Weeks Of Intervention Research Articles

Evaluation of the effectiveness and safety of Korean red ginseng extract as immune-enhancer in Vietnamese adults: A randomized placebo-controlled trial

Purpose: To investigate the safety and immune-enhancing effect of Korean red ginseng (KRG) extract in Vietnamese adults. Methods: Participants in this randomized, placebo-controlled double-blinded study were administered either 960 mg of KRG extract (n = 51) or placebo capsules (n = 50) for 12 weeks at Hanoi Medical University, Vietnam. The KRG extract was standardized to contain 5.27 mg of 3 ginsenosides (Rg1, Rb1, and Rg3) per gram. Blood samples for assessment of treatment effectiveness were collected from the subjects on days 21 and 84. Immune cytokines were quantified using enzyme-linked immunosorbent assay (ELISA). Blood samples for safety assessment, hematological and biochemical variables, and urinalysis were performed at the beginning and end of the intervention (days 21 and 84, respectively). Results: The KRG group showed a significant increase in lymph T cell % at the end of the 12-week intervention (p < 0.001). There were significant decreases in numbers of white blood cells (WBC) and natural killer (NK) cells in both groups. However, there were no significant differences in populations of WBC and NK cells between the 2 groups. Serum concentrations of cytokines, i.e., TNF-α, β, γ; IFN- α, γ; IL-1β and 4β were decreased in the KRG group when compared to baseline values. There were no probable or definite adverse events (AEs) related to KRG. A total of 9 participants (4 in KRG group and 5 in placebo group) tested positive for COVID-19 during the trial. Conclusion: The KRG extract-induced increase in population of T-cells and reductions in cytokine levels following a 12-week exposure may be beneficial for COVID-19 patients.

Efficacy of Vagal nerve stimulation on anxiety among elderly retired teachers during COVID-19 pandemic.

Excessive fear, worry and behavioral disturbances define anxiety, with particular significance attributed to vagal nerve, a crucial transmitter of information to the brain regions governing anxiety. Highlighting the importance of vagal nerve, transcutaneous auricular vagal nerve stimulation (TaVNS) emerges as a tolerable and safe technique. The success of non-invasive vagal nerve stimulation in alleviating anxiety underscores the pivotal role of the vagal nerve. The purpose of this study was to assess the effectiveness of physiotherapy interventions in mitigating anxiety among retired teachers during the COVID-19 pandemic, emphasizing the relevance of targeting the vagal nerve for improved mental well-being. 60 retired teachers diagnosed with anxiety were chosen through random allocation. Participants were divided into two groups: Group A (Experimental group) received transcutaneous auricular vagal nerve stimulation (TaVNS), and Group B (Control group) underwent the Jacobson relaxation technique. Intervention period spanned 4 weeks, with four sessions per week, lasting 30 minutes. The outcome measures included Generalized Anxiety Disorder-7 (GAD-7) questionnaire and salivary cortisol levels. Following the 4-week intervention, both groups exhibited a significant reduction in Generalized Anxiety Disorder-7 (GAD-7) scores and salivary cortisol levels (P < 0.001). Notably, Group A demonstrated a significantly higher effectiveness rate compared to Group B. The study concludes that transcutaneous auricular vagal nerve stimulation (TaVNS) is effective in reducing anxiety among retired teachers. Transcutaneous auricular vagal nerve stimulation (TaVNS) proves to be a powerful and effective intervention in alleviating anxiety among retired teachers, emphasizing its potential significance in enhancing mental well-being.

Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial.

There is a critical need for evidence-based and manualized interventions targeting water competency including swim and water safety skills tailored to meet the needs of children on the autism spectrum, a group that is at a high risk of drowning. This study examined the efficacy of AquOTic-a 10-week occupational therapy-based aquatic intervention to improve water competency among children on the autism spectrum. A total of 37 children on the autism spectrum (ages 5-9 years) were randomized to a waitlist control group (n = 24) or AquOTic intervention group (n = 37; 28 males). Blinded assessors administered the standardized Water Orientation Test-Alyn (WOTA) 1 and 2 and a Swim Skills Checklist to all participants pre- and post-AquOTic/control. Repeated measures mixed effects models were used to examine intervention effects. Average WOTA 1 scores increased significantly after participants received AquOTic (Δ = 5.7; 95% CI: 3.7-7.8; p < 0.001), and average WOTA 2 scores increased significantly after participants received AquOTic (Δ = 9.0; 95% CI: 5.7-12.3; p < 0.001). Average swim skills increased significantly after participants received AquOTic (Δ = 7.6; 95% CI: 5.3, 10.0; p < 0.001). Our results highlight the efficacy of AquOTic to improve water competency among children on the autism spectrum. Further research is needed to examine long-term effects, dosage requirements to achieve water competency, and the impact of aquatic therapy on other health outcomes. clinicaltrials.gov, NCT05524753.

