Intervention-related Adverse Events Research Articles

Impaired emotion regulation and decreased quality of life are common, yet often untreated, sequelae of stroke. Conventional rehabilitation primarily targets physical and cognitive recovery, leaving affective disturbances unaddressed. This study examined the efficacy of a structured Buddhist meditation program—Mindful Resilience After Stroke (MRAS)—for improving emotion regulation and quality of life in stroke survivors. Forty-two ischemic/hemorrhagic stroke patients (3–18 months post-onset) were consecutively recruited and randomly allocated to an intervention group (n = 21) receiving an 8-week MRAS protocol (1 × 60 min/week) or a control group (n = 21) receiving standard care only. Emotion regulation was assessed with the Difficulties in Emotion Regulation Scale-Short Form (DERS-SF) and quality of life with the Stroke-Specific Quality of Life Scale (SS-QOL). Between-group changes (Δ post-pre) were analyzed using independent t-tests or Mann–Whitney U tests (α = 0.05). The intervention group showed a significantly greater reduction in emotion-regulation difficulties than controls (ΔDERS-SF −18.4 ± 5.1 vs. −3.2 ± 4.3; p < 0.001; d = 1.62). Quality-of-life gains were also larger in the intervention group (ΔSS-QOL 35.7 ± 8.9 vs. 7.1 ± 6.5; p < 0.001; d = 1.89). The most improved sub-domains were emotional acceptance, emotional awareness, and impulse control (DERS-SF), as well as energy, mood, and social participation (SS-QOL). No intervention-related adverse events were reported. MRAS is an effective and safe adjunctive intervention to enhance emotion regulation and quality of life after stroke. Embedding mindfulness practices grounded in Buddhist tradition into stroke rehabilitation offers a holistic, culturally adaptable approach for neuropsychological services in Indonesia.

BACKGROUNDHemorrhage following pancreaticobiliary surgery is a high-risk complication, with a mortality rate of 16%-38%. At present, minimally invasive endovascular intervention comprising superselective arterial embolization (SAE) and covered stent implantation (CSI) is the treatment of choice. However, in certain cases, both SAE and CSI become infeasible.AIMTo evaluate the effectiveness of coil-assisted N-butyl cyanoacrylate (NBCA) embolization in comparison with that of CSI in managing delayed hemorrhage after hepatobiliary–pancreatic surgery when SAE is infeasible.METHODSNinety-eight continuous patients (n = 105 cases; mean age, 58.4 years) with delayed massive hemorrhage who were treated with coil-assisted NBCA embolization (NBCA group, n = 45) and/or CSI (CSI group, n = 60) were retrospectively evaluated between March 2014 and December 2023. Data on technical and clinical success, 30-day mortality, and severe intervention-related adverse events were collected and analyzed.RESULTSThe technical and clinical success rates in the NBCA group (100% and 93.3%, respectively) were significantly higher than those in the CSI group (88.3% and 73.3%, respectively), with a statistically significant difference between the two groups (P = 0.019 and 0.010, respectively). The 30-day mortality rates and major intervention-related complications were 17.8% and 0%, respectively, in the NBCA group and 18.3% and 1.7% in the CSI group, respectively, with no statistically significant difference between the two groups.CONCLUSIONIn terms of technical and clinical success, coil-assisted NBCA embolization was more effective than CSI for managing delayed hemorrhage after hepatobiliary–pancreatic surgery when SAE was not feasible.

Background: Breast cancer survivors frequently experience reduced physical capacity, fatigue, upper-limb dysfunction, and impaired quality of life (QoL) following treatment. Exercise and physiotherapy-based rehabilitation programs are increasingly prescribed, but the magnitude and consistency of their benefits remain under debate. Objective: This systematic review aimed to evaluate the effectiveness and safety of supervised exercise and physiotherapy interventions on functional mobility, muscular strength, fatigue, upper-limb function, and QoL in breast cancer survivors. Methods:A comprehensive literature search of PubMed, Scopus, Web of Science, Cochrane CENTRAL, and ClinicalTrials.gov was conducted up to March 2025. Randomized controlled trials (RCTs) comparing supervised exercise or physiotherapy interventions with usual care, waitlist, or non-exercise controls in adult breast cancer survivors were included. Data were extracted on intervention characteristics, participant demographics, outcomes, and adverse events. Risk of bias was assessed using the Cochrane RoB 2.0 tool, and certainty of evidence was graded using GRADE. Results: Twenty-two RCTs involving 2,260 participants were included. Interventions encompassed aerobic, resistance, and combined programs; water-based therapy; yoga; manual therapy; and multimodal rehabilitation, with durations ranging from 3 weeks to 12 months. Significant improvements in cardiorespiratory fitness were observed across 18 trials, with VO₂max gains of 2.5–4.8 mL/kg/min and six-minute walk distance improvements of 35–90 meters. Muscular strength improved by 10–25% in 12 studies, with resistance training demonstrating the largest effects. QoL increased significantly in 15 trials, with improvements exceeding clinically meaningful thresholds (+7.5 to +10 points on validated scales). Fatigue was reduced in nine RCTs, with moderate pooled effect sizes (SMD ≈ –0.35). Seven trials reported enhanced upper-limb function and range of motion following supervised stretching, strengthening, or manual therapy. No serious intervention-related adverse events were reported. Conclusions: Supervised exercise and physiotherapy interventions are safe and effective in improving fitness, strength, QoL, fatigue, and upper-limb function among breast cancer survivors. Findings support their integration into survivorship care plans, with combined aerobic-resistance programs demonstrating the broadest benefits. Further large-scale RCTs with longer follow-up are warranted to confirm sustained outcomes.

