Assessment Of Functional Capacity Research Articles

Evaluation of upper extremity functional capacity and activities of daily living in patients with heart failure: A cross-sectional study

BackgroundConsidering the limitations in activities of daily living (ADL) and the impact of improvements in patients with heart failure (HF), appropriate assessment of upper extremity functional capacity and ADL is important. ObjectivesTo evaluate upper extremity functional capacity and ADL in patients with HF and compare them with healthy controls. MethodsThis study included 30 HF patients and healthy controls. Upper extremity functional capacity was assessed with the 6-Minute Pegboard Ring Test (6PBRT), ADL by the Londrina protocol, exercise capacity by 6-Minute Walk Test (6MWT), peripheral muscle strength by hand dynamometer, and dyspnea by Modified Medical Research Council Scale (MMRC). For performance tests, pre-test (resting) and post-test (after performance) values ​​were also measured. ResultsPatients with HF with ejection fraction ≤50 % and controls were similar in terms of age (52.63±6.2 and 50.03±6.5 years, respectively) and gender (25 females for each group) (p > 0.05). Patients showed a statistically significant increase in total test time in the Londrina protocol and fewer rings moved in 6PBRT (p < 0.0001). The post-test dyspnea (p = 0.03) and pre-test arm fatigue (p < 0.0001) were observed to be higher in patients in the Londrina protocol. There was a statistically significant group by time interaction in the patients’ pre- and post-test lower heart rate (F= 4.80, p = 0.03), post-test dyspnea (p < 0.0001), and post-test arm fatigue (p = 0.005) were observed to be higher in patients in 6PBRT. ConclusionsThe evidence showed a decrease in upper extremity functional capacity in patients with HF. Patients required more time to perform their ADLs compared with healthy controls.

Paraoxonase I Activity and Its Relationship with Nutrition in Amyotrophic Lateral Sclerosis.

Background: Amyotrophic lateral sclerosis (ALS) is characterized by progressive motor neuron degeneration, with oxidative stress playing a key role. Paraoxonase 1 (PON1) is an antioxidant enzyme that may influence ALS progression. This study aimed to establish a predictive model for the influence of PON1 activity on functionality in ALS patients and explore its relationship with nutrition. Methods: In this observational cross-sectional study, 70 ALS patients underwent assessments of PON1 activity, lipid profile, functional capacity, respiratory function, and heart rate variability. A structural equation model was developed to determine the relationships between variables. Nutritional intake was analyzed in 65 patients. Results: The predictive model showed that PON1 activity and LDL levels positively influenced functionality, both directly and indirectly through respiratory capacity. Heart rate variability moderately predicted functionality independently. HDL levels were not significantly associated with functionality. Weak to moderate correlations were found between PON1 activity and intake of certain nutrients, with positive associations for monounsaturated fats and vitamin D, and negative associations for carbohydrates, proteins, and some micronutrients. Conclusions: PON1 activity appears to play an important role in ALS patient functionality, both directly and through effects on respiratory capacity. However, its relationship with nutritional intake was not strongly evident in this sample population.

Location-based differences in cognition and functional capacity: Consistent levels of impairment in participants with schizophrenia compared to healthy controls

Cognitive performance manifests regional differences, correlated with education. There is less information available about regional differences in performance-based measures of functional capacity. In multi-national trials focused on cognitive enhancement, it may be impossible to validate every measure in all locations. It is unknown if regional differences in healthy controls’ (HC) performance affects relative levels of impairment in participants with schizophrenia (SCZ). A multi-site study comparing SCZ and HC administered the MATRICS Consensus Cognitive Battery (MCCB) and Virtual Reality Functional Capacity Assessment Tool (VRFCAT) to 164 HC participants and 164 with SCZ across three sites (Columbia, SC, Miami, and San Diego) and a representative sample of HC (n = 390) completed the VRFCAT in Durham, NC. Performance was compared between HC and SCZ participants at the validation sites. There were statistically significant cross-site differences in HC performance on both the MCCB and VRFCAT. Differences between HC and SCZ on MCCB and VRFCAT were substantial at all three sites, indicating that regional variations in HC performance did not induce reduced differences from SCZ participants. Regional differences were smaller than diagnostic group differences, suggesting that relative impairments of participants with SCZ is consistently preserved across performance differences in HC.

