Implementation of a Mindful Walking Intervention in Breast Cancer Patients After Their Primary Oncologic Treatment: Results of a Qualitative Study Within a Randomized Controlled Trial.

BACKGROUND: Breast cancer survivors often suffer from diagnosis- and therapy-related long-term side effects, such as cancer related fatigue, restricted stress resilience and quality of life. Walking as a physical activity and mindfulness practice have been shown to be helpful in studies. The aim of this study was to compare the individual experiences and subjectively perceived effects of walking in combination with mindfulness practice with moderate walking alone in breast cancer patients. This paper focuses on the qualitative results of a mixed-methods pilot study. METHODS: Breast cancer patients who had finished their primary oncologic treatment at least 6 months ago were randomized to an 8-week group intervention program of either mindful walking or moderate walking. Within the qualitative study part, semi-structured focus group interviews (2 interviews per study arm) were conducted and analyzed using a qualitative content analysis approach. Audio recorded interviews were transcribed verbatim and pseudonymized. The subsequent data analysis was performed by using MAXQDA®. RESULTS: A total of 51 women (mean age 55.8 [SD 10.9] years) were included in the RCT, among these 20 (mean age 56.7 [SD 12.0] years) participated in the focus group interviews (n = 11 patients of the mindful walking group; n = 9 patients of the walking group). Breast cancer patients in both groups described different effects in the complex areas of self-efficacy, coping, body awareness and self-reflection. While mindful walking primarily promoted body awareness and inner strength by mindfulness in breast cancer patients, moderate walking promoted self-efficacy by a confidence of their body and an easily integrated and accepted way of physical activity. CONCLUSIONS: Study interventions and the study setting triggered processes and reflections on one's own health and situation. However, mindful walking and moderate walking seem to address different resources. This important knowledge may help oncologists and other therapists to assess what type of interventions can best meet the needs and requirements of individual patients. TRIAL REGISTRATION: DKRS00011521; prospectively registered 21.12.2016; https://drks.de/search/de/trial/DRKS00011521.

Multicomponent Intervention on Improving the Cognitive Ability of Older Adults with Mild Cognitive Impairment: A Pilot Randomized Controlled Trial.

This pilot randomized controlled trial aimed to evaluate the feasibility and potential outcomes of an innovative 16-session multicomponent intervention model to improve cognitive abilities in older adults with mild cognitive impairment (MCI) by promoting healthy lifestyle, cognitive skills, tai chi and mindfulness practices. This study was a multicentre, randomized controlled, two-arm, parallel-group, unblinded trial in Hong Kong. 57 Chinese older adults with MCI recruited from three local elderly centers were randomly assigned to either the control or intervention group. The study results support the feasibility and efficacy of the multicomponent intervention, and recommend future larger-scale randomized control trials.

Development and Validation of a Scoring Rubric for Editorial Evaluation of Peer-review Quality: A Pilot Study.

Introduction: Despite the importance of peer review to publications, there is no generally accepted approach for editorial evaluation of a peer review's value to a journal editor's decision-making. The graduate medical education editors of the Western Journal of Emergency Medicine Special Issue in Educational Research & Practice (Special Issue) developed and studied the holistic editor's scoring rubric (HESR) with the objective of assessing the quality of a review and an emphasis on the degree to which it informs a holistic appreciation for the submission under consideration. Methods: Using peer-review guidelines from several journals, the Special Issue's editors formulated the rubric as descriptions of peer reviews of varying degree of quality from the ideal to the unacceptable. Once a review was assessed by each editor using the rubric, the score was submitted to a third party for blinding purposes. We compared the performance of the new rubric to a previously used semantic differential scale instrument. Kane's validity framework guided the evaluation of the new scoring rubric around three basic assumptions: improved distribution of scores; relative consistency rather than absolute inter-rater reliability across editors; and statistical evidence that editors valued peer reviews that contributed most to their decision-making. Results: Ninety peer reviews were the subject of this study, all were assessed by two editors. Compared to the highly skewed distribution of the prior rating scale, the distribution of the new scoring rubric was bell shaped and demonstrated full use of the rubric scale. Absolute agreement between editors was low to moderate, while relative consistency between editor's rubric ratings was high. Finally, we showed that recommendations of higher rated peer reviews were more likely to concur with the editor's formal decision. Conclusion: Early evidence regarding the HESR supports the use of this instrument in determining the quality of peer reviews as well as its relative importance in informing editorial decision-making.

