Significant Within-group Changes Research Articles

The Effects of Exergame Telerehabilitation in Persons With Subjective Cognitive Decline.

The primary aim of this Stage IB randomized controlled trial (RCT) was to test the preliminary effects of a dual-task exergaming telerehabilitation intervention on cognition and aerobic fitness, compared to aerobic exercise (AEx) only and attention control (stretching) in older adults with subjective cognitive decline. This RCT randomized 39 participants on a 2:1:1 allocation ratio to supervised exergame (n = 20), AEx (n = 11), and stretching (n = 8) for 12 weeks. The dual-task exergaming was concurrent moderate-intensity cycling and BrainFitRx cognitive telerehabilitation. Cognition was assessed by NIH Toolbox Cognitive Battery and aerobic fitness by 6-minute walk test (6MWT) and shuttle walk test. The participants were 74.6 (7.4) years old and 69% were female. The effect of time was significant, F(1, 23.9) = 13.16, p = .001, for the Fluid Composite score, and significant within-group changes were seen for the exergame group, t(14.08) = 2.53, p = .024, d = 0.33. Between-group changes did not reach significant levels for any cognitive test. Between-group changes for the 6MWT were not significant. The exergame participants further improved their fluid cognition, whereas the AEx and stretching groups did not, indicating a potential synergistic effect from AEx and cognitive training. The aerobic fitness changes were similar between the exergame and AEx-only groups, indicating that the feasibility of adding cognitive training to AEx concurrently without sacrificing gains in aerobic fitness from AEx. This study shows the flexibility of exergame delivery and its potentially therapeutic effects in persons at risk for Alzheimer's dementia. NCT04311736.

Effects of proactive healthcare on pain, physical and activities of daily living functioning in vulnerable older adults with chronic pain: a pragmatic clinical trial with one- and two-year follow-up.

To investigate the changes in pain, physical and activities of daily living (ADL) functioning in vulnerable older adults with chronic pain after proactive primary care intervention. This study was embedded in a prospective, pragmatic, matched-control multicenter trial at 19 primary care practices in Sweden, with proactive medical and social care (Intervention Group, IG, n = 134) in comparison with usual care (Control Group, CG, n = 121). Patients with chronic pain, defined as pain experienced longer than 3months, were included in this subgroup analysis. Data on pain aspects, physical and ADL functioning were collected in the questionnaires at baseline, one- and two-year follow-up (FU-1 and FU-2). Data on prescribed pain medications was collected by local health authorities. Mean age was 83.0 ± 4.7years with almost equal representation of both genders. From baseline until FU-2, there were no significant within-group or between-group changes in pain intensity. Small adjustments of pain medication prescriptions were made in both groups. Compared to FU-1, the functional changes were more measurable at FU-2 as fewer participants had impaired physical functioning in IG (48.4%) in comparison to CG (62.6%, p = 0.027, Effect Size φ = 0.14). Higher scores of ADL-staircase (more dependent) were found in both groups (p < 0.01, Effect Size r = 0.24 in CG and r = 0.16 in IG). Vulnerable older adults with chronic pain seemed to remain physical and ADL functioning after proactive primary care intervention, but they may need tailored strategies of pain management to improve therapeutic effects. ClinicalTrials.gov 170608, ID: NCT03180606.

The impact of botanical fermented foods on metabolic syndrome and type 2 diabetes: a systematic review of randomised controlled trials.

Our systematic review assessed the impact of botanical fermented food (BFF) consumption on glucose, lipid, anthropometric, inflammatory and gut microbiota parameters, in adults with metabolic syndrome (MetS), MetS components or type 2 diabetes mellitus (T2DM). Embase, MEDLINE, Cochrane CENTRAL and Google Scholar were searched with no language limits, from inception to August 31, 2022, for eligible randomised controlled trials (RCTs). Two independent reviewers screened 6873 abstracts and extracted relevant data. Risk of bias (ROB) was assessed using the Cochrane Collaboration's ROB2 tool. The final review included 26 RCTs, with 31 reports published between 2001 and 2022. Significant (p<0.05) within-group and between-group changes in cardiometabolic outcome means were reported in 23 and 19 studies, respectively. Gut microbiota composition was assessed in four studies, with two finding significant between-group differences. No significant difference between groups of any measured outcomes was observed in five studies. There were 14 studies at low ROB; ten were of some concern; and two were at high ROB. In 73% of included studies, BFF consumption by participants with obesity, MetS or T2DM led to significant between-group improvements in discrete cardiometabolic outcomes, including fasting blood glucose, lipid profile, blood pressure, waist circumference, body fat percentage, and C-reactive protein. BFF consumption increased the abundance of beneficial gut bacteria, such as Bifidobacterium and LAB, whilst reducing potential pathogens like Bacteroides. To determine the clinical significance of BFFs as therapeutic dietary adjuncts, their safety, tolerability and affordability must be balanced with the limited power and magnitude of these preliminary findings.