The influence of the health status and functional capacity assessment of older people with heart failure on the participation in a cardiac rehabilitation program after myocardial infarction

Abstract Background Cardiac rehabilitation (CR) after myocardial infarction (MI), conducted by a multidisciplinary team, is considered to be the most effective secondary prevention strategy. CR might be particularly beneficial in older patients, who often suffer from heart failure (HF) and other comorbidities. Low enrolment in CR programs is observed in various age groups despite the proven effectiveness of CR in the reduction of subsequent ischemic episodes, hospitalization, and mortality risk. Purpose The study aimed to analyze the impact of the health status and functional capacity assessment of elderly patients with HF using the Vulnerable Elders Survey (VES-13) scale on the willingness to participate in the CR program as part of the national Comprehensive Care Program after Myocardial Infarction. Methods The analysis of the medical records of MI patients, who were hospitalized between 2017 and 2023 and met the inclusion criteria for CR was performed. People included in the study were ≥60 years of age and had previously been diagnosed with HF. The study included 350 people who underwent VES-13 assessment during hospitalization. The median age of the studied group was 74 (IQR 68-81), with the majority of males (59.1%). Results The willingness to participate in CR was declared by 26.3% of respondents. The median VES-13 score was 3 (IQR 2-7) points and was higher in patients who did not want to participate in CR [3 (IQR 2-7) vs 2 (IQR 1-3), p &amp;lt;0.0001]. In the group of patients who scored &amp;lt;3 points in the VES-13 scale, there was a significantly higher percentage of patients declaring their willingness to participate in CR compared to the group with ≥3 points (38.8% vs 18.5%, p=0.0001). Univariate analysis showed that all parameters assessed by the VES-13 scale had a significant impact on patients' willingness to participate in CR (Figure 1). Independent factors determining patients' declaration were age, difficulties in reaching or extending arms above the shoulder level, and limitations in shopping for personal items (like toilet items or medicines) (Figure 2). Conclusion The VES-13 scale can help to identify patients with HF after MI who require additional support and motivation in the decision process to participate in coordinated care and early CR. Limitations in the everyday functioning of elderly patients with HF determine the lack of willingness to participate in CR after MI. It is necessary to carry out intensive educational and motivational activities to improve the recruitment to the CR program.

Sleep apnea in schizophrenia: Estimating prevalence and impact on cognition

Undertreated medical illnesses can compound the disabling cognitive deficits of schizophrenia. Obstructive sleep apnea (OSA) impairs cognitive domains also affected by schizophrenia, is common, and is treatable. The effects of sleep apnea on cognition in schizophrenia, however, are not well understood. We estimated the prevalence of OSA in a previously characterized sample of 3942 Veterans with schizophrenia by self-report and with a predictive model to identify individuals at high risk for OSA. We then compared neuropsychological and functional capacity assessment results between those who reported OSA versus those who did not, and between those predicted to have OSA versus predicted to not have OSA. We expected that many Veterans not reporting sleep apnea would be predicted to have it, and that both reported and predicted sleep apnea would be associated with lower cognitive and functional performance. The reported prevalence of OSA in the sample was 14%, whereas 72% were predicted to be at high risk of OSA. Interestingly, participants who reported having OSA had better cognitive and functional capacity performance (p's < 0.001) compared to those who did not report OSA, particularly on speed of processing assessments (p < 0.001). Predicted OSA, by contrast, was associated with lower speed of processing, verbal learning and working memory test scores (p's < 0.001). One possible interpretation of these results is that people with higher cognitive capacity may be more likely to seek medical care, while those with cognitive impairments are at greater risk for having untreated co-occurring medical conditions that further compromise cognition.

Is Spirometry a Sufficient Test for Assessing Respiratory Function after Lung Resection?

The prediction of postoperative functional status in non-small cell lung cancer patients based on preoperative assessment of physical and respiratory capacity is inadequate based on recent RCTs. Prospectively collected spirometry data and the six-minute walk test results of 57 patients treated with lobectomy for non-small cell lung cancer were analyzed. The tests were performed before surgery, and 30 and 90 days after lobectomy. All patients underwent a respiratory functional and physical capacity assessment. All 57 patients underwent lobectomy. Before surgery, mean FEV1 was 2.4 ± 0.7 L, corresponding to %FEV1 of 88.3 ± 17.3%. The mean absolute and expected 6MWT distance was 548 ± 74.6 m and 108.9 ± 14.5%, respectively. At the first postoperative evaluation 30 days after surgery, FEV1 and %FEV1 decreased significantly by an average of 0.5 ± 0.3 L and 15.1 ± 10.7%, while 6MWT and expected 6MWT decreased minimally by an average of 1.0 m and 0.8%, respectively. Three months after lobectomy, FEV1 and %FEV1, compared with the initial assessment, decreased by an average of 0.3 ± 0.3 l and 7.8 ± 10.0%, while 6MWT and its expected score increased to 564.6 ± 84.6 m and 112.8 ± 15.8%, respectively. After lobectomy, FEV1 decreased slightly and less than expected, while 6MWT increased proportionally compared to the preoperative evaluation.