Background: Despite evidence supporting exercise in cancer care, adherence remains low. Nordic Walking (NW), a pole-assisted outdoor activity, may overcome barriers and improve fitness. However, a comprehensive synthesis of its effects on physical fitness in cancer patients is lacking. Objective: To evaluate NW's effects on physical fitness, health-related quality of life (HRQoL), adherence, and safety in patients living with and beyond cancer, compared with no intervention or other exercise programs. Methods: This PRISMA-compliant systematic review and meta-analysis (PROSPERO: CRD42024551608) included randomized or quasi-randomized trials. Five databases were searched through November 2024. Risk of bias (Joanna Briggs Institute) and evidence certainty (GRADE) were assessed. Results: This systematic review included six RCTs comparing NW with no intervention. NW significantly improved overall muscle strength (Std. MD = 0.46, 95%CI:0.14-0.78; low-certainty) and self-reported physical activity (MD = 3181.51 MET-min/week, 95%CI:2085-4278; moderate-certainty). Cardiorespiratory fitness (6-min walk) showed no significant improvement in random-effects modeling (MD = 84.78 m, 95%CI:-35.6-205.19; very low-certainty). HRQoL data were insufficient for meta-analysis. Adherence exceeded 90% in supervised sessions, with no serious intervention-related adverse events. Conclusions: When compared with no intervention NW is feasible and safe, potentially improving muscle strength and physical activity in patients with cancer. Evidence for cardiorespiratory endurance and HRQoL remains inconclusive. To date, no studies have compared NW with other structured exercise programs. Higher-quality RCTs with diverse populations are needed.

Managing Parkinson's disease (PD) symptoms can be challenging due to multiple factors, including complex symptoms, which are often reported late, and a lack of resources, resulting in worse outcomes. Self-management of PD symptoms is a priority for patients, their carers, healthcare staff and systems. However, there is no effective comprehensive self-management intervention for use in the United Kingdom to support people with PD to self-manage problematic symptoms. We have developed a facilitated self-management toolkit through literature reviews and co-design workshops. We conducted a single-group, pre–post feasibility study to evaluate the feasibility and acceptability of this toolkit, ahead of a randomised controlled trial (RCT). We assessed the feasibility of the study by measuring recruitment rate, retention rate, data completion, outcome measures and serious adverse events. In addition, we collected fidelity data to ensure the intervention was delivered as designed. For acceptability, we measured participants' engagement through attendance at sessions, as well as through a feedback survey completed by participants at follow-up. In a subgroup of participants, we conducted semistructured interviews to gain feedback on what participants thought was good and what could be improved with the intervention, as well as how acceptable the trial procedures were. All quantitative data were summarised descriptively, and qualitative data were analysed using codebook thematic analysis. We successfully recruited the target population within a predefined timeline, maintained intervention engagement and completed sufficient follow-up, with limited missing data and no intervention-related serious adverse events. The intervention was delivered with 93% fidelity, and 89% of participants were engaged. Participants found the supporter sessions most helpful, followed by information pages, and setting person-centred goals. Having all their PD information in one place was seen as valuable, as well as talking through their challenges and problem-solving how to overcome them. The toolkit is now being tested in a national RCT.Trial Registration: ISRCTN registry: ISRCTN92831552

