Fatigue Visual Analogue Scale Research Articles

P-1278. Risk Factors Associated with Post-Treatment Lyme Disease Syndrome: A Prospective Cohort Study on Long Island, NY

Abstract Background Lyme disease (LD) is caused by Borrelia burgdorferi transmitted by the Ixodes scapularis tick. Post-treatment Lyme disease syndrome (PTLDS) refers to a condition in which approximately 10-20% of optimally treated LD patients develop persistent symptoms of unknown pathophysiology. The epidemiological data on PTLDS is limited. This study aims to investigate the underlying risk factors associated with PTLDS.Table 1.Patient characteristics in PTLDS developed and PTLDS negative groups and their associated p-values. Methods This is an ongoing prospective cohort study of 47 adult patients with LD (CDC criteria) who were seen at Stony Brook Medicine in NY since 2021. Demographics, and pertinent epidemiological data, including immunocompromised status, coinfection, diagnosis, past medical history and treatment were collected. Twelve symptoms were assessed using the Visual Analogue Score (VAS) and Fatigue Severity Scores (FSS) at initial presentation and 1, 6- and 12-months post-treatment. PTLDS was defined based on at least one symptom present at 6 months. Continuous variables were described using means and standard deviations; categorical variables were described with frequencies and percentages.Table 2.Symptoms reported by patients at 6 months and average Visual Analogue Scale (VAS) scores for each symptom. Results Out of a total of 47 enrolled patients, 44 (female 31%) patients completed their initial VAS. At 6 months, fatigue had the highest frequency (39%). At the initial presentation, median total symptoms scores were 37 for disseminated Lyme (n=14) and 30.5 for erythema migrans (EM) (n=27). Compared to baseline, VAS total symptom scores decreased at 1 month for the disseminated (n=12, median= 6.5) and EM groups (n=25, median= 3.5). VAS total symptom score decreased at 6 months as well for the disseminated (n=10, median= 5.25) and EM groups (n=20, median=3.25). At each visit, the PTLDS group scored higher on the FSS compared to the No PTLDS group, indicating higher levels of fatigue. In both groups, FSS decreased over time.Table 3:Total symptom score at each visit for erythema migrans versus disseminated. P-value calculated comparing LD syndrome disease at each corresponding time point. Conclusion A trend of higher total symptom score was observed in disseminated patients compared to erythema migrans at 6 months post-treatment. Fatigue was the most common symptom reported and the PTLDS group consistently reported higher fatigue severity compared to the No PTLDS group.Table 4:Fatigue Severity Score (FSS) and Visual Analogue Fatigue Scale (VAFS) at each visit for PTLDS and No PTLDS patients. P-value calculated comparing PTLDS and No PTLDS at each corresponding time point. Disclosures All Authors: No reported disclosures

Optimising lighting conditions to enhance seafarer adaptation to the '6-h on/6-h off' shift pattern: a balanced crossover study.

The '6-h on/6-h off' shift pattern could potentially disrupt the physiological rhythms and cognitive performance of seafarers, attributed to its shorter and more frequent shifts. Conversely, light exposure has been demonstrated to enhance cognitive abilities and synchronise physiological processes. Therefore, we studied the fatigue, cognition, sleep and rhythm of seafarers with different shifts to determine how light can benefit their performance. A total of 16 seafarers participated in a 2 × 2 crossover study, which involved two shift types (Morning-Evening and Day-Night) and two lighting conditions (static lighting and dynamic lighting). Sleepiness, cognition and fatigue were assessed every 2 h during '6-h on' period, using the Karolinska Sleepiness Scale, psychomotor vigilance task, critical flicker frequency and visual analogue scale for fatigue. Sleep was monitored during '6-h off' period, core body temperature was continuously tracked for rhythm throughout the shift protocol. For the Day-Night shift, the static mode with stable higher illuminance than dynamic lighting significantly reduced sleepiness (p = 0.01), objective fatigue (p = 0.001), subjective fatigue (fatigue level [p = 0.004] and visual fatigue [p = 0.001]) during the night period, while increasing sleep duration during the day (6:00 a.m. to 12:00 p.m.) and delaying the rhythm. For the Morning-Evening shift, dynamic lighting with lower illuminance significantly increased sleep duration during the night (12:00 a.m. to 6:00 a.m.) without causing a significant difference in performance. Overall, static lighting is more suitable for Day-Night shift seafarers due to lower sleepiness, fatigue and longer daytime sleep duration, while dynamic lighting is more suitable for Morning-Evening shift seafarers due to longer night-time sleep duration. Therefore, different lighting patterns should be adopted for seafarers during different shifts.

Factors associated with quality of life in long-COVID syndrome.