Pilot study of musculoskeletal pain in ophthalmologists following participation in a fifteen-minute online Iyengar yoga program.

Purpose: To evaluate the prevalence of musculoskeletal (MSK) complaints in ophthalmologists and to assess whether participation in an online Iyengar yoga video program improves the baseline pain scores and awareness of proper posture in the clinic and operating room. Methods: Ophthalmologists were recruited from online professional forums for this nonrandomized, prospective study. A pre-intervention survey, including demographics, office and procedure volumes, wellness activities, and baseline MSK pain scores, was completed. A fifteen-minute instructional video focusing on simple yoga poses for the neck, shoulder, and lower back created by one of the authors, who is both an ophthalmologist and a certified Iyengar yoga teacher, was provided to participants to complete three times weekly for a total of 4 weeks. A post-intervention survey collecting MSK pain scores and information about ergonomics and compliance was completed. Results: Fifty ophthalmologists completed the pre-intervention survey, of whom 49 (98%) reported at least 1 episode of MSK discomfort in the preceding year. Of those, discomfort was cervical in 36 (72%), in the shoulder(s) in 15 (29%), thoracic spinal in 23 (46%), lumbar spinal in 23 (46%), and centered in the wrist, hand, or finger in 22 (44%). Of the 50 ophthalmologists, 22 submitted the post-intervention surveys. The post-intervention pain scores were decreased compared to baseline for cervical spine (P < 0.01), shoulder (P < 0.01), thoracic spine (P < 0.01), lumbar spine (P < 0.01) and wrist, hand, or finger (P < 0.01). 20 respondents (91%) reported improved awareness of their posture in the clinic and operating room, and 19 (86%) felt that this awareness would decrease their MSK symptoms. Conclusions: Among our small group of survey respondents, a fifteen-minute Iyengar yoga video program specifically designed for ophthalmologists reduced MSK pain and improving awareness of proper ergonomics for practicing ophthalmologists.

Identifying Gut Microbiome Features that Predict Responsiveness Toward a Prebiotic Capable of Increasing Calcium Absorption: A Pilot Study.

Previously, we demonstrated that prebiotics may provide a complementary strategy for increasing calcium (Ca) absorption in adolescents which may improve long-term bone health. However, not all children responded to prebiotic intervention. We determine if certain baseline characteristics of gut microbiome composition predict prebiotic responsiveness. In this secondary analysis, we compared differences in relative microbiota taxa abundance between responders (greater than or equal to 3% increase in Ca absorption) and non-responders (less than 3% increase). Dual stable isotope methodologies were used to assess fractional Ca absorption at the end of crossover treatments with placebo, 10, and 20 g/day of soluble corn fiber (SCF). Microbial DNA was obtained from stool samples collected before and after each intervention. Sequencing of the 16S rRNA gene was used to taxonomically characterize the gut microbiome. Machine learning techniques were used to build a predictive model for identifying responders based on baseline relative taxa abundances. Model output was used to infer which features contributed most to prediction accuracy. We identified 19 microbial features out of the 221 observed that predicted responsiveness with 96.0% average accuracy. The results suggest a simplified prescreening can be performed to determine if a subject's bone health may benefit from a prebiotic. Additionally, the findings provide insight and prompt further investigation into the metabolic and genetic underpinnings affecting calcium absorption during pubertal bone development.