Stroke increases the risk of cognitive impairment and dementia without proven prevention therapies. Cardiorespiratory exercise (CRX) preserves brain health. To determine whether a CRX intervention preserves hippocampal volume (HV) and cognition in patients after ischemic stroke. The Post-Ischemic Stroke Cardiovascular Exercise Study (PISCES)-Zoom Delivered Intervention Against Cognitive Decline (ZODIAC) is a phase 2b assessor-blinded randomized clinical trial performed at 4 metropolitan health care services in Melbourne, Australia. Eligible participants included adult patients who survived ischemic stroke without comorbidities prohibiting exercise or diagnosed cognitive disorder. Participants were recruited from May 26, 2016, to March 20, 2020, for PISCES in-person training and from November 9, 2020, to February 12, 2024, for ZODIAC remotely delivered home training. A total of 6921 participants were screened for eligibility, 130 were recruited, 107 were randomized (34 in PISCES and 73 in ZODIAC), and 104 continued to intervention. Study visits at 2, 4, and 12 months post stroke included brain magnetic resonance imaging and cognitive testing. Participants were randomized (1:1), stratified by baseline function (modified Rankin Scale score of 0-1 vs 2-3) and total brain volume. Primary, secondary efficacy, and safety outcome analyses were conducted using modified intention-to-treat (mITT) principle and per protocol. Participants received 8 weeks of three 60-minute sessions/wk. Participants in the CRX group received prescribed intensity progressive aerobic and resistance training; the control group received balance and stretching training. The primary outcome was relative change in HV calculated as the difference between HV at times 1 and 2 divided by HV at time 1. Secondary outcome consisted of 12-month executive function test results (Trial Making Test, Part B [TMT-B]), adjusted for baseline TMT-B and mRS score. The 104 participants included in primary outcome mITT analysis (55 in the control and 49 in the CRX groups; mean [SD] age, 64 [14] years; 67 [64.4%] male; equivalent baseline mRS score). One hundred participants (33 in PISCES and 67 in ZODIAC) completed 4-month assessments, and 97 (31 in PISCES and 66 in ZODIAC) completed 12-month assessments. There were no intervention-related serious adverse events. Mean (SD) difference in relative change in HV between the CRX (-0.26% [2.12%]) and control (-0.11% [2.35%]) groups was -0.10% (95% CI, -1.10% to 0.87%; P = .83). The CRX group (n = 43) performed better than the control group (n = 51) on the adjusted TMT-B at 12 months (adjusted mean difference, -3.75 [95% CI, -5.02 to -2.49] seconds). In this randomized clinical trial of fitness training, CRX was safe but did not preserve HV more than a control condition. CRX may benefit cognitive preservation following ischemic stroke. anzcrt.org Identifier: ACTRN12616000942459.

To determine the feasibility of low-load resistance blood flow restriction training (BFRT) in people with Parkinson disease (PD). This prospective cohort, convergent parallel mixed-methods design investigated the feasibility of 8weeks of low-load resistance BFRT in people with PD. Feasibility was determined by enrolling 20 participants,≥80% retention and adherence, and no serious intervention-related adverse events. Semistructured interviews and questionnaires evaluated acceptability and satisfaction. Changes in muscle strength and thickness, mobility, physical activity, and patient-reported outcomes were also assessed. Sixteen of 20 participants (80%) were retained at the postintervention assessment (68.1±8.6years old, 44% Female), completing 88% of visits with no serious adverse events. Qualitative analysis identified 3 themes: satisfaction and acceptability, functional capacity changes, and program feedback. Most participants were satisfied (88%), and lack of satisfaction was primarily related to pressure intolerance and exercise specificity. There were improvements in knee extension and ankle plantarflexion strength (18-22%), 30-Second Sit to Stand (+2.2 reps), Timed Up and Go (-2.1seconds), and 10-Meter Walk Test (0.12 m/s). The average daily step count decreased (-476 steps/day) and sedentary time increased (21minutes/day). There were minimal changes in elbow extension strength, rectus femoris muscle thickness, Parkinson's Fatigue Scale, and Patient-Specific Functional Scale. BFRT was feasible and safe in people with PD, with promising improvements in muscle strength and mobility, warranting a future efficacy study. Clinicians considering BFRT should carefully evaluate tolerance and make sure BFRT aligns with patient goals.

Mild cognitive impairment (MCI) is the transitional stage between normal aging and early dementia. Although acupuncture is a promising non-pharmacological treatment, higher-quality evidence is needed to confirm its effectiveness. A randomized, patient- and assessor-blinded, sham-controlled, pilot clinical trial was conducted to evaluate the feasibility of acupuncture for treating MCI. In total, 30 participants were randomized into acupuncture and sham acupuncture groups. The participants underwent 24 treatment sessions over 12 weeks. The primary outcome was a change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) score over 12 weeks, whereas the secondary outcomes included the Seoul Neuropsychological Screening Battery (SNSB-II) score. Adverse events and the success of blinding were also assessed. Of the 30 participants, 28 completed the study. Participants in the acupuncture and sham acupuncture groups exhibited a decrease in ADAS-cog scores from 10.27 ± 4.03 and 11.47 ± 3.85 at baseline to 5.78 ± 3.04 and 6.27 ± 2.83 at week 12, respectively. Both groups exhibited clinically meaningful improvements, with no significant difference between groups (P = 0.6590). The SNSB-II memory domain exhibited a moderate effect size favoring acupuncture (Cohen's d = 0.57, P = 0.1317). No intervention-related adverse events were reported, and participant blinding was adequate throughout the trial. The 12-week acupuncture treatment is feasible for patients with MCI and may improve memory. Although the primary outcomes did not reach statistical significance, the secondary outcomes suggested potential benefits. Larger confirmatory trials are warranted to investigate the effectiveness of acupuncture in patients with MCI. Clinical Research Information Service (cris.nih.go.kr) KCT0001938 (Registered on June 3, 2016).