Safety and Efficacy of Drug Holidays for Women with Sexual Dysfunction Induced by Selective Serotonin Reuptake Inhibitors (SSRIs) Other than Fluoxetine: An Open-Label Randomized Clinical Trial.

Selective serotonin reuptake inhibitors (SSRIs) are the cornerstone of psychopharmacology. However, they cause side effects such as sexual dysfunction, leading to the discontinuation of treatment. We aimed to investigate the efficacy and safety of drug holidays for women experiencing sexual dysfunction Induced by SSRIs other than fluoxetine. This study was an 8-week randomized, open-label, controlled trial including married women aged between 18 and 50 years who had experienced sexual dysfunction while undergoing treatment with SSRIs. The intervention group implemented drug holidays by not taking medications on Thursdays and Fridays, while the control group continued regular medication use. The female sexual function index (FSFI) and the 28-question general health questionnaire (GHQ-28) were administered to assess sexual function and mental health, respectively. A total of 50 participants completed the trial. The drug holidays' group showed significant improvements in arousal (p < 0.001), desire (p = 0.001), orgasm (p < 0.001), satisfaction (p < 0.001), lubrication (p = 0.021), and overall sexual health (p < 0.001). The between-group difference of pain was significant (p < 0.001), despite no significant within-group change. Mental health improved in both groups, despite no significant between-group difference. No major adverse effects were reported. Drug holidays did not introduce immediate safety concerns or significant adverse effects during the timeframe of eight weeks, suggesting that it may be a safe and effective strategy for managing SSRI-induced sexual dysfunction in women, alongside improving mental health. Further research is needed to reach a definitive conclusion.

Longitudinal Development of Sprint Performance and Force-Velocity-Power Characteristics: Influence of Biological Maturation.

Edwards, T, Weakley, J, Banyard, HG, Cripps, A, Piggott, B, Haff, GG, and Joyce, C. Longitudinal development of sprint performance and force-velocity-power characteristics: influence of biological maturation. J Strength Cond Res 37(11): 2178-2184, 2023-This study was designed to investigate the influence of biological maturation on the longitudinal development of sprint performance. Thirty-two subjects performed 2 assessments of maximal sprint performance that were separated by 18 months. Each sprint assessment was measured through a radar gun that collected instantaneous velocity with the velocity-time data used to derive sprint times and force-velocity-power characteristics. The biological maturity of each subject was assessed using a predictive equation, and subjects were grouped according to predicted years from peak height velocity (circa-PHV: -1.0 to 1.0; post-PHV: >1.0). A 2 × 2 mixed model analysis of variance was used to assess group × time interactions, and paired t -tests were used to assess the longitudinal changes for each maturity group. No significant group × time interactions were observed for any sprint time or force-velocity-power characteristic. The circa-PHV group experienced significant within-group changes in maximal theoretical velocity (6.35 vs. 5.47%; effect size [ES] = 1.26 vs. 0.52) and 5-m sprint time (-3.63% vs. -2.94%; ES = -0.64 vs. -0.52) compared with the post-PHV group. There was no significant change in the magnitude of relative theoretical maximum force in either group; however, both the circa-PHV and post-PHV groups significantly improved the orientation of force production at the start of the sprint (RFmax [4.91 vs. 4.46%; ES = 0.79 vs. 0.74, respectively]). Considering these findings, it is recommended that practitioners adopt training methods aimed to improve relative lower-limb force production, such as traditional strength training and sled pulling and pushing, to improve sprint performance and relative theoretical maximum force.

Comparing the impact of two occupational therapy interventions on academic learning outcomes for children with Human Immunodeficiency Virus

INTRODUCTION: The strong association between perinatal HIV infection and poor performance in academic learning is further challenged by various barriers to learning in the South African context of basic education. This study investigated the efficacy of a novel play-informed, caregiver-implemented, home-based intervention (PICIHBI) for improving academic learning in HIV-positive children METHODOLOGY: A single-blinded, randomised comparison group design was selected to compare PICHIBI with conventional one-on-one occupational therapy interventions. Children with HIV aged 5 to 8 years old on ART and their primary caregiver (N=23) were randomly allocated to an intervention group. The primary outcome of academic learning was measured using the Griffiths Mental Developmental Scales-Extended Revised and the short form Beery-Buktenica Visual Motor Integration test, 5th edition at baseline, mid (5 months) and post-intervention (after 10 months RESULTS: At baseline, the total sample (n=23) presented with below-average performance in all assessed academic learning outcomes. Between-group differences for all academic learning outcomes were not significant at mid or post-test assessment points. A statistically significant within-group change in visual motor integration was noted in the PICIHBI from baseline to mid-test (p=.019). In the conventional group, there were statistically significant changes in visual perception from baseline to mid (p=.001) and baseline to post-test (p=.009). The sub scale Performance in the conventional group improved significantly from baseline to mid-test (p=.027 CONCLUSION: While improvements were noted, children in both groups continued to present with academic learning concerns at post-test. These concerns motivate the need for continued monitoring and further investigation into the feasibility and effectiveness of occupational therapy interventions targeting the academic learning challenges of this population Implications for practice This paper adds to an emerging body of evidence aiming to demonstrate the effect of occupational therapy interventions on occupational outcomes for children with perinatal HIV infection. The paper presents a detailed overview of the conceptualisation of learning as an occupational outcome. The paper further presents consideration of the practical challenges linked to the implementation of, adherence to and sustainability of rehabilitation interventions in low to middle-income countries.