Health Qigong Mawangdui Guidance can improve pelvic floor muscle function and quality of life in females with stress urinary incontinence: A randomized controlled trial pilot study.

BACKGROUND: Urinary incontinence (UI) is a great problem of public health, especially for women's quality of life. UI afflicts at least 21.6% of the global population, and more than half of the UI is related to female stress urinary incontinence (SUI). Mawangdui Guidance plays an important role in preventing diseases and maintaining health. METHODS: Sixty female patients with SUI were randomly divided into a control group (n = 30) and an experimental group (n = 30). Patients in both groups were treated with basic rehabilitation therapy under the guidance of rehabilitation therapists who were trained in Mawangdui Guidance, based on the former, the experimental group was taught to exercise Mawangdui Guidance(including selected movements: "Qishi," "Longdeng," "Chishi," and "Yinyao"), while the control group performed Kegel exercise with a procedure of 20 min, six times per week for 6 weeks. The function was mainly evaluated by the 1 h pad-test, incontinence quality of life questionnaire (I-QOL), and international consultation on incontinence questionnaire urinary incontinence short form (ICI-Q-SF). In addition, evaluation of pelvic floor muscle function was also included in our assessment. RESULTS: The leakage of urine in the 1 h pad-test was significantly decreased in both two groups after treatment (P < .05), and the urine leakage in the experimental group was significantly less than that in the control group (P < .05). The muscle strength of type I and II muscle fibers of the pelvic floor, intravaginal pressure, and I-QOL score in both two groups were increased after treatment; moreover, the experimental group was more significant than the control group (P <.05). The fatigue degree of type I and type II muscle fibers of the pelvic floor, and the ICI-Q-SF score in both groups were significantly improved after treatment (P < .05); however, there were no differences between these two groups. The total effective rate of the experimental group was 90.00%, and 76.67% in the control group (P <.05). CONCLUSION: Mawangdui Guidance can effectively improve the function of pelvic floor muscle, improve the ability of urine storage and control, and alleviate the symptoms of female patients with SUI. However, the international research on Mawangdui Guidance is very limited, and more in-depth research is needed.

Effects of Reishimmune-S, a Fungal Immunomodulatory Peptide Supplement, on the Quality of Life and Circulating Natural Killer Cell Profiles of Patients With Early Breast Cancer Receiving Adjuvant Endocrine Therapy.

OBJECTIVES: To evaluate the effects of Reishimmune-S, a fungal immunomodulatory peptide, on the quality of life (QoL) and natural killer (NK) cell subpopulations in patients receiving adjuvant endocrine therapy (ET) for breast cancer (BC). METHODS: Patients who received adjuvant ET for stage I-III hormone receptor-positive BC without active infection were enrolled in this prospective pilot study. Reishimmune-S was administered sublingually daily for 6 months. QoL scores, circulating immune cell levels, including lymphocyte/NK cell subpopulations, and plasma levels of interleukin (IL)-6 and tumor necrosis factor (TNF)-α were measured at baseline and every 4 weeks. Data were analyzed using linear mixed-effect regression models. RESULTS: Nineteen participants were included in the analyses. One patient with underlying asthma did not complete the study owing to the occurrence of skin rashes 15 days after the initiation of Reishimmune-S. No other adverse events were reported. Reishimmune-S supplementation significantly improved the cognitive function at 3 months and significantly decreased the fatigue and insomnia levels at 3 and 6 months, respectively. There was no significant change in the global health/QoL score between baseline and week 4 of treatment. The proportion of CD19+ lymphocytes was significantly higher at 3 and 6 months, and that of NKG2A+ and NKp30+ NK cells was significantly lower at 6 months than at baseline. In addition, fatigue positively correlated with the proportion of NKp30+ NK cells (ß ± standard error: 24.48 ± 8.75, P = .007 in the mixed-effect model). CONCLUSIONS: Short-term supplementation with Reishimmune-S affected the circulating immune cell composition and exerted positive effects on cognitive function, fatigue, and insomnia in patients with BC undergoing adjuvant ET, providing a potential approach for the management of treatment-related adverse reactions in this patient population.