Evaluation of frailty in geriatric patients undergoing cardiac rehabilitation after cardiac procedure: results of a prospective, cross-sectional study

BackgroundFrailty is an indicator of a decline in quality of life and functional capacity in cardiac rehabilitation (CR) patients. Currently, there is no standardized assessment tool for frailty used in CR. The aim of this study was to determine if the Clinical Frailty Scale (CFS) is feasible for assessing frailty in CR.MethodsProspective, cross-sectional study within the framework of the ongoing multicenter prehabilitation study "PRECOVERY". Patients ≥75 years undergoing CR after cardiac procedure (n=122) were recruited in four German inpatient CR facilities. Assessments included: CFS, Katz-Index, hand grip strength (HGS), Short Physical Performance Battery (SPPB) and six-minute-walk test (6MWT). Outcomes were frailty (CFS≥4) and the correlation of frailty with assessments of functional capacity, activities of daily living and clinical parameters. Statistical analysis included descriptive statistics and correlations, using the spearman correlation coefficient and chi-square test to test for significance.ResultsData from 101 patients (79.9±4.0 years; 63% male) were analyzed. The mean CFS score was 3.2±1.4; 41.6% were defined as frail (CFS≥4). The mean time required to assess the CFS was 0.20 minutes. The findings show that CFS correlates significantly (p<0.001) with the following factors: Katz-Index, HGS, SPPB-Score and 6MWT (r≤-0.575). In addition, CFS correlated with small to moderate effects with co-morbidities (r=0.250), as-needed medications and need for nursing assistance (r≤0.248).ConclusionsThe CFS assessment can be performed in under one minute and it correlates significantly with assessments of functional capacity, activities of daily living and clinical parameters in the CR setting.Trial registrationGerman Clinical Trials Register (DRKS; http:// www. drks. de; DRKS00032256). Retrospectively registered on 13 July 2023.

Physical functional capacity assessment in children with chronic kidney disease: A cross sectional observational study.

Chronic kidney disease (CKD) leads to reduced muscle mass and strength in children resulting in a decrease in functional capacity. The objectives of this cross-sectional observational study were to evaluate and compare the functional capacity and muscle strength in children with CKD stage I - V (group A), on dialysis (stage VD) (group B), and kidney transplant recipients (KTR) (group C) in Indian children. 60 children, 20 each in groups A, B, and C were enrolled. Children who could not do the tests and transplant recipients within 6 months of transplantation were excluded. Functional capacity and muscle strength were assessed by 6-minute walk distance (SMWD), timed floor-to-stand test (TFTS), and hand grip strength (HGS). The mean age of the group was 12.54 ± 2.96 years. Among groups A, B, and C, the SMWD in meters (465.90 ± 68.85, 381.45 ± 50.88, 509.05 ± 43.37), TFTS in seconds (9.93 ± 1.77, 10.36 ± 1.30, and 7.68 ± 0.76), and HGS in kg were (12.7 ± 3.85, 10.4 ± 3.02, 19.75 ± 4.45), respectively (p &lt; 0.001). Group C had the best physical functional capacity. The SMWD and HGS had a moderate positive correlation (r = 0.658, 0.658, respectively), and TFTS had a negative correlation (r = -0.605) with estimated glomerular filtration rate (eGFR). The mean HGS and TFTS were different between groups A, C, and B, C (p < 0.05) and not between A and B. The SMWT was however different between A, B, and C (p < 0.001). Muscle strength and functional capacity were most impaired in Indian children on hemodialysis and best preserved in KTR.

Accuracy of the 6-Minute Walk Test for Assessing Functional Capacity in Patients With Heart Failure With Preserved Ejection Fraction and Other Chronic Cardiac Pathologies: Results of the ExIC-FEp Trial and a Meta-Analysis