Outcomes of Primary Flexor Tendon Repairs in Zones 2 and 3: A Retrospective Cohort Study

The aims of this retrospective cohort study were to present outcomes of zone 2 and 3 primary flexor tendon repairs and to evaluate how clinical outcomes change over time within and between zones of injury at weeks 6, 13, and26. Data were retrieved from a multicenter flexor tendon cohort registry from 2014 to 2021. The inclusion criteria were: (1) adult patients after primary flexor tendon surgery in zone 2 or 3, (2) flexor digitorum profundus laceration of >50%, (3) 4-6 multistrand flexor digitorum profundus core suture, and (4) early active motion protocol. The primary outcome was the range of motion. Secondary outcomes were strength, patient satisfaction on an 11-point Likert scale, and self-reported physical function measured with the Disability of the Arm, Shoulder, and Hand questionnaire 6, 13, and 26 weeks after surgery. We evaluated 33 patients after 39 tendon repairs in zone 3 and 174 repairs in zone 2 of 163 patients. Range of motion significantly improved over time in both zones (P < .001 to .01). Between-group range of motion differences were nonsignificant except for week 26 (P < .001) for the zone 3 group. Hand strength significantly improved in both zones over time (P < .001 to .01), while between-zone strength differences were statistically nonsignificant (P= .37 to .93). Patient satisfaction was generally good to high (mean 6.8 to 8.0 points) with significant within-group changes in both zones (P < .001). There were no relevant between-zone differences in Disability of the Arm, Shoulder, and Hand scores at any time point. Patients had significantly improved clinical outcomes in both zones. The zone of injury significantly affected the total active motion scores at the final assessment after 26 weeks for the zone 3 injuries. For the secondary outcomes hand strength, patient satisfaction, and Disability of the Arm, Shoulder, and Hand scores, we discovered no significant between-group differences. Therapeutic IV.

Effectiveness of an Uncertainty Management Psychoeducation Program for Schizophrenia Caregivers: A Randomized Controlled Trial.

The inconsistent course of schizophrenia causes a long-term experience of uncertainty for individuals and their families. In Turkey, no studies yet exist that have attempted to address this constant uncertainty that is experienced by caregivers of schizophrenic patients. To evaluate the effects of the Uncertainty Management Psychoeducation Program on reducing uncertainty and intolerance to uncertainty, improving psychological well-being, and coping styles in caregivers of patients with schizophrenia. Single-blinded randomized controlled trial. Caregivers of schizophrenia inpatients were recruited from the psychiatry clinic of a university-affiliated hospital. Data were collected between April 2019 and August 2020. Eligible individuals were randomly allocated to one of the two groups: intervention or control. The intervention group had five individual psychoeducation sessions: "Recognizing Uncertainty," "Cognitively Reframing Uncertainty," "Solving Uncertainty-Related Issues," "Dealing with Uncertainty Using Communication Skills," and the "Closing Session." Participants in the control group received the usual care. Uncertainty, intolerance to uncertainty, psychological well-being, and stress coping strategies were measured at two points: at baseline and immediately following the intervention. Hypotheses were tested using the Mann-Whitney U and Wilcoxon tests. A total of 54 participants were recruited. The intervention group's ratings for "seeking social support" and "optimistic approach" were higher than the control group's ratings. Significant within-group changes in terms of "uncertainty" and "optimistic approach" were reported for the intervention group in the post-intervention. In the control group, significant changes were seen in terms of "uncertainty" and "psychological well-being" over time. The Uncertainty Management Psychoeducation Program was found to be effective in reducing the level of uncertainty, increasing their optimistic approach, and seeking social support of caregivers of schizophrenic patients.