Running is acceptable and efficacious in adults with non-specific chronic low back pain: the ASTEROID randomised controlled trial

ObjectivesRunning is one of the most accessible forms of exercise, yet its suitability for adults with chronic low back pain (LBP) is unknown. This study assessed the efficacy and acceptability...

ChatGPT as a psychotherapist for anxiety disorders: An empirical study with anxiety patients.

Purpose: this study aims to investigate the role of ChatGPT as a psychotherapist for anxiety disorders, examining its effectiveness, acceptability, and potential benefits among individuals with anxiety disorders. Methods: a quasi-experimental design was adopted, involving a 4-week intervention where participants used ChatGPT as a therapeutic tool. The study included outpatients aged above 18 years from public hospitals in Saudi Arabia. A total of 399 participants completed a survey questionnaire that focused on their experiences with AI-based psychotherapy (six items), perceptions of ChatGPT (four items), and its role in different therapy modalities for anxiety management (seven items). Measures were taken to ensure the validity and reliability of responses by using Cronbach's alpha reliability testing (> 0.7), including the use of a translated and verified questionnaire. Results: majority received prior therapy (89.6%), reporting severe anxiety symptoms (36.1%). ChatGPT was widely used and perceived as accurate by 91.2% of users. Concerns included privacy (67.2%) and ethics (64.9%). Statistically significant differences (p < .05) in perceptions of ChatGPT for anxiety disorders were observed. While urban residents generally rated ChatGPT more positively, females consistently reported higher levels of trustworthiness, effectiveness, and coherence in guidance compared to males. Conclusion: ChatGPT has the potential to complement traditional psychotherapeutic approaches and enhance access to quality mental health care.

12424 A Feasibility Trial Of A Co-created Digital Self-management Programme For Adults With Polycystic Ovary Syndrome (Hope PCOS)

Abstract Disclosure: C.A. Percy: None. A. Turner: None. L. Aphramor: None. D. Broom: None. C. Clark: None. F. Martin: None. P. Wark: None. Introduction: Polycystic ovary syndrome (PCOS) has significant impact on depression, anxiety, psychological wellbeing and health-related quality of life. We co-created a theory-led, evidence-based, 6-week, digital self-management and positive wellbeing intervention (Hope PCOS), delivered to UK adults. We tested the intervention’s potential to improve mental health and wellbeing outcomes and its acceptability and usability for adults living with PCOS. Methods: This was a mixed methods feasibility randomised controlled trial conducted online, with a pre-post, waitlist-controlled design. Primary outcomes were recruitment, completion (≥ 3 intervention sessions) and follow-up rates. At baseline, participants reported demographic information, PCOS symptoms, depression (Patient Health Questionnaire (PHQ-9)), anxiety ((Generalised Anxiety Disorder Assessment (GAD-7)), polycystic ovary syndrome health-related quality of life (PCOSQ-50), psychological wellbeing (Warwick-Edinburgh Mental Wellbeing Scale, WEMWBS) and self-efficacy (Self-Efficacy to Manage Chronic Disease Scale (SEMCD6)) before randomisation to an intervention group (IG) receiving the intervention immediately or a waitlist control group (CG) receiving the intervention 12 weeks later. PHQ-9, GAD-7, PCOSQ-50, WEMWBS and SEMDC6 were reassessed at 6 and 12 weeks. IG participants reported the usability of the digital intervention (system usability scale (SUS)) and acceptability via qualitative exit interviews. Results: Of 131 eligible, consented participants, 83% (N=109, age M=37.1, SD=8.6 years) completed baseline measures and were randomised to the IG (n=54) or the CG (n=55). Baseline clinical caseness was high for depression (n=77, 70.6%) and anxiety (n=78, 71.6 %). Twenty-one participants (39%) in the IG completed ≥3 intervention sessions. At 6-week follow-up, completion of secondary outcomes was n=32 (59%) for IG and n= 38 (69%) for CG; at 12 weeks, n=31 (57%) for IG and n= 38 (69%) for CG. Twelve IG participants took part in the exit interviews. Exploratory descriptive statistics suggest there were greater improvements in depression, anxiety, psychological wellbeing, self-efficacy and quality of life for the intervention group completers compared to the waitlist control group. SUS data and thematic analysis suggest the intervention was usable, acceptable, relevant and interesting. Participants reported experiences including feeling seen and valued, having the difficulties of lifestyle change acknowledged, and learning valuable lessons, particularly how to monitor and manage emotions, prioritise self-care and complete personal goals. Conclusions: This novel intervention was rated as usable and acceptable, with potential for improving mental health and wellbeing outcomes. More research is needed to identify for whom the intervention is beneficial and on implementation in practice. Presentation: 6/1/2024