BackgroundHeart diseases, particularly heart failure, significantly impact patient quality of life and mortality rates. Functional capacity assessment is vital for predicting prognosis and risk in these patients. While the cardiopulmonary exercise test is considered the gold standard, the 6-minute walk test has emerged as a more accessible alternative. However, the screening accuracy and optimal cut-off points of the 6-minute walk test for detecting severely reduced functional capacity in cardiac pathologies, including heart failure with preserved ejection fraction, are unclear. The study aimed to analyse the diagnostic accuracy of the 6-minute walk test for detecting reduced functional capacity, defined as VO2max < 14 ml/kg/min, compared with the cardiopulmonary exercise test in participants with heart failure with preserved ejection fraction using data from the “Ejercicio en Insuficiencia Cardiaca con Fracción de Eyección Preservada” (ExIC-FEp) trial; and to compare these results with previous studies investigating the screening accuracy for assessing functional capacity of the 6-minute walk test in participants with other chronic cardiac pathologies through a meta-analysis.ResultsThe ExIC-FEp trial involved 22 participants with heart failure with preserved ejection fraction, who were not treated with beta-blockers, using the cardiopulmonary exercise test, specifically VO2max, as the reference test. The 6-minute walk test had a sensitivity of 70%, a specificity of 80%, and an area under the curve of 76% in the ExIC-FEp trial. Five studies were included in the meta-analysis showing a sensitivity of 79%, a specificity of 78%, and an area under the curve of 85%.ConclusionIn conclusion, the 6-minute walk test holds promise as a screening tool for assessing functional capacity in heart failure with preserved ejection fraction and chronic heart diseases, with a VO2max < 14 ml/kg/min as a reference point. It demonstrates moderate to good screening accuracy. However, the screening accuracy and optimal cut-off points of the 6-minute walk test for detecting severely reduced functional capacity, regardless of aetiology, are unclear.Trial RegistrationNCT05726474. Registered 16 February 2023, https://clinicaltrials.gov/study/NCT05726474.

Investigating the relationship between minute ventilation and metabolic contribution in long COVID: A retrospective cohort study utilizing cardiopulmonary exercise testing

Long COVID (LC) presents as a complex and debilitating condition characterized by persistent, episodic symptoms that significantly impact individuals' quality of life and functional capabilities (Brown et al., 2021, BMJ Glob Health, 6). There are several hypotheses for the underlying pathophysiology and mechanisms of long COVIDs nature. This study aims to explore the association between minute ventilation and metabolic contribution in individuals experiencing long-term COVID-19 symptoms. Utilising cardiopulmonary exercise testing (CPET), acknowledged as precise, non-invasive prognostic tools, to evaluate cardio-respiratory response to incremental exercise, aiding in the assessment of impaired cardio-respiratory function and perfusion. A cohort observation study was conducted, involving patients with confirmed COVID-19 diagnoses and persistent symptoms three months post-infection, aged between 18 to 65 years. Patients undergo three visits at the university: a baseline assessment, followed by two sessions involving the CPET, spaced 24 hours apart. The baseline visit includes gathering anthropometric data, lung function tests (MIP/MEP), questionnaires, symptom profiling and functional capacity assessments (6MWT and TUG). Data from these assessments determine CPET starting loads based on three stratas: Strata I (6MWD &lt; 350 m, starting load of 10 W), Strata II (6MWD 350-400 m, starting load of 20 W), and Strata III (6MWD &gt; 400 m, starting load of 30 W). Subsequent sub-maximal CPET sessions are conducted to test integrated physiological responses to exercise while preventing PEM/PESE. Measurements include pulmonary gas exchange, ventilation, ventilatory thresholds, and blood profiling. Analysis at present is ongoing. No adverse events or serious adverse events occurred during data collection. Results from this investigation provide insights into the physiological mechanisms underlying long COVID and contribute to the development of tailored management strategies for affected individuals. CPET is the gold standard for assessing cardiorespiratory fitness (CRF) and is vital for understanding LC treatment (Faghy et al., 2024, Prog Card Disease). The use of 2-day CPET methods are increasingly used to identify aerobic deficits and physiological deficits in chronic diseases like ME/CFS and LC. Despite risks, CPET measurements offer insight into pulmonary-vascular function and CRF impairment post-COVID-19 infection (Faghy et al., 2020, Brit J Anaes, 125, 447-449).