Hybrid robot-assisted gait training for motor function in subacute stroke: a single-blind randomized controlled trial

BackgroundRobot-assisted gait training (RAGT) is a practical treatment that can complement conventional rehabilitation by providing high-intensity repetitive training for patients with stroke. RAGT systems are usually either of the end-effector or exoskeleton types. We developed a novel hybrid RAGT system that leverages the advantages of both types.ObjectiveThis single-blind randomized controlled trial evaluated the beneficial effects of the novel RAGT system both immediately after the intervention and at the 3-month follow-up in nonambulatory patients with subacute stroke.MethodsWe recruited 40 patients with subacute stroke who were equally randomized to receive conventional rehabilitation either alone or with the addition of 15 RAGT sessions. We assessed lower-extremity motor function, balance, and gait performance by using the following tools: active range of motion (AROM), manual muscle test (MMT), the Fugl–Meyer Assessment (FMA) lower-extremity subscale (FMA-LE) and total (FMA-total), Postural Assessment Scale for Stroke (PASS), Berg Balance Scale (BBS), Tinetti Performance-Oriented Mobility Assessment (POMA) balance and gait subscores, and the 3-m and 6-m walking speed and Timed Up and Go (TUG) tests. These measurements were performed before and after the intervention and at the 3-month follow-up.ResultsBoth groups demonstrated significant within-group changes in the AROM, MMT, FMA-LE, FMA-total, PASS, BBS, POMA, TUG, and 3-m and 6-m walking speed tests before and after intervention and at the 3-month follow-up (p < 0.05). The RAGT group significantly outperformed the control group only in the FMA-LE (p = 0.014) and total (p = 0.002) assessments.ConclusionAlthough the novel hybrid RAGT is effective, strong evidence supporting its clinical effectiveness relative to controls in those with substantial leg dysfunction after stroke remains elusive.Trial registration The study was registered with an International Standard Randomized Controlled Trial Number, ISRCTN, ISRCTN15088682. Registered retrospectively on September 16, 2016, at https://www.isrctn.com/ISRCTN15088682

Effect of FLAVAnols on bone turnover markers in type 2 diabetes mellitus–post hoc analysis from a 3-month randomized placebo-controlled trial

BACKGROUND: Individuals with type 2 diabetes mellitus (T2DM) have increased fracture risk with high bone mineral density, possibly related to advanced glycation end products (AGEs) accumulation in bone. Flavanol supplementation in postmenopausal women reduced AGEs formation and decreased bone resorption markers. However, to date, these effects have not been investigated in T2DM. OBJECTIVE: We used a post hoc secondary analysis to determine the effect of monomeric and oligomeric flavanols supplementation on bone turnover markers (BTMs) in individuals with T2DM. METHODS: Eighty-three individuals with T2DM, aged 40–85 years, with microalbuminuria were enrolled from 4 trial centers in Rotterdam, the Netherlands, into a randomized, double-blind, placebo-controlled trial with renal vascular health as the primary outcome. Participants were randomized (1:1) to receive either a placebo or 200 mg of monomeric and oligomeric flavanols as intervention for three months. Serum alkaline phosphatase (ALP), type I collagen crosslinked beta C-telopeptide (β-CTx), and type I procollagen-N-propeptide (P1NP) were measured at baseline and three months. ANCOVA was performed on rank transformed BTMs at three months as the outcome, adjusting for baseline BTMs, group, age, sex, and BMI. RESULTS: Baseline characteristics did not differ between the two arms. The adjusted mean change in BTMs at three months was not different between the placebo vs. intervention arm: ALP –0.059 (–0.262–0.145) vs. 0.060 (–0.135–0.356), p = 0.41; β-CTx 0.013 (–0.205–0.231) vs. 0.100 (–0.109–0.310), p = 0.53 and P1NP 0.091 (–0.080–0.262) vs. 0.030 (–0.134–0.195), p = 0.61. There was no significant within-group change in BTMs after three months in both study arms. CONCLUSION: Supplementation with daily 200 mg of flavanols during three months, on top of usual care in individuals with T2DM, did not result in changes in BTMs compared to placebo. Future studies are needed to show whether long-term supplementation in higher dosages may positively affect BTMs in individuals with T2DM.

Effect of an on-site physical therapy on pain, posture, function and composition, and work-related health status in workers in Korea.

The incidence of work-related musculoskeletal disease is increasing despite automated manufacturing processes. To examine the effect of a customized on-site exercise program on pain, posture, body function, body composition, and work-related health status of workers at an auto-parts factory. Fifty-six participants were randomly divided into one of two groups: experimental (EG), which received a customized exercise program that included manual and exercise therapy from physiotherapy at the workplace; and control (CG), which received customized exercise sheets for a self-directed program at home. The program was performed 3 times per week for 12 weeks. Assessments were performed according to numerical rating scale (NRS), Exbody, Selective Functional Movement Assessment (SFMA), InBody, Short-Form-12 version 2 (SF-12v2), and Work Ability Index (WAI), which were evaluated before and after the program. The EG exhibited significant within-group changes in NRS, Exbody, SFMA, SF-12v2, and WAI; the CG exhibited significant within-group changes only in NRS and SFMA (p < 0.05). There were significant between-group differences in NRS, Exbody, SFMA, and WAI (p < 0.05). An on-site program including manual and exercise therapy directed by a physiotherapist among workers at an auto-parts manufacturer was effective in improving pain levels, posture, body function, and work-related health status.