8046 Milk Provision as a Potential Intervention to Improve Iodine Status in a Pregnant Cohort in Northern Ireland (NI), UK: A Randomised Controlled Trial

Abstract Disclosure: L.R. Kayes: None. K.R. Mullan: None. J.V. Woodside: None. Iodine deficiency is the leading cause of reversible mental retardation worldwide. During pregnancy there is ∼50% increase in iodine requirement for foetal neurodevelopment. The most recently studied cohorts of pregnant women across Ireland and UK consistently demonstrated mild iodine deficiency (target median urinary iodine concentration (mUIC) ≥150 µg/L). A recent study in NI has shown that women of child-bearing age provided with three litres of cow’s milk per week had improved iodine status. We wished to explore whether a similar milk intervention might improve iodine status during pregnancy. Pregnant women were recruited at their first antenatal appointment, and all were provided with the British Dietetic Association’s iodine food fact sheet. Participants were randomised to either milk intervention, (four litres/week milk delivered weekly free of charge), or no milk delivery (control group). Patients were stratified based on use of an iodine-containing multivitamin prior to randomisation. Urine was collected at recruitment, after 12-week intervention period, in the third trimester and 6-12 weeks postnatally along with an infant urine sample when possible. A total of 55 urine samples were collected from infants. A total of 118 women were recruited. Participants had a mean age of 32 years, (range 21 - 45) with a mean BMI of 27.5 kg/m2. Mean gestational age was 12 weeks (IQR 12-13 weeks). The mUIC in the whole group women was 53.2 µg/L in the first trimester. In the control group the mUIC at the first study visit (n=59) was 93.4 µg/L (22% achieving iodine sufficiency); at the second visit (n=38), the mUIC was 158.7 µg/L with 34% achieving sufficiency. In the milk group the mUIC at the first study visit (n=59) was 82.0 µg/L with 10% achieving sufficiency (no statistical significance between groups, p=0.08); at the second visit (n=43), mUIC was 154.7 µg/L with 37% achieving sufficiency (no statistical difference between groups p=0.78). The mean change in UIC between the first and second trimesters was 44.5 and 88.1 µg/L in the control and milk arms respectively (p=0.27). In this cohort, 71.4% of women reported taking an iodine-containing multivitamin in the first trimester of pregnancy with no difference between group randomised to milk intervention (p=0.95). In the infants, mUIC was 124.1 µg/L with no statistically difference in the proportion reaching iodine sufficiency according to maternal randomisation (p=0.64) or maternal use of an iodine-containing multivitamin (p=0.95). In this cohort, there was no significant improvement in mUIC in those receiving a milk intervention. Presentation: 6/1/2024

8046 Milk Provision as a Potential Intervention to Improve Iodine Status in a Pregnant Cohort in Northern Ireland (NI), UK: A Randomised Controlled Trial

Abstract Disclosure: L.R. Kayes: None. K.R. Mullan: None. J.V. Woodside: None. Iodine deficiency is the leading cause of reversible mental retardation worldwide. During pregnancy there is ∼50% increase in iodine requirement for foetal neurodevelopment. The most recently studied cohorts of pregnant women across Ireland and UK consistently demonstrated mild iodine deficiency (target median urinary iodine concentration (mUIC) ≥150 µg/L). A recent study in NI has shown that women of child-bearing age provided with three litres of cow’s milk per week had improved iodine status. We wished to explore whether a similar milk intervention might improve iodine status during pregnancy. Pregnant women were recruited at their first antenatal appointment, and all were provided with the British Dietetic Association’s iodine food fact sheet. Participants were randomised to either milk intervention, (four litres/week milk delivered weekly free of charge), or no milk delivery (control group). Patients were stratified based on use of an iodine-containing multivitamin prior to randomisation. Urine was collected at recruitment, after 12-week intervention period, in the third trimester and 6-12 weeks postnatally along with an infant urine sample when possible. A total of 55 urine samples were collected from infants. A total of 118 women were recruited. Participants had a mean age of 32 years, (range 21 - 45) with a mean BMI of 27.5 kg/m2. Mean gestational age was 12 weeks (IQR 12-13 weeks). The mUIC in the whole group women was 53.2 µg/L in the first trimester. In the control group the mUIC at the first study visit (n=59) was 93.4 µg/L (22% achieving iodine sufficiency); at the second visit (n=38), the mUIC was 158.7 µg/L with 34% achieving sufficiency. In the milk group the mUIC at the first study visit (n=59) was 82.0 µg/L with 10% achieving sufficiency (no statistical significance between groups, p=0.08); at the second visit (n=43), mUIC was 154.7 µg/L with 37% achieving sufficiency (no statistical difference between groups p=0.78). The mean change in UIC between the first and second trimesters was 44.5 and 88.1 µg/L in the control and milk arms respectively (p=0.27). In this cohort, 71.4% of women reported taking an iodine-containing multivitamin in the first trimester of pregnancy with no difference between group randomised to milk intervention (p=0.95). In the infants, mUIC was 124.1 µg/L with no statistically difference in the proportion reaching iodine sufficiency according to maternal randomisation (p=0.64) or maternal use of an iodine-containing multivitamin (p=0.95). In this cohort, there was no significant improvement in mUIC in those receiving a milk intervention. Presentation: 6/1/2024