An observational study to evaluate the within-day reliability and concurrent validity of 2-minute walk test (2MWT) and 10-metere walk test (10MWT) in health individuals wearing a mask

Background Exercise tests are widely used to prescribe exercises for patients with cardiorespiratory conditions and assess impact of treatments. The 2-minute walk test (2MWT) and 10-metre walk test (10MWT) are common assessments of functional exercise capacity. The COVID-19 pandemic resulted in people wearing masks (commonly surgical masks) to reduce infection. However, the validity and reliability of 2MWT and 10MWT wearing a mask is unknown and further research is required. Aim To assess the within-day reliability and concurrent validity of the 2MWT and 10MWT in healthy individuals wearing a surgical mask. Design and Setting Observational study, in a university setting Methods All participants completed three tests of 2MWT and 10MWT wearing a surgical mask (on one day) and one test without a mask (on a separate day) within one week. Oxygen saturation and heart rate were measured using pulse oximetry and the Borg scale assessed dyspnoea. Statistical analyses included: intraclass correlation coefficients (ICC) for within-day reliability of mask-wearing during three tests and Pearson’s coefficient for concurrent validity correlated tests with a surgical mask and without a mask (the gold standard). Results 15 people, mean (standard deviation) age 26 (2) years were included. The 2MWT and 10MWT (with mask) had excellent within-day reliability (ICC =0.823, 0.920 respectively). Both the 2MWT and 10MWT with and without a mask were highly correlated (r = 0.815, 0.943 respectively, p&lt;0.01). Conclusions The results showed excellent within-day reliability and concurrent validity of 2MWT and 10MWT with a surgical mask in healthy individuals. Further research in clinical populations is needed.

WS08.04 Assessment of functional exercise capacity using telehealth: reliability, validity, and usability in children with cystic fibrosis

WS08.04 Assessment of functional exercise capacity using telehealth: reliability, validity, and usability in children with cystic fibrosis

The one-minute sit-to-stand-test performance is associated with health-related quality of life in patients with pulmonary hypertension.

Patients with pulmonary hypertension (PH) have an impaired functional capacity and poor health-related quality of life (HRQoL). The one-minute sit-to-stand test (1-min STST) can be used for the assessment of functional capacity. Our aim was to evaluate the 1-min STST performance and its association with patient-reported HRQoL in patients with PH. We prospectively assessed functional capacity in 98 PH patients (mean age 66 ± 15 years, 55% female) using the 1-min STST. Patients had to stand up and sit down from a chair as many times as possible within one minute. Patients' HRQoL was evaluated with the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) questionnaire, which consists of the three subcategories symptoms, activities and quality of life (QoL). We observed a significant correlation of the 1-min STST performance with all HRQoL subcategories assessed with the CAMPHOR questionnaire: A lower number of 1-min STST repetitions correlated with more symptoms (rs = -.398, p < .001), worse functioning (rs = -.551, p < .001) and a decreased QoL (rs = -.407, p < .001). Furthermore, in the multivariable linear regression analysis, adjusted for age, sex, body mass index (BMI) and mean pulmonary artery pressure (mPAP), lower 1-min STST performance was an independent predictor for worse symptoms (est. β = -0.112, p = .003), activities (est. β = -0.198, p < .001) and QoL (est. β = -0.130, p < .001) assessed with the CAMPHOR questionnaire. Our results indicate that regardless of age, sex, BMI and mPAP the 1-min STST performance is associated with all CAMPHOR HRQoL subcategories in patients with PH. Therefore, the 1-min STST performance might be a new option to assess functional capacity correlated to HRQoL in patients with PH.

Unsophisticated assessment of the cardiopulmonary function in patients with pectus excavatum using the six minute walk test

Background We explored whether the maximum predicted walking distance, assessed with six-minute walk test (6MWT) and reflecting submaximal functional exercise capacity, is decreased among patients with pectus excavatum (PEX). Methods This study comprised a retrospective analysis of patients with PEX who underwent a 6MWT for the assessment of functional capacity. The maximum distance walked was recorded and compared to reference values established for different populations, including a young and healthy South American population. Results We included 43 patients with PEX who underwent 6MWT. The mean age was 17.8 ± 6.7 years. The mean maximum distance walked was significantly lower than the predicted distance (600.8 ± 67.6 metres vs. 729.8 ± 67.5 metres, p < 0.0001). Using the Enright reference equation including an older reference population, the mean negative difference was higher (PEX patients walked 190.4 ± 78.4 metres less than predicted, p < 0.0001). We also applied the Li et al. reference equation accounting for sex among other variables, detecting a decreased walked distance compared to the gender-adjusted predicted distance (PEX patients walked a mean 222.4 ± 87.4 metres less than predicted, p < 0.0001). Using the Ulrich et al. equation, PEX patients walked a mean 114.2 ± 85.1 metres less than predicted (p < 0.0001). Although of uncertain clinical relevance, there was a significant decrease in the mean oxygen saturation after exercise (baseline 97.4 ± 1.2%, vs. final 96.4 ± 2.1%, p = 0.006). Conclusions In this study, we identified a significant reduction in the maximum walked distance among patients with PEX compared to the predicted distance, thus potentially emerging as an unsophisticated means to evaluate and quantify functional exercise capacity.