The Effectiveness of a Computer-Tailored Web-Based Physical Activity Intervention Using Fitbit Activity Trackers in Older Adults (Active for Life): Randomized Controlled Trial.

BackgroundPhysical activity is an integral part of healthy aging; yet, most adults aged ≥65 years are not sufficiently active. Preliminary evidence suggests that web-based interventions with computer-tailored advice and Fitbit activity trackers may be well suited for older adults.ObjectiveThe aim of this study was to examine the effectiveness of Active for Life, a 12-week web-based physical activity intervention with 6 web-based modules of computer-tailored advice to increase physical activity in older Australians.MethodsParticipants were recruited both through the web and offline and were randomly assigned to 1 of 3 trial arms: tailoring+Fitbit, tailoring only, or a wait-list control. The computer-tailored advice was based on either participants’ Fitbit data (tailoring+Fitbit participants) or self-reported physical activity (tailoring-only participants). The main outcome was change in wrist-worn accelerometer (ActiGraph GT9X)–measured moderate to vigorous physical activity (MVPA) from baseline to after the intervention (week 12). The secondary outcomes were change in self-reported physical activity measured by means of the Active Australia Survey at the midintervention point (6 weeks), after the intervention (week 12), and at follow-up (week 24). Participants had a face-to-face meeting at baseline for a demonstration of the intervention and at baseline and week 12 to return the accelerometers. Generalized linear mixed model analyses were conducted with a γ distribution and log link to compare MVPA and self-reported physical activity changes over time within each trial arm and between each of the trial arms.ResultsA total of 243 participants were randomly assigned to tailoring+Fitbit (n=78, 32.1%), tailoring only (n=96, 39.5%), and wait-list control (n=69, 28.4%). Attrition was 28.8% (70/243) at 6 weeks, 31.7% (77/243) at 12 weeks, and 35.4% (86/243) at 24 weeks. No significant overall time by group interaction was observed for MVPA (P=.05). There were no significant within-group changes for MVPA over time in the tailoring+Fitbit group (+3%, 95% CI –24% to 40%) or the tailoring-only group (–4%, 95% CI –24% to 30%); however, a significant decline was seen in the control group (–35%, 95% CI –52% to –11%). The tailoring+Fitbit group participants increased their MVPA 59% (95% CI 6%-138%) more than those in the control group. A significant time by group interaction was observed for self-reported physical activity (P=.02). All groups increased their self-reported physical activity from baseline to week 6, week 12, and week 24, and this increase was greater in the tailoring+Fitbit group than in the control group at 6 weeks (+61%, 95% CI 11%-133%).ConclusionsA computer-tailored physical activity intervention with Fitbit integration resulted in improved MVPA outcomes in comparison with a control group in older adults.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12618000646246; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618000646246

Effect of a family-based multimedia intervention on the uptake of faecal immunohistochemical test among South Asian older adults: A cluster-randomised controlled trial

BackgroundColorectal cancer screening, including faecal immunohistochemical test, is an effective method for detecting colorectal cancer early. Nevertheless, faecal immunohistochemical test uptake among South Asian ethnic minorities is low because they have limited knowledge of and face barriers in accessing colorectal cancer screening. Tailored education and appropriate messaging has potential to convey to this population group the importance of colorectal cancer screening. ObjectivesThis study aimed to assess the acceptability and effectiveness of a family-based multimedia intervention to raise awareness of colorectal cancer screening and increase the uptake of faecal immunochemical tests among South Asian older adults. DesignA cluster-randomised controlled trial with a wait-list control group. ParticipantsThree-hundred and twenty dyads of South Asian older adults and their younger family members were recruited at South Asian community centres and non-governmental organisations providing support services to local South Asians in six Hong Kong districts. MethodsGroup allocation of dyads during cluster randomisation was based on the group assignment of the district where they were recruited. The intervention comprised a multimedia health talk, conveying the importance of colorectal cancer screening and support from younger family members in encouraging their older relatives to undergo screening. Site coordinators assisted participants in accessing faecal immunohistochemical test. The primary outcome was increased uptake of faecal immunohistochemical test among South Asian older adults. Secondary outcomes included younger family members' encouragement of their older relatives to undergo faecal immunohistochemical test and their readiness to assist their relatives with the test. Acceptability of the intervention was measured by dyad satisfaction with the intervention. ResultsThe proportion of older adults participating in faecal immunohistochemical testing was significantly higher among intervention dyads compared with controls (71.8% vs 6.8%, p < 0.001). No significant within-group change was observed on the willingness of younger family members in the intervention group to encourage older adults to undergo faecal immunohistochemical test, nor their readiness to assist older adults in doing so, although a decrease in both outcomes was observed among the control group. Most participants (>86%) were satisfied with the intervention. ConclusionsOur findings demonstrate the acceptability and effectiveness of the intervention in enhancing faecal immunohistochemical test uptake among South Asian older adults, and the benefit of using a family-based approach in the implementation of cancer screening interventions for these individuals. Implementation of the intervention as a component of usual care within South Asian communities is recommended.Trial registration ISRCTN72829325, 10 July 2018.