Effects of aerobic training on cardiopulmonary fitness in patients with long COVID-19: a randomized controlled trial

BackgroundLong COVID-19 is characterized by systemic deterioration of the entire body, leading to significant physical and mental disorders. Exercise training has the potential to improve persistent symptoms and cardiopulmonary functions.MethodThis was a single-center, randomized, controlled trial. Twenty-four patients aged 18 to 75 years who had a history of SARS-CoV-2 infection and long COVID symptoms. Patients were randomly allocated in a 1:1 ratio to receive either a 4-week exercise training program or an attention control group. The training group participated in 12 supervised aerobic sessions on a cycling ergometer over 4 weeks. The outcomes were to assess the impact of a 4-week aerobic exercise on the persistent symptoms and cardiopulmonary fitness, the surrogate endpoints of COVID-19 recovery and cardiopulmonary health.ResultsAfter the 4-week intervention, significant reductions were observed in the total number of symptoms in the training group. Specifically, 67.8% of patients in the training group exhibited reduced or completely resolved symptoms, in comparison to 16.7% in the control group (P = 0.013). After adjusting for gender, significant improvements in the training group were observed for exercise time (Pgroup*time = 0.028), maximum load (Pgroup*time = 0.01), and peak VO2 (Pgroup*time = 0.001), as well as O2 pulse (Pgroup*time = 0.042) and maximum heart rate (Pgroup*time = 0.007). The score of Short Form-12, depression, anxiety, perceived stress, and insomnia did not show significant changes between groups (Pgroup*time > 0.05).ConclusionA supervised aerobic training program has the potential to alleviate persistent symptoms and improve exercise tolerance in patients with long COVID-19. Further research is necessary to confirm these effects in a large population. This intervention could be easily implemented in non-hospital settings, potentially benefiting a broader range of individuals.Trial registration numberClinicalTrials.gov NCT05961462. Registered on July 25, 2023.

The relationship between changes in pain intensity and functional disability in persistent disabling low back pain during a course of cognitive functional therapy.

Pain relief and reduced disability are both common treatment targets for persistent disabling low back pain (LBP). Cross-sectional studies show a moderate relationship between functional disability and pain intensity, but little is known about the relationship between changes in pain intensity and functional disability over multiple time points. The objective of this study was to investigate the associations between changes in functional disability and pain intensity and whether changes occurred simultaneously or differentially during a course of cognitive functional therapy for people with persistent disabling LBP. Self-reported measures of pain intensity and patient-specific functional disability were collected prior to each treatment session from 40 participants during a 12-week intervention period. Linear mixed modeling was used to assess simultaneous and lagged associations between pain intensity and functional disability over time. Sensitivity analysis using nonparametric subject-specific methods (simulation modeling analysis) was also performed. Thirty-five participants had sufficient data for analysis. Using the linear mixed-model approach, there was evidence of a moderate and simultaneous association between pain intensity and functional disability over time (regression coefficient = 0.56, 95% confidence interval: 0.44-0.68, p < 0.001). Simulation modeling analysis supported weak to mostly strong associations and supported for simultaneous change in pain and disability for the majority of participants (22 of 35, 64%). Changes in pain intensity and functional disability were moderately related across the intervention. Visual inspection of graphs indicated a very close relationship in some individuals and a decoupling of pain intensity and functional disability in others. The changes in pain intensity and functional disability seem to occur simultaneously in most individuals.