Assessment of Nutritional Status And Functional Capacity of Rural Elderly Population In Chattogram, Bangladesh

Background: Bangladesh, like many developing countries, is experiencing population ageing. There is inadequate information regarding the prevalence of malnutrition and functional dependency in community-living rural senior residents in this country. The study aims to determine the nutritional status and functional capacity of the rural elderly population of Chattogram District of Bangladesh and to search for its associated factors. Methods: This community-based cross-sectional study included 213 subjects aged 60 years and over from two Upazilla of Chattogram district by a multistage random sampling technique. Sociodemographic and clinical data were collected using a structured questionnaire, nutritional status was assessed with the Mini Nutritional Assessment-Short Form (MNASF) tool and functional assessment was done using the Modified Barthel self-care index (BSI).Results: The participants’ mean age was 66.1 ± 6.5 years and 51.6 % was female. More than half of the participants (45.4%) were illiterate. The majority of them were living in a joint family with their spouse. About 70% of the participants were from lower socioeconomic classes, 82.2% were not engaged in any vocational activity, 74.6% were entirely dependent economically on others, and 110 (51.6%) had multi- morbidity. The prevalence of malnutrition and risk of malnutrition were 29.9% and 56.8% of the study sample, respectively. About 44% of the participants need help to perform their daily activities. Poor nutritional status was significantly more frequent in elderly subjects aged more than 70 years, in respondents living without a partner, and in older people with multi-morbidity. Conclusion: Poor nutritional status was commonly observed among older adults living in rural areas in Chattogram. The associated factors should be further considered for targeting particularly vulnerable individuals. Bangladesh J Medicine 2024; 35: 76-81

Assessing the Effect of Data Quality on Distance Estimation in Smartphone-Based Outdoor 6MWT.

As a result of technological advancements, functional capacity assessments, such as the 6-minute walk test, can be performed remotely, at home and in the community. Current studies, however, tend to overlook the crucial aspect of data quality, often limiting their focus to idealised scenarios. Challenging conditions may arise when performing a test given the risk of collecting poor-quality GNSS signal, which can undermine the reliability of the results. This work shows the impact of applying filtering rules to avoid noisy samples in common algorithms that compute the walked distance from positioning data. Then, based on signal features, we assess the reliability of the distance estimation using logistic regression from the following two perspectives: error-based analysis, which relates to the estimated distance error, and user-based analysis, which distinguishes conventional from unconventional tests based on users' previous annotations. We highlight the impact of features associated with walked path irregularity and direction changes to establish data quality. We evaluate features within a binary classification task and reach an F1-score of 0.93 and an area under the curve of 0.97 for the user-based classification. Identifying unreliable tests is helpful to clinicians, who receive the recorded test results accompanied by quality assessments, and to patients, who can be given the opportunity to repeat tests classified as not following the instructions.

Intravesical Interferon Therapy vs Hyaluronic Acid for Pain Among Female Individuals With Interstitial Cystitis

Interstitial cystitis (IC) is a debilitating condition. Although viral infection is a potential etiological cause, few studies have detected the effect of antiviral treatment. To determine the efficacy and safety of intravesical interferon instillation compared with hyaluronic acid in female patients with IC. This double-masked, randomized phase 2/3 clinical trial with parallel group design was implemented from October 2022 to April 2023 and had a 6-month follow-up period. The study was conducted at a single center. Eligible participants were female patients aged 18 to 70 years with a diagnosis of IC for more than 6 months. The last visit took place in October 2023. Data were analyzed between October and November 2023. Patients were randomized 1:1 to receive either intravesical instillation of interferon or hyaluronic acid. The primary end point was change in visual analog scale pain score. Secondary end points included changes in voiding frequency, functional bladder capacity, symptom index, and global response assessment. Adverse events were closely monitored. Among the 52 patients, the mean (SD) age was 50.0 (14.1) years and they were randomized to either the interferon group (26 [50%]) or hyaluronic acid (26 [50%]). The visual analog pain score showed the interferon group decreased more significantly than hyaluronic acid (-1.3; 95% CI, -2.3 to -0.3; P = .02) at month 6, with 20 patients (77%) exhibiting a 30% or higher reduction in pain compared with baseline. Secondary end points of voiding frequency, functional bladder capacity, and nocturia episodes showed no significant difference between 2 therapies. However, interferon showed a significantly higher reduction in the Interstitial Cystitis Symptom Index (-3.0; 95% CI, -5.3 to -0.7; P = .01) and the Problem Index (-2.5; 95% CI, -4.5 to -0.4; P = .02) at month 6, with 22 patients (85%) presenting as moderately or markedly improved. The frequencies of adverse events were similar between 2 groups. Only 1 patient discontinued hyaluronic acid because of poor effectiveness. In this randomized clinical trial, female patients with IC could benefit from intravesical interferon therapy, without serious adverse events. These results offered hope for antiviral approaches in IC, but larger-scale, multicenter trials and long-term follow-up should be considered. ClinicalTrials.gov Identifier: NCT05912946.