Background: Chronic liver diseases (CLDs) are major contributors to hepatic disorder-related morbidity and mortality worldwide. LIV-52, a herbo-mineral product, has demonstrated anti-inflammatory and immunomodulatory properties. Objective: Several randomized controlled trials (RCTs) have been conducted to verify its hepatoprotective effects across diverse patient groups with CLDs. This study aims to perform a meta-analysis to evaluate the therapeutic efficacy of LIV-52 in liver diseases. Data Sources: PubMed, the Cochrane Library, EMBASE, and Web of Science were searched to identify eligible RCTs published through March 10, 2025, where the efficacy of LIV-52 was compared with usual treatments for liver diseases. Meta-analysis was performed using RevMan and GRADEPro software. Eligibility Criteria: RCTs comparing LIV-52 with or without standard care in patients with CLDs. Data Collection and Analysis: Data were extracted independently by two reviewers. Meta-analysis was performed using a random-effects model. Results: From the 10 RCTs involving 758 patients, the hepatoprotective effects of LIV-52 treatment were examined. Benefits were noted in the areas of appetite loss (odds ratio = 0.25, confidence interval [CI] = 0.06 to 1.00, p-value = 0.05), renormalization of the liver enzyme serum-glutamic-pyruvic transaminase (SGPT; mean difference [MD] = -16.37, CI = -30.87 to -1.88, p-value <0.03), and improvement in fat metabolism in patients with liver cirrhosis (zinc sulfate [ZnS] turbidity [MD = 6.76, CI = 2.4 to 11.12, p-value <0.002] and fecal fat secretion [MD = -1.66, CI = -2.53 to -0.75, p-value <0.0001]). However, no significant effects of LIV-52 were observed for liver enzymes such as serum-glutamic-oxaloacetic transaminase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin, and the hematological parameters. The overall quality of evidence (QoE) as assessed using GRADEPro ranged from very low to moderate, with the majority of comparisons supported by low or very low due to small sample sizes and high bias risks, while the findings for some outcomes, hemoglobin and prothrombin time outcomes, supported moderate-quality evidence. Adverse events (AEs) were assessed in three RCTs; no intervention-related AEs were reported. Conclusion: The findings of this meta-analysis suggest that LIV-52 offers certain hepatoprotective benefits, particularly in improving appetite, normalizing SGPT levels, and enhancing fat metabolism in patients with liver diseases. The broader efficacy of LIV-52 is limited, and the low QoE warrants cautious interpretation. Further high-quality, large-scale studies are needed to enhance the certainty of evidence and confirm the LIV-52 efficacy and safety across all outcomes.

This study investigates the acceptability of a novel Cognitive Bias Modification for Interpretation (CBM-I) intervention, 'FRAME', to promote resilience in women who have completed active treatment for primary breast cancer and determines the feasibility of a full-scale randomised controlled trial. A two-armed, participant-blind, parallel groups randomised controlled trial of CBM-I versus a time-matched control. Participants were recruited from community organisations and social media. Measures of acceptability, feasibility, change in interpretation bias and clinical outcomes (resilience, mood and quality of life) were assessed at baseline (T0), 1-month post-randomisation (T1, end of intervention), 2-month (T2) and 4-month post-randomisation (T3). Sixty-seven participants completed baseline assessment and were randomised to the FRAME CBM-I (n=35) or control group (n=32). Acceptability of CBM-I met pre-specified progression criteria, and 80% adhered to the CBM-I intervention. Between-group differences in interpretation bias at T1 demonstrated a moderate effect in favour of CBM-I on two measures of interpretation bias (SMDg=0.66 and 0.73). Effect size estimates suggest moderate treatment effects on resilience (SMDg=0.64) and small effects on mood, in favour of FRAME. No intervention-related adverse events were reported. The study results provide strong support for the acceptability of a new online CBM-I intervention ('FRAME') to promote resilience in women treated for primary breast cancer and indicate that a full-scale trial is feasible. The study fulfiled all pre-specified progression criteria to advance to an efficacy trial, except meeting the recruitment target of 70 participants. Importantly, recruitment took place during the Covid-19 pandemic. Recommendations for future research are provided.