Approximately 10% of patients experience persistent symptoms following COVID-19, known as long-COVID syndrome. This cross-sectional study explored factors of quality of life (QoL) in 53 long-COVID patients. QoL was measured using the World Health Organization-Five Well-Being Index, fatigue with the Fatigue Visual Analogue Scale, and psychological health with the Depression-Anxiety-Stress-21 questionnaire. Six neuropsychological tests assessed information processing speed, verbal memory, visual memory, working memory, attention, language, fluency, recall, and visuospatial function with a composite score calculated by averaging z scores. Patients (76% female, mean age: 54.1 years) were assessed 8.7 months postinfection. Cognitive impairment, present in 49% of the sample, was not associated with QoL. In multiple linear regression, gender, fatigue, and psychological distress accounted for 42% of QoL variance, with fatigue and distress contributing 7% and 11%, respectively. Further studies are needed to determine if fatigue and psychological distress are causally related to QoL in long-COVID and could be treatment targets.

Optimizing oral 3-hydroxybutyrate dosage using pharmacokinetic model to improve cognitive function and mood in healthy subjects.

The brain uses ketones, mainly 3-hydroxybutyrate (3-HB), as an alternative energy source. Therefore, oral intake of 3-HB may help maintain brain health. Previous studies indicated that achieving a maximum concentration (Cmax) of 3-HB in plasma at 0.28 mM could initiate ketone metabolism in the brain; we hypothesized that attaining this Cmax would improve brain health. We aimed to demonstrate the efficacy of an optimized single oral dose of 3-HB on cognitive function and mood through two clinical studies: a pharmacokinetic study and an efficacy study. In the pharmacokinetic study, healthy subjects were ingested 2 and 4 g of 3-HB to construct a compartment model to predict the minimum oral dose of 3-HB needed to achieve the target Cmax. In the efficacy study, a randomized, double-blinded, and placebo-controlled crossover trial, the effects of 3-HB at the predicted doses on cognitive function and mood in healthy subjects were assessed by a serial arithmetic test (SAT), the cognitrax, the profile of mood states 2nd edition (POMS2), and fatigue visual analog scale (VAS). In the pharmacokinetic study, a one-compartment model that includes saturable and non-saturable absorption pathways, constant biosynthesis, and the linear elimination of 3-HB after oral administration were constructed. The model principally reflected the observed serum 3-HB concentrations profiles and predicted a minimum dose of 3.5 g needed to achieve the target Cmax. In the efficacy study, although no significant difference was observed in any cognitive domains assessed by the Cognitrax, total responses and correct answers in the SAT were significantly improved in the active group receiving 3.5 g of 3-HB compared to the placebo group. Regarding the POMS2, confusion-bewilderment, fatigue-inertia, vigor-activity, and total mood disturbance scales were significantly improved in the active group compared to the placebo group. Additionally, fatigue VAS were also significantly improved in the active group compared to the placebo group. We successfully established a one-compartment model for oral 3-HB intake and demonstrated partial efficacy on cognitive function and broad efficacy on mood in healthy subjects with a single oral dose of 3.5 g of 3-HB optimized by the model. https://www.umin.ac.jp/ctr/index-j.htm, identifier [UMIN000042095, UMIN000046666].

Neuroimaging markers of cognitive fatigue in individuals with post-acute sequelae of SARS-CoV-2 infection.

Persistent cognitive fatigue (CF) is the most reported symptom in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), but little is known about its underlying neural basis. This pilot study examined fMRI brain activation patterns during a fatiguing task in those with and without PASC. We hypothesized that individuals with PASC would show changes in CF-related brain activation within fatigue network. Participants were 10 adults with PASC and persistent CF and 10 age- and gender-matched healthy controls. The 2-back working memory task was used during fMRI to induce CF. Patients with PASC reported greater CF, as measured using a Visual Analogue Scale of Fatigue (VAS-F), throughout the task. The relationship of brain activation in the fatigue network to increased CF during the fatiguing task did not differ between groups. There were, however, more areas inside and outside the fatigue network that were activated in the PASC group as reported CF increased. The relationship between brain activation and scores on the 2-back did differ between groups, with the PASC group showing more frontal activation. Findings suggest that individuals with PASC and CF may need to exert greater mental effort during demanding cognitive tasks, reflected in recruitment of a broader network of brain regions.

A Double-Blinded Randomized Controlled Trial: Can Pulsed Electromagnetic Field Therapy Be a Novel Method for Treating Chronic Rhinosinusitis?