Simple Sitting Baduanjin mind-body exercise: randomized controlled trial protocol for advanced cancer patients with the fatigue-sleep disturbance symptom cluster

BackgroundAdvanced cancer patients commonly suffer from a fatigue-sleep disturbance symptom cluster. Baduanjin is considered a promising mind-body exercise for relieving the fatigue-sleep disturbance symptom cluster. However, few studies have investigated a tailored Baduanjin for advanced cancer patients. The proposed study will create an optimized Baduanjin exercise program to adapt to advanced cancer patients and evaluate the effect of a Simple Sitting Baduanjin (SSBDJ) mind-body exercise on the fatigue-sleep disturbance symptom cluster among advanced cancer patients.MethodsThe study will be a prospective, assessor-blinded, two-arm, randomized controlled trial, involving a 12-week intervention and 4-week follow-up. A total of 108 advanced cancer patients experiencing the fatigue-sleep disturbance symptom cluster will be recruited from two tertiary general hospitals in China. Participants will be randomized to an experimental group (n = 54) or a control group (n = 54). The experimental group will receive a 12-week SSBDJ intervention plus the usual care, and the control group will receive only the usual care. Outcomes including fatigue-sleep disturbance symptom cluster, fatigue, sleep disturbance, and quality of life will be measured before the intervention, at the 4th, 8th, and 12th weeks of the intervention, and 4 weeks after the intervention. The intention-to-treat principle and a generalized estimating equation will be used to analyze data.DiscussionThis study may produce a new Baduanjin exercise prescription that is user-friendly, simple to execute, more targeted, and adaptable. If proven effective, this approach may be integrated into routine cancer care to manage the fatigue-sleep disturbance symptom cluster and improve QOL in advanced cancer patients.Trial registrationChinese Clinical Trial Registry, ChiCTR-2,300,072,331. Registered on 9 June 2023.

Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial.

The first-line treatment for polycystic ovary syndrome (PCOS) is lifestyle modification. However, it is currently unknown whether digital medicine can assist patients with PCOS in maintaining a healthy lifestyle while alleviating PCOS symptoms. This study aims to evaluate the efficacy of WeChat-based digital intervention versus metformin treatment in women with PCOS and insulin resistance. A total of 80 women with PCOS and insulin resistance were recruited from an endocrinology clinic and randomly assigned to receive either a WeChat-based digital intervention (n=40, 50%) or metformin (n=40, 50%) for 12 weeks. The WeChat-based digital intervention consisted of 3 modules; a coach assisted the patients in using the intervention. The primary outcome was the change in a homeostatic model assessment for insulin resistance. At baseline and after the 12-week intervention, anthropometric parameters, menstruation frequency, sex hormone levels, metabolic factors, and body fat distribution were measured in the clinic. Furthermore, self-assessed web-based questionnaires on diet, exercise, sleep, anxiety, and depression were obtained. A total of 72 participants completed the follow-up (for a 90% follow-up rate), including 35 of 40 (88%) participants from the digital intervention group and 37 of 40 (93%) participants from the metformin group. The homeostatic model assessment for insulin resistance in the digital intervention group was significantly improved after 12 weeks of treatment with a mean change of -0.93 (95% CI -1.64 to -0.23), but no statistical difference was observed between the groups (least squares mean difference -0.20; 95% CI -0.98 to 0.58; P=.62). Both digital intervention and metformin treatment significantly improved menstruation frequency (digital intervention: P<.001; metformin: P<.001) and reduced body weight (digital intervention: P<.001; metformin: P<.001) and total fat mass (digital intervention: P<.001; metformin: P<.001). Furthermore, the digital intervention had a significant advantage over metformin in improving waist circumference (least squares mean difference -1.84; 95% CI -3.44 to -0.24; P=.03), waist-to-hip ratio (least squares mean difference -0.02; 95% CI -0.03 to 0.00; P=.03), total fat mass (least squares mean difference -1.59; 95% CI -2.88 to -0.30; P=.02), and dehydroepiandrosterone sulfate (least squares mean difference -69.73; 95% CI -129.70 to -9.75; P=.02). In terms of safety, the main adverse events were sensations of hunger in the digital intervention group (2/40, 5%) and gastrointestinal adverse events in the metformin group (12/40, 30%). Our data suggest that digital intervention is an effective treatment option for patients with PCOS, with an efficacy comparable to that of metformin, and that it can also alleviate the negative effects of medications and make it easier and more efficient to adhere to lifestyle treatments. WeChat-based digital interventions have the potential to provide a new path for the improvement and health of women with PCOS in China. ClinicalTrials.gov NCT05386706; https://clinicaltrials.gov/study/NCT05386706.

Effects of cognitive training and group psychotherapy on cognitive performance of post COVID-19 patients: an exploratory and non-randomized clinical trial.