Participatory Ergonomics Intervention to Prevent Work Disability Among Workers with Low Back Pain: A Randomized Clinical Trial in Workplace Setting

Purpose In order to support people with low back pain (LBP) to stay at work, work arrangements are regarded important. This study aimed to evaluate the effectiveness of a workplace intervention using a participatory approach on work disability of workers with ongoing or recurrent LBP. Methods A total of 107 workers with LBP, with duration of pain for at least two consecutive weeks or recurrent pain of any duration during the last year, were randomized either to the intervention (n = 51) or control group (n = 56). The intervention included arrangements at the workplace, along with individual guidance provided by an occupational physiotherapist (OPT). The randomized intervention study used standard counselling and guidance by an OPT without workplace intervention as a comparison. Surveys were completed at baseline, and 6 and 12 months after baseline. Results There were no statistically significant differences between the intervention and control groups on the primary outcome measure, i.e. self-assessed work ability. We found no between-group differences in perceived health, self-assessed work productivity, number of sickness absence days and severity of back pain. However, there were significant positive within-group changes in the intervention group in the intensity of LBP, perceived health and the number of sickness absence days due to LBP. Conclusion Workplace arrangements are feasible using participatory ergonomics, but more quantitative and qualitative research is needed on its utilization and effectiveness among workers with LBP.

Cognitive behavioral therapy versus general health education for family caregivers of individuals with heart failure: a pilot randomized controlled trial

BackgroundWhile support from family caregivers is essential in the care of patients with heart failure (HF), caregiving places a considerable burden on family caregivers. We examined the preliminary effects of cognitive behavioral therapy (CBT) for caregivers of individuals with HF.MethodsIn this pilot randomized controlled trial, patients with HF and their primary family caregivers (30 dyads) were randomized into CBT (n = 15) or general health education (GHE, n = 15) groups. Caregivers received 8 weekly individual sessions of either CBT (intervention) or GHE (attention control condition). Caregivers completed questionnaires at baseline, post-intervention, and 6 months. Saliva samples collected from caregivers at baseline and post-intervention were analyzed for salivary cortisol. The cortisol awakening response (CAR) and area under the curve (AUC) were calculated using log-transformed cortisol values. We analyzed data from 26 (14 receiving CBT and 12 receiving GHE) caregivers who received at least one session of CBT or GHE (modified intention-to treat) using linear mixed models. Each model included time, study group, and time-by-study group interaction as fixed effects.ResultsPatients were older (66.94 ± 14.01 years) than caregivers (55.09 ± 15.24 years), and 54% of patients and 54% of caregivers were female. Most caregivers (58%) were spouses. A total of 14 (93%) CBT and 12 (80%) GHE participants received at least 1 session (p = .60), and 11 (73%) CBT and 11 (73%) GHE participants completed all 8 sessions (p = 1.00). There were no significant between-group differences in change for salivary cortisol or psychological outcomes. However, the CBT group had significant within-group improvements in perceived stress (p = .011), stress symptoms (p = .017), depression (p = .002), and anxiety (p = .006) from baseline to post-intervention, while the control group had no significant within-group change in the outcomes except for anxiety (p = .03). The significant improvements observed in the CBT group lasted for 6 months. No adverse effects were observed.ConclusionsIn this pilot trial, although between-group differences in change were not significant, CBT resulted in significant improvements in some psychological outcomes with no improvement in the control group. Our findings suggest the potential of the intervention to alleviate psychological distress in HF caregivers. Further examination in larger randomized trials is warranted.Trial registrationClinicalTrials.gov Identifier: NCT01937936 (Registered on 10/09/2013).