Working mechanisms of imagery rescripting (ImRs) in adult patients with childhood-related PTSD: a pilot study.

Background: Imagery rescripting (ImRs) has shown to be an effective treatment for posttraumatic stress disorders (PTSD) resulting from childhood-related trauma. The current theory is that the change of meaning of the trauma memory is central to the treatment. Several authors have suggested that the expression of needs, feelings and actions may act as potential healing factors, but little specific research aimed at (in)validating this hypothesis has been done so far.Objective: In this study we investigated to what extent the expression of inhibited action tendencies and the fulfilling of needs lead to the reduction of PTSD symptoms in clients with early childhood trauma.Method: Recordings of 249 therapy sessions of 24 ImRs treatments were rated with an observation instrument developed for this purpose, after which the scores were related to pre and posttreatment symptoms, assessed with the Impact of Events Scale-Revised (IES-R).Results: Scores on the IES-R decreased from pretreatment to posttreatment. The two subscales of the NATS (At-scale and N-scale)significantly predicted the posttreatment scores on the IES-R after controlling for the influence of pretreatment IES-R scores: the better the expression of inhibited action tendencies and the better the fulfilling of needs, the lower the symptoms after treatment.Conclusions: This pilot study on the underlying mechanisms of ImRs in PTSD treatment has shown that the expression of action tendencies and fulfilling basic needs during ImRs are associated with a decrease in PTSD symptoms after treatment, and that actions and basic needs cannot be viewed separately. Follow-up research could focus on which of the six domains of the Needs and Action tendencies Scale (NATS) has the greatest effect on the reduction of PTSD symptoms. With this information we can further improve the ImRs protocol.

The pilot study of working mechanisms of imaginary rescripting shows that the NATS is a reliable research tool for observing expressed action tendencies and fulfilled needs.The better the action tendencies are expressed during treatment and the better the needs are fulfilled, the lower posttreatment symptoms.It seems useful if practitioners are specifically trained during the ImRs training in performing actions that lead to the fulfilment of basic needs.

Machine learning-based detection of acute psychosocial stress from body posture and movements.

Investigating acute stress responses is crucial to understanding the underlying mechanisms of stress. Current stress assessment methods include self-reports that can be biased and biomarkers that are often based on complex laboratory procedures. A promising additional modality for stress assessment might be the observation of body movements, which are affected by negative emotions and threatening situations. In this paper, we investigated the relationship between acute psychosocial stress induction and body posture and movements. We collected motion data from N = 59 individuals over two studies (Pilot Study: N = 20, Main Study: N = 39) using inertial measurement unit (IMU)-based motion capture suits. In both studies, individuals underwent the Trier Social Stress Test (TSST) and a stress-free control condition (friendly-TSST; f-TSST) in randomized order. Our results show that acute stress induction leads to a reproducible freezing behavior, characterized by less overall motion as well as more and longer periods of no movement. Based on these data, we trained machine learning pipelines to detect acute stress solely from movement information, achieving an accuracy of 75.0 ± 17.7 % (Pilot Study) and 73.4 ± 7.7 % (Main Study). This, for the first time, suggests that body posture and movements can be used to detect whether individuals are exposed to acute psychosocial stress. While more studies are needed to further validate our approach, we are convinced that motion information can be a valuable extension to the existing biomarkers and can help to obtain a more holistic picture of the human stress response. Our work is the first to systematically explore the use of full-body body posture and movement to gain novel insights into the human stress response and its effects on the body and mind.

Radical resection and hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of high risk recurrent retroperitoneal sarcoma-A pilot study in a tertiary Asian centre.