ObjectiveThis study aimed to assess the methodological quality of published systematic reviews of exercise therapy in knee osteoarthritis and summarise their reported effectiveness on quality of life, knee joint function, or adverse events.DesignOverview of systematic reviews.Data sourcesPubMed, Embase, CINAHL, Web of Science and CENTRAL (searched on 14 April 2025), plus grey literature (PROSPERO, Epistemonikos, OpenGrey).Eligibility criteria for selecting studiesWe included systematic reviews of randomised controlled trials in patients diagnosed with knee osteoarthritis by imaging or clinical criteria and treated conservatively with exercise therapy; we excluded reviews that enrolled patients scheduled for surgery, with acute inflammation or osteoarthritis of other joints (hand, hip, ankle), for which relevant author data could not be obtained after one contact attempt, or that did not report at least one primary outcome (quality of life, knee joint function or adverse events).Data extraction and synthesisTwo reviewers independently extracted data on study characteristics, interventions and outcomes, and assessed methodological quality using the AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews 2) tool. Due to heterogeneity in outcome measures across systematic reviews, meta-analysis was not conducted. Effectiveness was defined as any reported beneficial outcome of exercise therapy on predefined outcomes, including quality of life, physical function, pain or adverse events.Results58 systematic reviews were selected. Muscle-strengthening (74.1%) and aerobic (48.2%) exercises were the most commonly prescribed exercise-based interventions. SF-36 (36-Item Short Form Health Survey) and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) were the most popular outcome-evaluation tools. Furthermore, 63.7% of the systematic reviews revealed that exercise therapy improved all outcomes. The number of intervention-related adverse events was small. Notably, almost all systematic reviews (87.4%) had a critically low quality.ConclusionsCurrent evidence on exercise therapy for knee osteoarthritis is inadequate. Nevertheless, exercise therapy can be considered for conservative treatment of knee osteoarthritis. Future studies should use network meta-analyses to compare the effects of different exercise therapies and determine their superiority over other conservative therapies.

12131 Background: Psychological distress is highly prevalent among cancer survivors, and it interferes with their ability to recover after treatment and resume normal life activities. Yoga is a promising therapy that may reduce psychological distress and facilitate optimal recovery for survivors. However, accessibility can be limited for survivors who have higher risks of infection due to immunosuppression or high travel burden. Virtual delivery of yoga may increase accessibility for survivors. Methods: We conducted a decentralized, digital, phase II randomized controlled trial (RCT) examining the efficacy of virtual yoga compared to usual care for improving psychological distress among survivors. Participants were cancer survivors who completed primary treatment (e.g., surgery, chemotherapy, radiation therapy) within the last 2-60 months. Participants were randomized to receive virtual yoga or usual care. The Zoom platform was used to virtually deliver the Yoga for Cancer Survivors (vYOCAS) intervention. vYOCAS is a 4-week intervention based on gentle Hatha and restorative yoga. Each yoga session was delivered by a certified yoga instructor in small groups (2-4 survivors/group) for 75 minutes, twice a week. Psychological distress was assessed via the Profile of Mood States (POMS) at baseline and post-intervention. POMS evaluated tension-anxiety, depression, anger-hostility, fatigue, confusion, and overall mood. T-tests and ANCOVAs with baseline as a covariate were used to evaluate within- and between-group changes, respectively. Results: 42 survivors (93% female; mean age 58.5±11.6 years; 60% breast cancer; 17% residing in small town/underserved areas) were randomized and completed the study. On average, participants attended 6.2 of 8 prescribed yoga sessions. 44% of vYOCAS participants reported additional home practice of 62.8 minutes over 4 weeks. vYOCAS participants reported significant decreases in psychological distress (tension-anxiety: -1.5±0.6; depression: -1.2±0.4; fatigue: -2.4±0.7; overall mood: -7.3±2.4; all p &lt; 0.05) at post-intervention. Usual care participants did not demonstrate similar improvements. ANCOVA results also revealed that vYOCAS participants experienced significantly greater improvements in fatigue (-2.1±0.8, p = 0.02) and overall mood (-6.4±3.1, p = 0.04) compared to usual care participants. No intervention-related adverse events were reported and the majority of survivors would recommend virtual yoga to others. Conclusions: vYOCAS is safe, feasible, and amenable for cancer survivors. vYOCAS may also significantly improve psychological distress.Clinicians should consider recommending virtual yoga therapy for survivors with psychological distress to overcome barriers related to accessibility. Future phase III decentralized digital RCTs are needed to confirm these findings. Clinical trial information: NCT04458194 .

