Brief Intervention to Prevent Unhealthy Alcohol Use among Young Men: A Randomized Controlled Trial

Introduction

Alcohol use is one of the leading modifiable morbidity and mortality risk factors among young adults.

Study Design

2 parallel-group randomized controlled trial with follow-up at 1 and 6 months.

Setting/Participants

Internet based study in a general population sample of young men with low-risk drinking, recruited between June 2012 and February 2013.Intervention: Internet-based brief alcohol primary prevention intervention (IBI). The IBI aims at preventing an increase in alcohol use: it consists of normative feedback, feedback on consequences, calorific value alcohol, computed blood alcohol concentration, indication that the reported alcohol use is associated with no or limited risks for health. Intervention group participants received the IBI. Control group (CG) participants completed only an assessment.

Main Outcome Measures

Alcohol use (number of drinks per week), binge drinking prevalence. Analyses were conducted in 2014–2015.

Results

Of 4365 men invited to participate, 1633 did so; 896 reported low-risk drinking and were randomized (IBI: n = 451; CG: n = 445). At baseline, 1 and 6 months, the mean (SD) number of drinks/week was 2.4(2.2), 2.3(2.6), 2.5(3.0) for IBI, and 2.4(2.3), 2.8(3.7), 2.7(3.9) for CG. Binge drinking, absent at baseline, was reported by 14.4% (IBI) and 19.0% (CG) at 1 month and by 13.3% (IBI) and 13.0% (CG) at 6 months. At 1 month, beneficial intervention effects were observed on the number of drinks/week (p = 0.05). No significant differences were observed at 6 months.

Conclusion

We found protective short term effects of a primary prevention IBI.

Trial Registration

Controlled-Trials.com ISRCTN55991918     

Discontinuation of adalimumab after attaining disease activity score 28-erythrocyte sedimentation rate remission in patients with rheumatoid arthritis (HONOR study): an observational study

Introduction

Evidences of biologics-free disease control after discontinuing adalimumab (ADA) in rheumatoid arthritis (RA) patients in clinical practice have not been sufficiently investigated. Purpose of this study is to investigate whether disease activity score 28 (DAS28)- erythrocyte sedimentation rate (ESR) remission was preserved after discontinuation of ADA in patients with RA.

Methods

This is an observational but not a randomized controlled study. Among 197 RA patients who initiated with combination of ADA with concomitant MTX, 69 (35%) acquired DAS28 (ESR) < 2.6 for at least 24 weeks. Of those 69 patients, 51 went on ADA discontinuation with their consent, and finally 50 of those with follow-up of > 24 weeks were evaluated. The effect of discontinuing ADA on clinical disease activity, functional disability and radiographic progression were evaluated by DAS28 (ESR), the clinical disease activity index (CDAI) and the simplified disease activity index (SDAI), by a health assessment questionnaire-disability index (HAQ-DI) and by the modified total Sharp score (mTSS), respectively.

Results

The mean age of the participants was 59.5 years with the mean disease duration of 7.1 years. Out of the 50 patients, 29 (58%) were maintained in DAS28 (ESR) < 2.6 at 24 weeks after discontinuing ADA. A logistic regression analysis showed that DAS28 (ESR) at baseline significantly predicted a DAS28 (ESR) < 2.6 maintained after discontinuation of ADA, and a receiver-operating characteristic (ROC) analysis showed that the cut-off value of DAS28 (ESR) at discontinuation was 2.16. The mean HAQ-DI at six months after discontinuing ADA was 0.1 in patients who kept in DAS28 (ESR) < 2.6, and 94.9% (37/39) showed no evidence of radiographic progression (> 0.5 per year of a change in mTSS) at 1 year.

Conclusions

It was possible to maintain DAS28 (ESR) < 2.6 after discontinuation of ADA without functional and radiographic progression and very low DAS28 (ESR) at the discontinuation was associated with successful ADA-free DAS28 (ESR) < 2.6 in patients with RA.

Trial registration

University Hospital Medical Information Network Identifier: UMIN000006669.     

Effect of whole body vibration training on lower limb performance in selected high-level ballet students

The aim of this study was to examine the effects of 8 weeks of whole body vibration (WBV) training on vertical jump ability (CMJ) and knee-extensor performance at selected external loads (50, 70, and 100 kg; leg-press exercise) in elite ballerinas. Twenty-two (age, 21.25 +/- 1.5 years) full-time ballerinas were assigned randomly to the experimental (E, n = 11) and control (C, n = 11) groups. The experimental group was submitted to WBV training 3 times per week before ballet practice. During the training period, the E and C groups undertook the same amount of ballet practice. Posttraining CMJ performance significantly increased in E group (6.3 +/- 3.8%, p < 0.001). Furthermore, E group showed significant (p < 0.05-0.001) posttraining average leg-press power and velocity improvements at all the external loads considered. Consequently, the force-velocity and power-velocity relationship shifted to the right after WBV training in the E group. The results of the present study show that WBV training is an effective short-term training methodology for inducing improvements in knee-extensor explosiveness in elite ballerinas.     