Preliminary data from the CONNEX-X extension trial examining the long-term safety of iclepertin in patients with schizophrenia who completed Phase III CONNEX trials

IntroductionCognitive impairment associated with schizophrenia (CIAS) is an important unmet need as there are no effective treatments available. Iclepertin (BI 425809), a glycine transporter-1 inhibitor, has been shown to improve CIAS in Phase II trials, and Phase III trials are underway.ObjectivesThe ongoing CONNEX-X extension study aims to collect additional safety data relating to iclepertin treatment in patients with CIAS.MethodsCONNEX-X (NCT05211947/1346-0014) is a multinational, multicentre, open-label, single-arm extension study in patients with CIAS who completed 26 weeks of treatment (iclepertin 10 mg or placebo) in one of 3 Phase III CONNEX parent trials (NCT04846868/1346-0011, NCT04846881/1346-0012, NCT04860830/1346-0013). An estimated 1400 clinically stable outpatients will be treated (iclepertin 10 mg daily) for 1 year, irrespective of previous treatment (iclepertin/placebo). Patients are excluded if any of the following circumstances occur during the parent study and up to Visit 1 of CONNEX-X: suicidal behaviour or ideation (type 5 on the Columbia-Suicide Severity Rating Scale), diagnosis with moderate/severe substance use disorder, diagnosis other than schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition), development of any condition preventing participation, a haemoglobin level decrease (&gt;25% or &lt;100g/L from baseline in parent trial) or haemoglobinopathies. The primary endpoint is the occurrence of treatment-emergent adverse events. The secondary endpoints include change from baseline (CfB) in Clinical Global Impressions-Severity (CGI-S) and CfB in haemoglobin. Further efficacy endpoints include CfB in MATRICS Consensus Cognitive Battery (MCCB) overall composite T-score, CfB in Schizophrenia Cognition Rating Scale total score and CfB in Virtual Reality Functional Capacity Assessment Tool (VRFCAT) total times.ResultsCurrently, 460 patients have been enrolled and randomised from the parent trials with 0% screening failures (-80% roll-over rate, 30 August 2023). Current study status, including recruitment, screening failures and data collection experiences, are presented.ConclusionsPatient enrolment rates from the CONNEX trials to the CONNEX-X open-label extension study are stable. CONNEX-X will allow the exploration of long-term safety, as well as descriptive analyses of cognitive and functional endpoints of iclepertin in the treatment of CIAS.FundingBoehringer IngelheimDisclosure of InterestC. Reuteman-Fowler Employee of: Boehringer Ingelheim Pharmaceuticals, Inc., Z. Blahova Employee of: Boehringer Ingelheim RCV GmbH &amp; Co. KG, S. Marder Consultant of: Boehringer Ingelheim Pharma GmbH, Merck, Biogen and Sunovion, S. Ikezawa Consultant of: Boehringer Ingelheim Pharma GmbH, Lundbeck, Takeda Pharma, Sumitomo Dainippon Pharma, Employee of: International University of Health and Welfare, Mita Hospital, Tokyo, Japan, P. Falkai Consultant of: Boehringer Ingelheim Pharma GmbH, Boehringer Ingelheim Pharma advisory board

The Phase III CONNEX programme assessing the efficacy and safety of iclepertin in patients with schizophrenia: Trial design and recruitment update