BackgroundThe inability to appropriately react to balance perturbations is a common cause of falls. Perturbation-based balance training (PBT) is especially beneficial for improving reactive balance and shows high potential for fall prevention. However, its dose–response relationship, feasibility, and acceptability remain to be determined among older adults at risk of falling. The FEATURE study aimed to compare the efficacy of two treadmill PBT protocols with different session numbers to improve reactive balance, and to evaluate their feasibility and acceptability in this population.MethodsIn this randomized controlled pilot trial, 36 older adults at risk of falling were allocated to receive either six (6PBT) or two treadmill PBT sessions (2PBT). Reactive balance in standing (Stepping Threshold Test [STT]) and walking (Dynamic Stepping Threshold Test [DSTT]) was assessed as primary outcome at baseline (T1), post-intervention (T2), and 6-week follow-up (T3). Secondary outcomes included measures on physical, psychological, and cognitive functioning. Feasibility was assessed via PBT adherence, planned perturbations completed, and adverse events; acceptability via questionnaire. Between-group changes over time were compared using repeated-measures analyses of variance with Bonferroni-corrected post-hoc tests. Data analyses followed the intention-to-treat principle.ResultsA significant time effect was observed for the DSTT (p = 0.008), with both groups significantly improving from T1 to T2 (ps < 0.01). A significant interaction effect (p = 0.027) revealed that only the 6PBT group maintained these improvements (T1 vs. T3: p < 0.001) and scored significantly higher than the 2PBT group at T3 (p = 0.015). No significant interaction effects were found for the STT or any secondary outcome, but improvements over time were observed for dynamic balance, gait capacity, functional mobility, physical activity, concerns about falling, and executive functioning (time effects: ps < 0.05). PBT adherence, planned perturbations completed, and acceptability were high in both groups, with no significant between-group differences. No intervention-related serious adverse events were reported.ConclusionsFindings suggest that a low number of treadmill PBT sessions can lead to task-specific improvements in reactive balance during walking, with a higher practice dose enhancing sustainability. Treadmill PBT appears feasible and well-accepted among older adults at risk of falling, regardless of sessions received.Trial registrationDRKS00030805; prospectively registered December 14, 2022.

Exercise interventions for older adults with advanced cancer: A scoping review.

To investigate the effect of canine-assisted intervention (CAI) on anxiety symptoms among intensive care patients and their family members. Prospective, single-center, single-arm, nonrandomized, within-subject study design. Tertiary hospital ICU. Adult (≥ 16 yr) ICU patients and their family members. Individual CAI (therapy dog) sessions, lasting at least 15 minutes. Primary outcome: change in Visual Analog Scale for Anxiety (VAS-A) among patients and family members; secondary outcomes (patient cohort): change in: 1) Numeric Pain Rating Scale, 2) physiologic vital signs, and 3) intervention-related adverse events. A total of 141 participants (70 patients and 71 family members) were recruited. The median (interquartile range [IQR]) age (yr) was 63 (49-71) for patients, and 51 (36-61) for family members. There was a significant reduction in anxiety scores after the intervention, with median (IQR) VAS-A scores changing from 5 (1-7) to 0 (0-4 [p < 0.001]) for the patient cohort and from 6 (5-8) to 3 (1-5 [p < 0.001]) for the family cohort. Majority of patients (56/70 [62%]) and family members (63/68 [93%]) demonstrated a greater than or equal to 2-point reduction in VAS-A scores. In terms of pain, median (IQR) scores among the patient cohort were also lower post-intervention (0 [0-5] vs. 0 [0-2]; p < 0.001). There were no statistically significant changes in physiologic vital signs (heart rate, respiratory rate, and systolic blood pressure) among patients following the intervention. Additionally, there were no reported dog bites, scratches, or other adverse events during CAI. CAI offers immediate therapeutic benefits in reducing anxiety symptoms in ICU patients and their family members with no observed adverse effects. It may also have a potential role as an adjunctive therapy for pain management in ICU patients. Further research should explore the influence on longer-term psychologic outcomes for ICU patients and family members.