Therapeutic routine with respiratory exercises improves posture, muscle activity, and respiratory pattern of patients with neck pain: a randomized controlled trial

Neck pain and forward head posture (FHP) are typical in prolonged smartphone users and need to be targeted for treatment. We aimed to compare the effect of a routine therapeutic program with and without respiratory exercises on smartphone users with FHP and non-specific chronic neck pain (NSCNP). Sixty patients (aged 24.7 ± 2.1 years) with FHP and NSCNP were randomly assigned to the routine therapeutic program (n = 20), combined respiratory exercises with a routine therapeutic program (n = 20), or control (n = 20) groups. At baseline, there was no difference among groups at all variables. Each programme was implemented three times a week for eight weeks. Primary Outcome was pain measured by visual analogue scale (VAS), and secondary ones were forward head angle, the activity of specific muscles, and respiratory patterns, measured by photogrammetry, electromyography and manual, respectively. All outcomes were measured at baseline and eight weeks post-treatment. We used the repeated measures analysis of variance to examine the interaction between time and group, paired t-test for intragroup comparison, one-way analysis of variance for intergroup comparison, and Tukey post hoc test at a significant level 95% was used. There were significant differences in the combined group compared with the routine therapeutic group (P = 0.03) for diaphragm muscle activation, respiratory balance (P = 0.01), and the number of breaths (P = 0.02). There were significant within-group changes from baseline to post-treatment in the combined group for all outcomes above, but no changes in the therapeutic exercise routine group. Despite respiratory pattern, none of the secondary outcomes proved to be superior in the combination group compared to the routine therapeutic program in smartphone users with FHP and NSCNP. Future studies with longer follow-up assessments could strengthen these results.Trial registration: Current Controlled Trials using the IRCT website with ID number of, IRCT20200212046469N1 “Prospectively registered” at 04/03/2020.

Systematic Evaluation of the T30 Neurostimulator Treatment for Tinnitus: A Double-Blind Randomised Placebo-Controlled Trial with Open-Label Extension.

Tinnitus is often triggered by cochlear damage and has been linked with aberrant patterns of neuronal activity. Acoustic Coordinated Reset (CR®) Neuromodulation is a sound therapy hypothesised to reduce tinnitus symptoms by desynchronising pathological brain activity using a portable acoustic device (the T30 neurostimulator). We report results of a pivotal trial to test the efficacy of this intervention. This two-centre, double-blind randomised controlled trial with long-term open-label extension, was undertaken between February 2012 and February 2014 in the UK. Participants were 100 adults with tinnitus as a primary complaint, recruited through hearing clinics and media advertisements. Intervention was the device programmed either with the proprietary sound sequence or placebo algorithm, fit by one of five trained audiologists. Minimisation software provided group allocation (1:1 randomisation), with groups matched for age, gender, hearing loss and tinnitus severity. Allocation was masked from participants and assessors during the trial. The primary measure of efficacy was change in tinnitus symptom severity between groups, measured using the Tinnitus Handicap Questionnaire at 12 weeks. Secondary outcomes were other measures of tinnitus symptom severity, health-related quality of life, and perceptual characteristics (pitch, loudness, bandwidth) at 12 weeks, and Tinnitus Handicap Questionnaire at 36 weeks (open-label extension). A statistician blinded to the allocation conducted an intention-to-treat analysis that employed linear regressions on minimisation variables, trial centre and intervention group, with multiple imputations for missing data. The study was registered on clinicaltrials.gov (NCT01541969). We screened 391 individuals and assigned interventions to 100 eligible participants. The primary outcome was not statistically significant between groups (mean group = −0.45, 95% CI −5.25 to 4.35; p = 0.85), nor were any of the secondary outcomes. Four adverse events occurred during the trial. Analysis of tinnitus symptom severity data collected across the 24-week open-label extension showed no statistically significant within-group changes after 12, 24, or 36 weeks treatment with the proprietary sound sequence. While individual participants may benefit from sound therapy, Acoustic CR® Neuromodulation did not lead to group-mean reductions on tinnitus symptom severity or other measures compared to placebo, or over time.

C-Reactive protein kinetics after cardiac surgery: A retrospective multicenter study.

Recognition of postoperative infection after cardiac surgery is challenging. Biomarkers may be very useful to recognize infection at early stage, but the literature is controversial. We conducted a retrospective study at two large University Hospitals, including adult patients undergoing cardiac surgery (excluding those with preoperative infections, cirrhotic or immunocompromised). We evaluated the kinetics of C-Reactive Protein (CRP) and White Cell Count (WCC) during the first postoperative week. Primary outcomes were CRP and WCC changes according to the development of postoperative infection. In order to evaluate the influence of cardiopulmonary bypass on biomarker kinetics, we also studied CRP and WCC changes in patients without postoperative infection and undergoing on- vs off-pump coronary-artery bypass grafting. Among 429 included, 45 patients (10.5%) had evidence of postoperative infection. Patients with postoperative infection had higher CRP and WCC values than those without infection, with between-groups difference becoming significant from postoperative day 2 for CRP (120.6 ± 3.6 vs. 134.6 ± 7.9, P &lt; 0.01), and from postoperative day 3 for WCC (10.5 ± 0.5 vs. 9.9 ± 0.2, P = 0.02). Over the postoperative period, CRP and WCC showed significant within-group changes regardless of development of postoperative infection (P &lt; 0.001 for both). We found no differences in CRP and WCC kinetics between patients undergoing on- vs off-pump procedure. During the first week after cardiac surgery, CRP increases one day earlier than WCC in patients developing postoperative infections, with such difference becoming significant on the second postoperative day. In not infected patients, use of cardiopulmonary bypass does not influence CRP and WCC kinetics.