The effect of whole-body vibration training and conventional strength training on performance measures in female athletes

The purpose of this study was to examine the effects of regular whole-body vibration (WBV) training on lower body strength and power. National Collegiate Athletic Association Division III softball athletes (n = 9) completed the 9-week protocol as part of their off-season strength and conditioning program. The athletes were randomly assigned to 1 of 2 groups. Week 1, pretesting included 3 repetition maximum (3RM) back squat, standing long jump (SLJ), and vertical countermovement jump (VCMJ). Phase I training (weeks 2-4) consisted of either WBV training (group 1) or conventional strength training (CST, group 2). The primary programmatic difference between WBV and CST was the inclusion of WBV sets after squat sets. Posttesting (3RM squat, SLJ, VCMJ) occurred at week 5. Phase II training (weeks 6-8) consisted of either WBV training (group 2) or CST (group 1). Posttesting was repeated at week 9 after the completion of phase II. Three 2 × 2 mixed factorial analyses of variance were computed. No significant differences (p > 0.05) were found between groups or between groups and testing period for the SLJ, VCMJ, and estimated 1RM back squat. Increases (p < 0.05) were observed in SLJ, VCMJ, and back squat from pretest to posttest 1. Back squat increased (p < 0.05) from posttest 1 to posttest 2. All the athletes experienced significantly greater (p < 0.05) percent changes from pretest to posttest 1 for SLJ and VCMJ. These results indicate that the inclusion of WBV as part of an off-season strength and conditioning program has no apparent benefit over CST methods for collegiate softball players.     

Determining the optimal whole-body vibration dose-response relationship for muscle performance

Da Silva-Grigoletto, ME, de Hoyo, M, Sa?udo, B, Corrales, L, and García-Manso, JM. Determining the optimal whole-body vibration dose-response relationship for muscle performance. J Strength Cond Res 25(12): 3326-3333, 2011-The aim of this investigation was twofold: first, to determine the optimal duration of a single whole-body vibration (WBV) exposure (phase 1) and second to find out the ideal number of sets per intervention to maximize muscle performance (phase 2). All participants were young (age: 19.4 ± 1.6 years), healthy, physically active men. In both studies, a 30-Hz frequency and a 4-mm peak-to-peak displacement were used. In phase 1, subjects (n = 30) underwent 3 sets of different durations (30, 60, and 90 seconds), whereas in phase 2, subjects (n = 27) underwent 3 interventions where the duration remained fixed at 60 seconds, and the number of sets performed (3, 6, or 9) was modified. The recovery time between sets was set at 2 minutes. In all interventions, each set consisted of 1 isometric repetition in a squat position with knees flexed at 100°. Before and after each session, jump height (countermovement jump [CMJ] and squat jump [SJ]) and power output in half squat (90° knee flexion) were assessed. In phase 1, an improvement in jump ability and power output was observed after the 30- and 60-second intervention (p < 0.01), whereas the 90 second intervention, participants just experienced a decrease in SJ and CMJ (p < 0.05). When comparing the different protocols, the greatest response was achieved using 60 seconds (p < 0.05), which was therefore considered as the optimal duration to be used in phase 2. In the second phase, improvements in jump ability and power output were found with 3 and 6 sets (p < 0.05), whereas with 9 sets, participants actually experienced a decrease in these variables. Intergroup comparison showed a greater effect for the program of 6 sets (p < 0.05). In conclusion, a WBV intervention consisting of six 60-second sets produces improved muscle performance measured by SJ, CMJ, and power output.     

Safety and Immunogenicity of H1/IC31?, an Adjuvanted TB Subunit Vaccine,in HIV-Infected Adults with CD4+ Lymphocyte Counts Greater than 350 cells/mm3: A Phase II,Multi-Centre,Double-Blind,Randomized, Placebo-Controlled Trial

Background

Novel tuberculosis vaccines should be safe, immunogenic, and effective in various population groups, including HIV-infected individuals. In this phase II multi-centre, double-blind, placebo-controlled trial, the safety and immunogenicity of the novel H1/IC31 vaccine, a fusion protein of Ag85B-ESAT-6 (H1) formulated with the adjuvant IC31, was evaluated in HIV-infected adults.

Methods

HIV-infected adults with CD4+ T cell counts >350/mm³ and without evidence of active tuberculosis were enrolled and followed until day 182. H1/IC31 vaccine or placebo was randomly allocated in a 5∶1 ratio. The vaccine was administered intramuscularly at day 0 and 56. Safety assessment was based on medical history, clinical examinations, and blood and urine testing. Immunogenicity was determined by a short-term whole blood intracellular cytokine staining assay.

Results

47 of the 48 randomised participants completed both vaccinations. In total, 459 mild or moderate and 2 severe adverse events were reported. There were three serious adverse events in two vaccinees classified as not related to the investigational product. Local injection site reactions were more common in H1/IC31 versus placebo recipients (65.0% vs. 12.5%, p = 0.015). Solicited systemic and unsolicited adverse events were similar by study arm. The baseline CD4+ T cell count and HIV viral load were similar by study arm and remained constant over time. The H1/IC31 vaccine induced a persistent Th1-immune response with predominately TNF-α and IL-2 co-expressing CD4+ T cells, as well as polyfunctional IFN-γ, TNF-α and IL-2 expressing CD4+ T cells.

Conclusion

H1/IC31 was well tolerated and safe in HIV-infected adults with a CD4+ Lymphocyte count greater than 350 cells/mm³. The vaccine did not have an effect on CD4+ T cell count or HIV-1 viral load. H1/IC31 induced a specific and durable Th1 immune response.

Trial registration

Pan African Clinical Trials Registry (PACTR) PACTR201105000289276