This article consists of a citation of a published article describing research funded by the Efficacy and Mechanism Evaluation programme under project number NIHR134607, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1016/S2213-2600(22)00186-2 Background Immunosuppressive treatments inhibit vaccine-induced immunity against SARS-CoV-2. We evaluated whether a 2-week interruption of methotrexate treatment immediately after the COVID-19 vaccine booster improved antibody responses against the S1 receptor-binding domain (S1-RBD) of the SARS-CoV-2 spike protein compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases. Methods We did an open-label, prospective, two-arm, parallel-group, multicentre, randomised, controlled, superiority trial in 26 hospitals in the UK. We recruited adults from rheumatology and dermatology clinics who had been diagnosed with an immune-mediated inflammatory disease (eg, rheumatoid arthritis, psoriasis with or without arthritis, axial spondyloarthritis, atopic dermatitis, polymyalgia rheumatica, and systemic lupus erythematosus) and who were taking low-dose weekly methotrexate (≤25 mg per week) for at least 3 months. Participants also had to have received two primary vaccine doses from the UK COVID-19 vaccination programme. We randomly assigned the participants (1:1), using a centralised validated computer randomisation program, to suspend methotrexate treatment for 2 weeks immediately after their COVID-19 booster (suspend methotrexate group) or to continue treatment as usual (continue methotrexate group). Participants, investigators, clinical research staff, and data analysts were unmasked, while researchers doing the laboratory analyses were masked to group assignment. The primary outcome was S1-RBD antibody titres 4 weeks after receiving the COVID-19 booster vaccine dose, assessed in the intention-to-treat population. This trial is registered with ISRCT, ISRCTN11442263; following the pre-planned interim analysis, recruitment was stopped early. Findings Between Sept 30, 2021 and March 3, 2022, we recruited 340 participants, of whom 254 were included in the interim analysis and had been randomly assigned to one of the two groups: 127 in the continue methotrexate group and 127 in the suspend methotrexate group. Their mean age was 59·1 years, 155 (61%) were female, 130 (51%) had rheumatoid arthritis, and 86 (34%) had psoriasis with or without arthritis. After 4 weeks, the geometric mean S1-RBD antibody titre was 22 750 U/mL (95% CI 19 314-26 796) in the suspend methotrexate group and 10 798 U/mL (8970-12 997) in the continue methotrexate group, with a geometric mean ratio (GMR) of 2·19 (95% CI 1·57-3·04; p&lt;0·0001; mixed-effects model). The increased antibody response in the suspend methotrexate group was consistent across methotrexate dose, administration route, type of immune-mediated inflammatory disease, age, primary vaccination platform, and history of SARS-CoV-2 infection. There were no intervention-related serious adverse events. Interpretation A 2-week interruption of methotrexate treatment for people with immune-mediated inflammatory diseases resulted in enhanced boosting of antibody responses after COVID-19 vaccination. This intervention is simple, low-cost, and easy to implement, and could potentially translate to increased vaccine efficacy and duration of protection for susceptible groups. Funding National Institute for Health and Care Research. Funding This publication was funded by the Efficacy and Mechanism Evaluation programme as a part of award number NIHR134607. This article reports on one component of the research award Vaccine Response On/Off Methotrexate (VROOM): does temporarily suspending methotrexate treatment for two weeks enhance COVID-19 vaccine response? A randomised controlled trial. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/NIHR134607] DOI https://doi.org/10.1016/S2213-2600(22)00186-2

This article consists of a citation of a published article describing research funded by the Efficacy and Mechanism Evaluation programme under project number NIHR134607, and is provided as as part of the complete record of research outputs for this project. The original publication is available at: https://doi.org/10.1016/S2665-9913(23)00298-9 Summary Background Methotrexate is the first-line treatment for immune-mediated inflammatory diseases and reduces vaccine-induced immunity. We evaluated if a 2-week interruption of methotrexate treatment immediately after COVID-19 booster vaccination improved antibody response against the S1 receptor binding domain (S1-RBD) of the SARS-CoV-2 spike protein and live SARS-CoV-2 neutralisation compared with uninterrupted treatment in patients with immune-mediated inflammatory diseases. Method We did a multicentre, open-label, parallel-group, randomised, superiority trial in secondary-care rheumatology and dermatology clinics in 26 hospitals in the UK. Adults (aged ≥18 years) with immune-mediated inflammatory diseases taking methotrexate (≤25 mg per week) for at least 3 months, who had received two primary vaccine doses from the UK COVID-19 vaccination programme were eligible. Participants were randomly assigned (1:1) using a centralised validated computer program, to temporarily suspend methotrexate treatment for 2 weeks immediately after COVID-19 booster vaccination or continue treatment as usual. The primary outcome was S1-RBD antibody titres 4 weeks after COVID-19 booster vaccination and was assessed masked to group assignment. All randomly assigned patients were included in primary and safety analyses. This trial is registered with ISRCTN, ISRCTN11442263; following a pre-planned interim analysis, recruitment was stopped early. Finding Between Sept 30, 2021, and March 7, 2022, we screened 685 individuals, of whom 383 were randomly assigned: to either suspend methotrexate (n=191; mean age 58·8 years [SD 12·5], 118 [62%] women and 73 [38%] men) or to continue methotrexate (n=192; mean age 59·3 years [11·9], 117 [61%] women and 75 [39%] men). At 4 weeks, the geometric mean S1-RBD antibody titre was 25 413 U/mL (95% CI 22 227-29 056) in the suspend methotrexate group and 12 326 U/mL (10 538-14 418) in the continue methotrexate group with a geometric mean ratio (GMR) of 2·08 (95% CI 1·59-2·70; p&lt;0·0001). No intervention-related serious adverse events occurred. Interpretation 2-week interruption of methotrexate treatment in people with immune-mediated inflammatory diseases enhanced antibody responses after COVID-19 booster vaccination that were sustained at 12 weeks and 26 weeks. There was a temporary increase in inflammatory disease flares, mostly self-managed. The choice to suspend methotrexate should be individualised based on disease status and vulnerability to severe outcomes from COVID-19. Funding National Institute for Health and Care Research. Funding This publication was funded by the Efficacy and Mechanism Evaluation programme as a part of award number NIHR134607. This article reports on one component of the research award Vaccine Response On/Off Methotrexate (VROOM): does temporarily suspending methotrexate treatment for two weeks enhance COVID-19 vaccine response? A randomised controlled trial. For more information about this research please view the award page [https://fundingawards.nihr.ac.uk/award/NIHR134607] DOI https://doi.org/10.1016/S2665-9913(23)00298-9