BACKGROUND: Peritoneal sarcomatosis (PS) is a difficult entity to treat with limited options and guarded prognosis. We aimed to determine if the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) could offer superior local recurrence-free survival in patients with retroperitoneal sarcoma at high risk of developing PS as opposed to extended resection alone. METHODS: This is a single arm, phase II intervention study where all patients with recurrent localized retroperitoneal sarcoma considered at high risk of developing PS were considered for enrolment (ClinicalTrials.gov identifier: NCT03792867). Upon enrolment, patients underwent vigorous preoperative testing to ensure fitness for the procedure. During surgery, patients underwent extended resection and HIPEC with doxorubicin. Patients were followed-up every 2 weeks (± 10 days) for the first month and subsequently every three months (± 1 month) up to a year post-surgery, and were assessed for potential chemotherapy toxicity and post-treatment complications. After a year from resection and HIPEC, patients were followed-up either during routine clinic review or contacted via telephone every year (± 1 month) for 3 years. RESULTS: Six patients were recruited but one patient dropped out due to adverse and unexpected intraoperative events. The remaining patients completed the procedure uneventfully. Post-HIPEC, all patients recurred with a disease-free interval ranging from six to 24 months. Three patients died due to complications from recurrent disease whereas the remaining three patients are alive as of their last visit. The overall survival at time at reporting ranged between 22 to 56 months. CONCLUSION: The procedure is feasible with no major morbidity to patients. However, we are unable to recommend for it to be implemented as a routine procedure at this current stage due to lack of improved survival outcomes. Further multi-institutional studies may be conducted to yield better results.

An imagery rescripting based intervention in children and adolescents who endured a negative life event: A pilot study, satisfaction and feasibility survey.

BACKGROUND AND OBJECTIVES: ImRs, a technique targeting distressing mental images, has shown promise in adult psychiatric treatment. Initial research indicates positive outcomes in children, with potential for reducing mental health care burden. This pilot study examined the use of Imagery Rescripting (ImRs) as an intervention for children who have experienced negative life events. We aimed to assess short-term emotional changes, participant satisfaction, and the feasibility of a larger-scale ImRs intervention for children. METHODS: We employed a pre-posttest within-group design, and included 35 children (ages 5-18) who experienced negative life events, as well as 12 coaches. ImRs targeted distressing images related to negative events. Measurement tools included Visual Analogue Scales for distress and emotions, along with satisfaction surveys for both children and coaches. The feasibility of a larger-scale study was also explored through a coach questionnaire. RESULTS: We found significant short-term improvements for all emotional states, with large effects for anxiety, sadness, and happiness, and a moderate effect for anger. Children reported fair levels of satisfaction with the intervention's acceptability and complexity. Coaches expressed high levels of satisfaction with the intervention as a whole and with its characteristics. Coaches were also strongly motivation for future, more in-depth research. An important limitation of this pilot study was the lack of a control group. In light of the promising results, more extensive studies with diagnostic information, multiple measures, and follow-up assessments are warranted. CONCLUSION: Altogether, imagery rescripting based interventions seem a promising venue for children who experienced negative events.

Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study.

INTRODUCTION: Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice. METHODS AND ANALYSIS: 30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring's content analysis. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23-11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.

A randomized double-blind pilot study to evaluate the efficacy, safety, and tolerability of intravenous iron versus oral iron for the treatment of restless legs syndrome in patients with iron deficiency anemia.

Restless legs syndrome (RLS) is a neurological disorder that can have a profound effect on sleep and quality of life. Idiopathic RLS is associated with brain iron insufficiency despite normal peripheral iron stores. There is, however, a five- to six-fold increase in prevalence of RLS in patients with iron deficiency anemia (IDA). Several open-label trials have demonstrated symptomatic improvement in RLS following treatment of IDA using oral or intravenous iron supplementation. To date, there have been no randomized double-blind controlled trials of intravenous iron compared with oral iron for the treatment of RLS patients with IDA. In the current study, oral ferrous sulfate and ferumoxytol were compared for efficacy and speed of response for treatment of RLS occurring in patients with IDA. The planned recruitment for this study was 70 patients with RLS and IDA, to be randomly assigned 1:1 to oral or intravenous iron, using double-blind, double-dummy procedures. At Week 6, the primary outcomes of Clinical Global Impression-Improvement score and change from baseline in the International Restless Legs Syndrome Study Group rating scale score were assessed. Due to challenges, performing the clinical trial during the COVID-19 pandemic, final-week data were found missing for 30 patients. As a result, in order to maintain the prespecified statistical analysis, an additional 30 patients were recruited. Both IV and oral iron were associated with a marked improvement in RLS symptoms, with no statistically significant difference between treatment groups. No serious adverse events were observed in either treatment group.