Nighttime compression supports improved self-management of breast cancer-related lymphedema: A multicenter randomized controlled trial.

Lymphedema is a prevalent long-term effect of breast cancer treatment associated with reduced quality of life. This study examined the efficacy of nighttime compression as a self-management strategy for women with chronic breast cancer-related lymphedema. Th authors conducted a parallel 3-arm, multicenter, randomized trial. Women were recruited from 3 centers in Canada and randomized to group 1 (daytime compression garment alone [standard care]), group 2 (daytime compression garment plus nighttime compression bandaging), or group 3 (daytime compression garment plus the use of a nighttime compression system garment). The primary outcome was the change in excess arm volume from the baseline to 12weeks. Participants from all groups used a nighttime compression system garment from weeks 13 to 24. One hundred twenty women were enrolled, 118 completed the randomized trial, and 114 completed the 24-week follow-up. The rates of adherence to nighttime compression were 95%±15% and 96%±11% in the compression bandaging and nighttime compression system groups, respectively. After the intervention, the addition of nighttime compression was found to be superior to standard care for both absolute milliliter reductions (P=.006) and percentage reductions (P=.002) in excess arm lymphedema volume. Significant within-group changes were seen for quality of life across all groups; however, no between-group differences were found (P>.05). The trial demonstrated a significant improvement in arm lymphedema volume from the addition of nighttime compression whether through the application of compression bandaging or through the use of a nighttime compression system garment. Lymphedema is swelling that occurs in the arm on the side of the surgery for breast cancer. Lymphedema occurs in approximately 21% of women. Lymphedema tends to worsen over time and can result in recurrent infections in the arm, functional impairment, and pain. Currently, treatment consists of intensive treatments to reduce the swelling followed by regular use of a compression sleeve during the day. This study examined and found a benefit from the addition of nighttime compression (whether through self-applied compression bandaging or through the use of a nighttime compression system garment) to the use of a daytime compression sleeve.

6.14 Randomized, Placebo-Controlled Trial With Open-Label Extension of Intranasal Oxytocin for Autism Spectrum Disorder

The neuropeptide oxytocin (OXT) plays an important role in human social behaviors. There is growing interest in the use of OXT for mental health conditions characterized by social impairment. Studies of adult populations with autism spectrum disorder (ASD) have shown promising responses in social cognition, quality of life, and repetitive behaviors. To date, few studies have examined the safety and tolerability of the sustained use of OXT in a pediatric population with ASD. None have comprehensively elicited adverse events, monitored cardiac function, or collected routine blood chemistries in a systematic way to evaluate the safety of intranasal OXT. In order to investigate the safety, tolerability, and potential efficacy of sustained, daily administration of OXT in children with ASD, we conducted a randomized, double-blind, placebo-controlled crossover pilot study in 25 youths aged 3 to 17 years. Intranasal administration of flexibly dosed oxytocin or placebo was provided for 8 weeks; then an additional 8 weeks of open-label oxytocin was given to all participants. All screened participants (n = 27) were recruited through the University of North Carolina at Chapel Hill. OXT treatment was well tolerated with the exception of a single subject. One in 12 subjects randomized to OXT discontinued during blind treatment, and 2 in 24 discontinued during open treatment. Adverse events were comparable between the oxytocin and placebo groups. All safety assessments including EEG and blood chemistry revealed no clinically significant differences between OXT and placebo. Secondary efficacy assessments indicated that significant within-group changes were observed after 8 weeks on the Aberrant Behavior Checklist (ABC)-Social Withdrawal, ABC-Irritability, and ABC-Stereotypy subscales (3 variables: all p < 0.05) in the OXT group. Findings in this study must be interpreted in the context of several limitations. Most prominent are the small sample size and multiple assessments. The primary goal of this study was to evaluate the safety and tolerability of a treatment that may be used for months if not years in a pediatric population. Our small pilot sample would likely miss uncommon but serious adverse events. Future studies must be powered and of sufficient duration to explore the long-term safety and tolerability of OXT.