IntroductionIn a 12-week, Phase II (NCT02832037) trial, iclepertin (BI 425809), an inhibitor of glycine transporter-1, was generally well tolerated and significantly improved cognition in 509 patients with schizophrenia.ObjectivesThe Phase III CONNEX programme aims to confirm the efficacy, safety and tolerability of iclepertin in improving cognition and functioning across a larger cohort of patients with schizophrenia.MethodsThe CONNEX programme includes 3 randomised, double-blind, placebo-controlled parallel group trials in patients with schizophrenia (NCT04846868, NCT04846881, NCT04860830) receiving stable antipsychotic treatment. Each trial aims to recruit ˜586 patients, 18–50 years old, treated with 1–2 antipsychotic medications (≥12 weeks on current drug and ≥35 days on current dose before treatment) who have functional impairment in day-to-day activities and interact ≥1 hour per week with a designated study partner. Patients with cognitive impairment due to developmental, neurological or other disorders, with a current DSM-5 diagnosis other than schizophrenia or receiving cognitive remediation therapy within 12 weeks prior to screening, will be excluded. Patients will be recruited from multiple centres across 41 countries in Asia, North and South America, Europe and the Asia-Pacific Region, and randomised 1:1 to receive either iclepertin 10 mg (oral administration; n=293), or placebo (n=293) once daily for 26 weeks. The primary endpoint is change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery. The key secondary endpoints are change from baseline in total score on the Schizophrenia Cognition Rating Scale and change from baseline in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool.ResultsThe CONNEX programme is currently recruiting (Table); the first patients were enrolled in Aug–Sept 2021 and completion is expected in Q1 2025. The presentation will describe the current study status, information relating to screening failures, and the experience of collecting these data as part of a large multi-country, multicentre study.Table.The number of patients recruited by 31 August 2023CONNEX 1CONNEX 2CONNEX 3Screened565521493Randomised409360350Completed trial medication202184191ConclusionsIclepertin may represent the first efficacious medication for cognitive impairment associated with schizophrenia.FundingBoehringer IngelheimDisclosure of InterestC. Reuteman-Fowler Employee of: Boehringer Ingelheim, Z. Blahova Employee of: Boehringer Ingelheim, S. Ikezawa Consultant of: Boehringer Ingelheim Pharma GmbH, Lundbeck, Takeda Pharma, Sumitomo Dainippon Pharma, Employee of: International University of Health and Welfare, Mita Hospital, Tokyo, Japan, S. Marder Consultant of: Boehringer Ingelheim Pharma GmbH, Merck, Biogen and Sunovion, P. Falkai Consultant of: Boehringer Ingelheim Pharma GmbH, Boehringer Ingelheim Pharma Advisory Board, J. H. Krystal Shareolder of: Freedom Biosciences, Inc., Biohaven Pharmaceuticals, Sage Pharmaceuticals, Spring Care, Biohaven Pharmaceuticals Medical Sciences, EpiVario, RBNC Therapeutics, Terran Biosciences and Tempero Bio, Consultant of: Aptinyx, Atai Life Sciences, AstraZeneca Pharmaceuticals, Biogen, Biomedisyn Corporation, Bionomics, Boehringer Ingelheim International, Cadent Therapeutics, Clexio Bioscience, COMPASS Pathways, Concert Pharmaceuticals, Epiodyne, EpiVario, Greenwich Biosciences, Heptares Therapeutics, Janssen, Jazz Pharmaceuticals, Otsuka America Pharmaceutical, Perception Neuroscience Holdings, Spring Care, Sunovion Pharmaceuticals, Takeda Industries, Taisho Pharmaceutical Co.; Biohaven Pharmaceuticals, BioXcel Therapeutics, Cadent Therapeutics, Cerevel Therapeutics, Delix Therapeutics, EpiVario, Eisai, Jazz Pharmaceuticals, Novartis, PsychoGenics, RBNC Therapeutics, Tempero Bio and Terran Biosciences Advisory Boards

Smartphone-based inertial measurements during Chester step test as a predictor of length of hospital stay in abdominopelvic cancer postoperative period: a prospective cohort study

BackgroundObjective assessment of pre-operative functional capacity in cancer patients using the smartphone gyroscope during the Chester step (CST) test may allow greater sensitivity of test results. This study has investigated whether the CST is a postoperative hospital permanence predictor in cancer patients undergoing abdominopelvic surgery through work, VO2MAX and gyroscopic movement analysis.MethodsProspective, quantitative, descriptive and inferential observational cohort study. Fifty-one patients were evaluated using CST in conjunction with a smartphone gyroscope. Multivariate linear regression analysis was used to examine the predictive value of the CST.ResultsThe duration of hospital permanence 30 days after surgery was longer when patients who performed stage 1 showed lower RMS amplitude and higher peak power. The work increased as the test progressed in stage 3. High VO2MAX seemed to be a predictor of hospital permanence in those who completed levels 3 and 4 of the test.ConclusionThe use of the gyroscope was more accurate in detecting mobility changes, which predicted a less favorable result for those who met at level 1 of the CST. VO2MAX was a predictor of prolonged hospitalization from level 3 of the test. The work was less accurate to determine the patient's true functional capacity.