Dyadic Yoga for Head and Neck Cancer Patients Undergoing Chemoradiation and their Family Caregivers.

OBJECTIVES: Concurrent chemoradiation to treat head and neck cancer (HNC) may result in debilitating toxicities. Targeted exercise such as yoga therapy may buffer against treatment-related sequelae; thus, this pilot RCT examined the feasibility and preliminary efficacy of a yoga intervention. Because family caregivers report low caregiving efficacy and elevated levels of distress, we included them in this trial as active study participants. METHODS: HNC patients and their caregivers were randomized to a 15-session dyadic yoga program or a waitlist control (WLC) group. Prior to randomization, patients completed standard symptom (MDASI-HN) and patients and caregivers completed quality of life (SF-36) assessments. The 15-session program was delivered parallel to patients' treatment schedules. Participants were re-assessed at patients' last day of chemoradiation and again 30 days later. Patients' emergency department visits, unplanned hospital admissions and gastric feeding tube placements were recorded over the treatment course and up to 30 days later. RESULTS: With a consent rate of 76%, 37 dyads were randomized. Participants in the yoga group completed a mean of 12.5 sessions and rated the program as "beneficial." Patients in the yoga group had clinically significantly less symptom interference and HNC symptom severity and better QOL than those in the WLC group. They were also less likely to have a hospital admission (OR = 3.00), emergency department visit (OR = 2.14), and/or a feeding tube placement (OR = 1.78). CONCLUSION: Yoga therapy appears to be a feasible, acceptable, and possibly efficacious behavioral supportive care strategy for HNC patients undergoing chemoradiation. A larger efficacy trial is warranted.

Characterization of percutaneous absorption of calcium, magnesium, and potentially toxic elements in two tailored sulfurous therapeutic peloids: a comprehensive in vitro pilot study.

Pelotherapy treatments in thermal spas, which utilize peloids composed of clay minerals mixed with saltwater or mineral-medicinal water, can have various effects on spa users, ranging from therapeutic to potential adverse reactions. Despite the widespread use of peloids, comprehensive information on the penetration and permeation of essential and potentially toxic elements into deeper layers of the skin during pelotherapy is limited. Understanding the concentrations of these elements is crucial for evaluating therapeutic benefits and ensuring safety. This study investigates the in vitro availability and absorption of calcium, magnesium, and potentially toxic elements in two peloids, considering their formulation matrix. To replicate the pelotherapy methodology, an in vitro permeation experiment was conducted using a vertical diffusion chamber (Franz cells) and a biological system with human skin membranes from five Caucasian women, age range between 25 and 51 years. The experiment involved heating the peloids to 45℃. The results emphasize the possible transport properties of chemical elements in peloids, providing valuable information related to potential therapeutic efficacy and safety considerations. Despite no apparent differences between peloids' chemical composition, the method identified permeation variations among chemical elements. The methodology employed in this study adheres to the guidelines outlined by OECD for analyzing skin absorption through an in vitro approach. Furthermore, it aligns with the associated OECD guidance document for conducting skin absorption studies. The replicability of this methodology not only facilitates the analysis of peloids pre-formulation but also provides a robust means to evaluate the effectiveness of therapeutic elements during topical administration, particularly those with potential toxicity concerns.