Cognitive complaints are common signs of the Post COVID-19 (PC) condition, but the extent and type of cognitive impairment may be heterogeneous. Little is known about neuropsychological treatment options. Preliminary evidence suggests cognitive symptoms may improve with cognitive training and naturally over time. In this clinical trial, we examined whether participation in a weekly group consisting of cognitive training and group psychotherapy is feasible and would exert beneficial effects on cognitive performance in PC and whether improvements were associated with intervention group participation or represented a temporal improvement effect during syndrome progression. 15 PC patients underwent an 8-week intervention. Cognitive performance was assessed before and after each intervention group participation. A control group of 15 PC patients with subjective neurocognitive or psychiatric complaints underwent two cognitive assessments with comparable time intervals without group participation. To attribute changes to the intervention group participation, interaction effects of group participation and time were checked for significance. This is an exploratory, non-randomized, non-blinded controlled clinical trial. Within the intervention group, significant improvements were found for most cognitive measures. However, significant time x group interactions were only detected in some dimensions of verbal memory and visuo-spatial construction skills. Significant time effects were observed for attention, concentration, memory, executive functions, and processing speed. The intervention setting was feasible and rated as helpful and relevant by the patients. Our results suggest that cognitive symptoms of PC patients may improve over time. Patients affected by both neurocognitive impairments and mental disorders benefit from group psychotherapy and neurocognitive training. The present study provides evidence for a better understanding of the dynamic symptomatology of PC and might help to develop further studies addressing possible therapy designs. The main limitations of this exploratory feasibility trial are the small sample size as well as the non-randomized design due to the clinical setting.

Participant Experiences from a Randomized Controlled Trial of Heated Yoga for Depression.

Despite decades of research on yoga and depression, subjective experiences of participants in these studies have rarely been reported, and never in individuals receiving heated yoga for depression. We examined patient-reported qualitative findings from an 8-week randomized controlled trial of heated yoga for depression. Eighty medically healthy participants with moderate-to-severe depression were randomized to 8 weeks of at least twice-weekly heated yoga classes, derived from Bikram yoga, or a waitlist control. Fifty-seven participants received a clinician-administered exit interview at intervention completion/study withdrawal. The exit interview assessed: (1) how participants felt immediately following the heated yoga sessions (acute effects), (2) what they liked or found helpful about heated yoga over the 8-week intervention (positive effects), and (3) what they disliked/did not find helpful over the 8-week intervention (negative effects). Qualitative data were analyzed using thematic analysis. Acute improvements in depressive symptoms (i.e., immediately following yoga) were the most commonly reported (n = 44, 77.2%), followed by overall positive effects on depressive symptoms (i.e., over the course of the 8-week intervention; n = 33, 57.9%), including improvements in sleep (n = 10, 17.5%), energy (n = 13, 22.8%), mood (n = 18, 31.6%), motivation (n = 2, 3.5%), and concentration/decision-making (n = 5, 8.8%). Overall negative effects (i.e., over the course of the 8-week intervention) included dislike of various aspects of the intervention (n = 19, 33.3%), such as instruction (n = 7, 12.3%), difficulty (n = 7, 12.3%), repetitiveness (n = 3, 5.3%), class length (n = 2, 3.5%), and boredom (n = 7, 12.3%). Most participants reported both overall positive and negative effects (n = 37, 64.9%). Of the rest, 19 (33.3%) reported only overall positive effects, and 1 (1.8%) reported only overall negative effects. Most participant experiences were positive. Negative effects were less common and primarily involved dislike of different aspects of the heated yoga. The findings support strong acceptability and subjective improvement in depressive symptoms in depressed individuals.

The effects of AG1® supplementation on the gut microbiome of healthy adults: a randomized, double-blind, placebo-controlled clinical trial.