BackgroundMood episodes and high suicide risk of bipolar disorder (BD) are thought to derive from amygdala–ventral prefrontal cortex emotion regulation brain circuitry dysfunction and resulting emotion dysregulation, making these potential...

Telerehabilitation (TR) can be as effective as in-clinic therapy; however, the implementation of barriers and facilitators to TR is unknown, especially in the underserved and rural population. In addition to TR, self-management support (SMS) interventions have been successful in improving outcomes for stroke survivors using telehealth. We explored the following: (1) Is an intensive multidisciplinary TR intervention combined with SMS feasible to deliver virtual postacute stroke care? (2) Does an intensive TR intervention combined with SMS lead to improvements in level of impairment, functional outcomes, and quality of life? (3) Does an intensive TR intervention combined with SMS impact patient goal attainment? (4) What barriers and facilitators to TR are perceived by stroke survivors? Virtually assisted home rehabilitation after acute stroke-2 offered two sessions of rehabilitation therapy, 3 days a week, for 4 weeks, consisting of two of the following disciplines: occupational therapy, physical therapy, or speech therapy. SMS was offered during the first and last session each week. Quantitative outcomes were completed at baseline assessment (week 1), postintervention assessment (week 6), and final assessment (week 10). Following grounded theory, semi-structured qualitative interviews were completed to identify barriers and facilitators of TR. A total of N = 15 participants were consented into the program. When excluding the 3 participants who withdrew within or before week 1 of intervention, the average weekly number of therapy sessions completed by the remaining 12 participants was 5.6 (standard deviation [SD] 0.79), 5.6 (SD 0.90), 5.2 (SD 2.19), and 4.9 (SD 1.98) for weeks 2-5, respectively. Posterior probability (PP) results indicated very strong (PP >97%) to extreme (PP >99%) support in favor of change over time across most outcomes, including decreased modified Rankin Scale (marginal improvement of -0.731) and Patient Health Questionnaire scores (-3.606) and increased Montreal Cognitive Assessment (+4.178). Nine participants took part in the semi-structured interviews, and two major themes emerged: 1-"Perceived Access/Delivery" and 2-"Perceived Therapy Advantages." In regard to the goal attainment, low sample sizes limited precision for analyses, thus these were not included in analyses. TR after acute stroke is feasible, though barriers still exist. This study proved to be a safe and attainable option for underserved populations of stroke survivors, demonstrating high attendance, improved outcomes, and no intervention-related adverse events.

This pilot study examined the feasibility of a proximal muscle resistance training program to improve walking in people with multiple sclerosis using a combination of in-person, virtual, and independent exercise sessions. People with multiple sclerosis (Expanded Disability Status Scale Score is <6.0) were recruited to a study of resistance training exercises targeting hip abduction and trunk muscles for 10weeks. Feasibility criteria were: enrolling 40 participants, retaining ≥80%, ≥80% visit adherence, no serious intervention-related adverse events, and ≥80% satisfaction. The 6-Minute Walk Test, Timed 25-Foot Walk Test, muscle performance (hip abduction and lateral trunk flexion strength, and trunk flexion endurance), patient-reported outcomes, daily step count, and pelvis and trunk kinematics were measured before and after intervention. Patient-reported outcomes and step count were measured again 12weeks after intervention. Twenty-eight people (median Expanded Disability Status Scale is 3.5) enrolled and 92.8% were retained. Visit adherence was 86.5% (96% for virtual visits, 74% for in-person visits), and 48% of participants preferred virtual visits, while 20% preferred in-person visits. There were no serious intervention-related adverse events, and there was 100% satisfaction. Following intervention, 6-Minute Walk Test distance increased 29.6 m (95% confidence interval [CI], 12.2-47.0), Timed 25-Foot Walk Test decreased by 0.57seconds (95% CI, -0.85 to -0.29), and all muscle performance outcomes improved. Patient-reported outcomes also improved immediately following intervention. There were no changes in average daily step count or trunk and pelvis kinematics. This proximal muscle resistance training program was feasible, with benefits in walking and muscle strength, warranting a future efficacy study.