The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomized trial.

INTRODUCTION: Restricted ankle dorsiflexion is common after lower limb injury. The aim of this pilot study was to investigate the effect of passive ankle joint mobilization and calf muscle massage on ankle dorsiflexion range of motion in adults with residual restricted dorsiflexion. The secondary aim was to assess the methodology of the pilot study to inform a larger clinical trial. METHOD: The study design was a randomized crossover trial with assessor blinding. Twenty-five healthy participants with a history of lower limb injury were included in the study. Ankle joint mobilization and calf muscle massage were applied for 5 min in a random order, one to two weeks apart. Ankle dorsiflexion was measured by using the weight-bearing lunge pre- and post-intervention (cm). Paired t-tests were used to analyze the effect of the manual therapy interventions on restricted ankles. A minimal detectable difference 95% (MMD95) was calculated. The pilot study was analyzed for suitability of inclusion criteria, blinding of assessors and the manual therapist, and the washout period. RESULTS: A significant increase in dorsiflexion was demonstrated for ankle joint mobilization (change score = 0.51 ± 0.76, p = 0.003) and calf muscle soft tissue massage (change score = 0.91 ± 1.07, p < 0.001). There was no difference in change scores between manual therapy techniques (mobilization 0.51 ± 0.76, massage 0.91 ± 1.07, p = 0.12). Evaluation of the pilot study revealed limitations to be modified in future studies. CONCLUSION: These preliminary data indicate ankle joint mobilization and calf muscle soft tissue massage had similar effects on increasing ankle dorsiflexion range of motion in ankles with residual dorsiflexion restriction.

Acute effect of scapular mobilization with associated myofascial release on butterfly performance: Randomized clinical trial.

INTRODUCTION: To evaluate the acute effect of scapular mobilization with associated myofascial release compared to scapular mobilization without myofascial release on butterfly stroke sports performance. DESIGN: Randomized clinical trial. METHOD: Pilot study that non-probabilistically convenience sampling that selected butterfly swimmers who were simply randomized into three groups to receive the standard protocol (scapular mobilization with release of the subscapularis muscle by the lateral edge of the scapula and rib cage detachment) in intervention group (IG), sham group (SG) (scapular mobilization without subscapularis muscle release and without rib cage detachment) or no intervention in control group (CG). We evaluated the stroke frequency, length, and average speed of 30 swimmers using the 8.15 Kinovea® motion analysis system. RESULTS: The findings showed that, compared to the CG and IG, the SG showed a significant reduction in mean velocity (p = 0.002; p = 0.02, respectively), stroke frequency (p = 0.002; p = 0.003, respectively), and stroke length (p = 0.01; p = 0.05, respectively). DISCUSSION: The results showed that manual therapy through scapular mobilization without associated myofascial release with detachment of the scapula from the rib cage worsened the swimming efficiency indicators even after 30 min of application of the technique. The limitations of the studies are related to the sample size, the risk of non-probabilistic contraction bias and the lack of blinding of the evaluators. Thus, the results of this study should be evaluated with caution.

The effect of lower back and lower-extremity kinesiology taping on static balance and physical function performance in people with multiple sclerosis: A pilot study.

INTRODUCTION: Multiple sclerosis (MS) can lead to numerous deficits in body functions, including balance and mobility impairment. This study examined the effect of lower back and lower extremity kinesiology tape (KT) application on static balance and physical functioning performance in people with MS (pwMS) and compared that to a non-elastic tape. METHODS: This pilot randomized study recruited and enrolled 10 participants with MS that were allocated into two groups: kinesio (n = 6) and non-elastic (n = 4) tape. Participants were assessed with and without the respective tape on static balance with eyes open and closed and various physical function tests. RESULTS: Effect sizes for the Kinesio tape intervention were found to be small, while effect sizes for the sham tape/place condition varied from small to high. For both groups, the tendency was to reduce or maintain performance on the tests comparing tape and no tape. A subsequent, mixed-factor ANOVA revealed no significant difference between KT or sham tape/placebo. CONCLUSION: Our findings suggest that KT applied on lower back and lower extremity muscles does not seem to improve static balance and physical function performance in pwMS.