This study aimed to examine the effect of a commercially available multi-ingredient powder (AG1Ⓡ) on the gut microbiome and assess the impact of AG1Ⓡ on GI tolerability and other clinical safety markers in healthy men and women. Using a double-blind, randomized, two-arm, placebo-controlled, parallel design, we examined a 4-week daily supplementation regimen of AG1Ⓡ vs. placebo (PL). Fifteen men and 15 women provided stool samples for microbiome analysis, questionnaires for digestive quality of life (DQLQ), and completed visual analog scales (VAS) and Bristol stool charts to assess stool consistency and bowel frequency before and after the 4-week intervention. Participant's blood work (CBC, CMP, and lipid panel) was also assessed before and after the 4-week intervention. Alpha diversity was determined by Shannon and Chao1 index scores and evaluated by a two-way ANOVA, beta diversity in taxonomic abundances and functional pathways was visualized using partial least squares-discriminant analyses and statistically evaluated by PERMANOVA. To identify key biomarkers, specific feature differences in taxonomic relative abundance and normalized functional pathway counts were analyzed by linear discriminant analysis (LDA) effect size (LEfSe). Questionnaires, clinical safety markers, and hemodynamics were evaluated by mixed factorial ANOVAs with repeated measures. This study was registered on clinicaltrials.gov (NCT06181214). AG1Ⓡ supplementation enriched two probiotic taxa (Lactobacillus acidophilus and Bifidobacterium bifidum) that likely stem from the probiotics species that exist in the product, as well as L. lactis CH_LC01 and Acetatifactor sp900066565 ASM1486575v1 while reducing Clostridium sp000435835. Regarding community function, AG1Ⓡ showed an enrichment of two functional pathways while diminishing none. Alternatively, the PL enriched six, but diminished five functional pathways. Neither treatment negatively impacted the digestive quality of life via DQLQ, bowel frequency via VAS, or stool consistency via VAS and Bristol. However, there may have been a greater improvement in the DQLQ score (+62.5%, p = 0.058, d = 0.73) after four weeks of AG1Ⓡ supplementation compared to a reduction (-50%) in PL. Furthermore, AG1Ⓡ did not significantly alter clinical safety markers following supplementation providing evidence for its safety profile. AG1Ⓡ can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality of life.

Design of the VOILA-intervention study: A 12-week nutrition and resistance exercise intervention in metabolic or mobility compromised Dutch older adults and the response on immune-metabolic, gut and muscle health parameters

BackgroundExercise and nutrition interventions can slow ageing-induced decline in physiology. However, effects are heterogeneous and usually studied separately per outcome domain. In the VOILA study, we simultaneously study various health outcomes relevant for older adults and the inter-individual heterogeneity in response to a lifestyle intervention. MethodsVOILA is a 12-week lifestyle intervention in 3 groups of older adults (≥60 years), with compromised mobility (n=50), compromised metabolic health (n=50), or recovering from total knee replacement (TKR, n=70, of which 20 randomized to standard care only). The intervention includes high-intensity resistance exercise training thrice weekly, nutritional counselling, and nutritional supplements every morning and evening (including 20-25g whey protein and (evening only) 5.5g Biotis™ GOS). We measure immune-metabolic, gut health, muscle mass and physical functioning at baseline and after completion of the intervention/standard care. An additional reference group of healthy older adults (n=50) will undergo baseline measurements only. DiscussionImprovements in various physiological systems are expected, but with differences between groups/individuals. This study will provide insights into how the physiological state of older adults influences the extent of lifestyle-induced health improvements to create better tailored interventions to attenuate biological ageing and improve the health span of subgroups and individuals.

Rehabilitation Outcomes in Diabetic Peripheral Neuropathy: An Evidence-Based Physiotherapy Approach for Functional Improvement – Case

Background: Diabetic Peripheral Neuropathy (DPN) is a prevalent and debilitating complication of diabetes mellitus (DM), affecting up to 70% of individuals with diabetes. DPN impairs motor and sensory functions, leading to pain, muscle weakness, and functional limitations that severely affect the quality of life. Effective rehabilitation strategies, including physiotherapy, are essential for improving these functional outcomes. Methods: This study assessed the effectiveness of a 12-week evidence-based physiotherapy rehabilitation program designed to improve the functional status of a 48-year-old female patient with DPN. The intervention included Transcutaneous Electrical Nerve Stimulation (TENS), range of motion (ROM) exercises, strengthening exercises, balance training, and gait improvement, administered over 45 physiotherapy sessions. Progress was measured using the Visual Analog Scale (VAS), Berg Balance Scale (BBS), and the Timed Up and Go (TUG) test. Results: Following the 12-week intervention, the patient reported significant improvements in pain reduction, with VAS scores decreasing from 9/10 to 4/10. Sensory function improved from impaired to intact, as assessed through light and deep touch sensation tests. Balance scores on the BBS increased from 22 to 48, indicating substantial gains in stability. Gait speed, measured using the TUG test, improved from 35 seconds to 13 seconds. Additionally, there were marked improvements in ROM, muscle strength, and overall functional abilities. Conclusion: The study demonstrates the effectiveness of a structured physiotherapy rehabilitation program in reducing neuropathic pain and improving functional outcomes in patients with DPN. TENS, combined with exercise-based interventions, significantly enhanced pain management, balance, and gait. Long-term monitoring and continued physiotherapy may further optimize the patient’s functional status and quality of life.

Using an integrated motor imagery and physical training intervention after knee injury: an interim analysis of the MOTIFS randomised controlled trial

ObjectivesPhysical function is often a main focus of knee injury rehabilitation, but recent recommendations include increasing attention to psychological factors. We have developed the MOTor Imagery to Facilitate Sensorimotor re-learning...

The Languages of Love Support Group: Exploring quality of life and relationship satisfaction among couples experiencing cancer.

206 Background: Based on Dr. Gary Chapman’s The Five Love Languages (5LL), love is given and received in different ways. By identifying preferences for reciprocating love, relationships are enhanced through strengthened bonds and improved communication. Study goals were to optimize quality of life and reduce pain through improved dyadic communication via support group curriculum adapted from Dr. Chapman’s work. Methods: A research collaboration was established between an academic pharmacy research team and a large community oncology practice. A group of Masters prepared Social Workers (MSWs) within the oncology practice developed a virtual 6-week, cancer specific curriculum targeting the patient-partner couple (dyad). Participants completed 5LL quiz to determine their preferred love language. In each group session facilitated by MSWs, dyads were educated on each love language meaning (words of affirmation, acts of service, receiving gifts, quality time, physical touch) and potential impact following a cancer diagnosis. Weekly sessions included collective discussion and breakout groups consisting of patients and partners separately. Participants took a researcher-designed, pre- and post-test survey. Participants shared their preferred love language and were encouraged to perform actions accordingly. Dyads were mailed infographics with application examples for each love language and received a welcome starter kit including $50 of items. Results: A pilot group of 24 dyads consisting of 3 cohorts were enrolled in the 6-week intervention. Eleven dyads completed pre- and post-tests (45.8%); 100% of dyads were married, greater than 50% more than 20 years. Greater than 80% of participants were 50 years or older, greater than 70% White; 81.8% of patients female and 63.3% of partners male. Patient relationship satisfaction increased significantly (p&lt;0.10) while trend for improved partner relationship satisfaction was not significant. There was a trend of decreased patient depression and anxiety despite patients’ reported pain increasing significantly (p&lt;0.10). The comments regarding intervention were overwhelmingly positive. Conclusions: Educating dyads within the 5LL virtual support group demonstrated a novel and effective way to provide emotional support and enhance intimate relationships. Through this innovative group, participants learned to identify and express partners’ love language. Pilot intervention shows how this approach is useful in improving relationship satisfaction during the cancer journey. Following group participation, patients also reported increased quality of life and decreased depression and anxiety even while reporting increased pain. Based on this evidence, a couples support group constructed from the 5LL paradigm is a promising approach to improve the quality of life of cancer patients.

Long-term transcranial ultrasound stimulation regulates neuroinflammation to ameliorate post–myocardial infarction cardiac arrhythmia and remodeling

BackgroundSympathetic overactivation and neuroinflammation in the paraventricular nucleus (PVN) are crucial factors in post–myocardial infarction (MI) cardiac remodeling and ventricular arrhythmias (VAs). Prior study has indicated that low-intensity focused ultrasound stimulation could attenuate sympathetic neuroinflammation within the PVN to prevent the occurrence of VAs in an acute MI model. Meanwhile, the cGAS-STING pathway has shown potential to ameliorate the neuroinflammatory response. However, the effect and mechanisms of long-term transcranial ultrasound stimulation (LTUS) for modulating neuroinflammation in the chronic stage of MI remain unclear. ObjectiveThis study aimed to ascertain whether LTUS could mitigate post-MI neuroinflammation and improve cardiac arrhythmia and remodeling through the cGAS-STING pathway. MethodsThirty-six SD rats were equally randomized to the sham group (pseudo-MI modeling), chronic MI group (MI modeling), and LTUS group (MI modeling and long-term ultrasound stimulation). Transcranial ultrasound stimulation (15 min/d) was conducted on the PVN for 4 consecutive weeks. After 4-week intervention, echocardiography, electrophysiologic experiments, and histopathologic staining were performed to assess the role of LTUS on post-MI neuroinflammation and cardiac remodeling. ResultsThe results indicated that LTUS significantly facilitated microglial M1 to M2 polarization through the cGAS-STING signaling pathway within the PVN. Furthermore, LTUS inhibited MI-induced sympathetic neuroinflammation, thereby improving cardiac dysfunction, ameliorating cardiac remodeling, and reducing VA inducibility. ConclusionLong-term ultrasound stimulation of the PVN was found to alleviate post-MI neuroinflammation and to improve cardiac remodeling, which might inspire novel insights and clinical strategies for noninvasive neuromodulation and the treatment of post-MI VAs.