Translation from Preclinical Research to Clinical Trials: Brain-Gut Photobiomodulation Therapy for Alzheimer's Disease.

Recently, novel non-pharmacological interventions, such as photobiomodulation (PBM) therapy, have shown promise for the treatment of Alzheimer's disease (AD). This article outlines the translation from the preclinical to clinical stages of an innovative brain-gut PBM therapy in a mouse model of AD, a pilot clinical trial involving mild-to-moderate AD patients, and a continuing pivotal clinical trial with a similar patient population. In a mouse model of AD (Aß25-35), daily application of brain-gut PBM therapy to both the head and the abdomen produced a neuroprotective effect against the neurotoxic effects of an Aß25-35 peptide injection by normalizing all the modified behavioral and biochemical parameters. The pilot clinical trial to evaluate brain-gut PBM therapy demonstrated the tolerability and feasibility of the novel PBM-based treatment for mild-to-moderate AD patients. Compared to the sham patients, the PBM-treated patients had lower Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) comprehension sub-scores, higher forward verbal spans, and lower Trail Making Test (TMT) Part B (TMT-B) execution times, which suggest an improvement in cognitive functions. This pilot study provided important information for the design of a novel pivotal clinical trial, currently in progress, to assess the efficacy of brain-gut PBM therapy in a larger sample of AD patients. This pivotal clinical trial could demonstrate that brain-gut PBM therapy is a safe, well-tolerated, and efficient disease-modifying treatment for mild-to-moderate AD patients and that it has medical and economic benefits.

Randomized crossover clinical trial of a Mindfulness-based intervention for nurse leaders: A pilot study.

OBJECTIVE: to analyze the effects of a Mindfulness-based intervention on nurse leaders' emotional intelligence and resilience. METHOD: a pilot study of a randomized crossover clinical trial. The sample (n=32) was randomized into Group A (n=18) and Group B (n=14) and evaluated at the pre-test, post-test and follow-up moments. The outcomes were assessed using the Emotional Intelligence Measure, the Connor-Davidson Resilience Questionnaire and the Five Facet Mindfulness Questionnaire, and analyzed using Generalized Linear Mixed Models. RESULTS: a total of 32 nurses with a mean age of 42.6 years old were evaluated. The analyses showed significant interactions between the effects of the group x moment factors on the Self-motivation (p=0.005), Sociability (p<0.001), Self-control (p=0.013), and Total (p=0.002) emotional intelligence skill scores; as well as on the Observe (p=0.042), Describe (p=0.008), Non-judgment (p<0.001), Act with awareness (p=0.004) and Total (p<0.001) mindfulness facets. Post-test: there was a statistically significant increase in the Sociability (p=0.009) and Self-control (p=0.015) emotional intelligence skills; as well as in the Non-judgment (p=0.022) and Total (p=0.002) mindfulness facets. Follow-up: a significant increase was observed in the Non-judgment (p=0.024) and Total (p=0.026) mindfulness facets. The "resilience" variable did not present statistical significance in the "group x moment" factor, both in the post-test and during follow-up. CONCLUSION: the Mindfulness-based intervention used proved to be effective in increasing nurse leaders' emotional intelligence and dispositional mindfulness skills. Brazilian Registry of Clinical Trials (RBR-3c62gy), registered on March 4 th , 2020, updated on September 16 th , 2022. BACKGROUND: (1) Unpublished study of a Mindfulness-based intervention with nurse leaders. BACKGROUND: (2) Positive effect on the participants' emotional intelligence and mindfulness. BACKGROUND: (3) Advances in knowledge about emotional intelligence and leadership resilience. BACKGROUND: (4) It encourages the implementation of sensitive and innovative health strategies.