Background and Objectives: Pulsed electromagnetic field (PEMF) therapy offers a promising approach to treating inflammatory diseases. Its notable anti-inflammatory and antimicrobial effects and enhancement of microcirculation in the nasal mucosa make it a valuable treatment option. Despite its potential, the use of PEMF for chronic rhinosinusitis (CRS) is still in its early stages, with limited exploration of its effectiveness. This study aimed to assess the impact of PEMF on alleviating symptoms such as fatigue, headaches, sinus opacifications, and ostiomeatal complex issues associated with CRS. Materials and Methods: Forty-seven patients of both genders with CRS, aged 19 to 40 years, were involved in this study. The participants were randomly assigned to either a magnetic or a control group. The magnetic group underwent a 10 min PEMF session with a 20-gauss magnetic field strength at 7 Hz thrice a week for a month. The control group received the same PEMF application as an inactive device. Before and after the intervention, researchers assessed fatigue levels with a visual analog fatigue scale (VAFS), headache intensity via a numerical pain-rating scale, and the status of sinus opacifications and ostiomeatal complex obstructions by computerized tomography (CT). Results: The study findings showed a significant reduction in fatigue and headache scores in the magnetic group compared to the control group (p < 0.05). Additionally, there was a notable improvement in sinus opacifications and ostiomeatal complex obstructions among participants who received PEMF therapy. Conclusions: PEMF therapy effectively reduces fatigue, headaches, and sinus opacifications in CRS patients, suggesting its potential for inclusion in CRS management guidelines to improve patient outcomes and quality of life. The results of this study indicate that PEMF represents a noninvasive and cost-effective approach for treating adults with mild-to-moderate CRS.

The Association Between Patient-Reported Disease Burden and Treatment Switching in Patients with Plaque Psoriasis Treated with Nonbiologic Systemic Therapy.

This real-world study investigated the impact of patient-reported disease burden and health-related quality of life (HRQoL) on switching from systemic nonbiologic to biologic therapy in patients with plaque psoriasis. Biologic therapy-naive (biologic-naive) patients aged ≥18 years who were using systemic nonbiologic treatment and who enrolled in the CorEvitas Psoriasis Registry between April 2015 and August 2022 were included. Measures of patient-reported disease burden and HRQoL were collected at Registry enrollment. The primary outcome of interest was initiation of biologic therapy within 45 days of enrollment. Multivariable logistic regression models were fitted separately for each patient-reported measure, adjusting for patient, disease, and treatment characteristics, including physician-rated disease severity. Adjusted odds ratios of switching to biologic therapy were estimated for greater versus lesser burden for each measure. Of 848 included patients, 323 (38.1%) switched to biologic treatment. Greater patient-reported burden was independently associated with switching, with significantly higher adjusted odds ratios (95% confidence interval) for greater versus lesser burden as measured by the Dermatology Life Quality Index (1.55 [1.08-2.23], P=0.017), visual analog scale (VAS) for itch (2.14 [1.49-3.08], P<0.001), VAS for skin pain (2.18 [1.45-3.29], P<0.001), VAS for fatigue (1.66 [1.15-2.40], P=0.007), Patient Global Assessment-VAS (3.09 [1.94-4.91], P<0.001), and with activities impairment on the Work Productivity and Activity Impairment questionnaire (2.51 [1.72-3.65], P<0.001). In addition to clinically assessed disease severity, patient-reported disease burden and quality of life may drive the switch to biologic treatment in real-world patients with plaque psoriasis.

Prognostic value of patient-reported outcomes in advanced or metastatic melanoma patients treated with immunotherapy: Findings from the CheckMate-067 study

ObjectivePatient-reported outcomes (PROs) that predict survival in cancer patients have yet to be realized as practical tools for clinicians to make better treatment decisions. To identify such PROs in adults with advanced melanoma treated with immunotherapy, this study used 7.5-year follow-up data from CheckMate-067, a phase 3, randomized, double-blind study of nivolumab or nivolumab plus ipilimumab versus ipilimumab. MethodsPRO data assessed using the European Organization of Research for the Treatment of Cancer Core-30 and EQ-5D-3L at baseline and during subsequent visits after treatment initiation were pooled across treatment arms. Associations between baseline PRO or change from baseline (CFB) scores with survival outcomes (progression-free survival [PFS], overall survival [OS], and melanoma-specific survival [MSS]) were examined using Cox proportional hazards models for PFS or OS and cause-specific hazard models for MSS. ResultsBaseline and CFB scores for most PRO domains, especially for physical functioning, global health status/quality of life (GHS/QoL), fatigue, and EQ-5D visual analog scale (VAS), were prognostic of all survival outcomes. Achieving meaningful improvement/maintenance of baseline PRO scores at 12 weeks following treatment initiation predicted better survival outcomes than with meaningful worsening from baseline. ConclusionsPROs at baseline and during treatment, particularly for physical functioning, GHS/QoL, fatigue, and EQ-VAS, were prognostic of survival outcomes. This knowledge may accelerate development of prognostic tools to manage treatment in patients with previously untreated unresectable or metastatic melanoma who undergo immunotherapy.

Impact of Effort Reward Imbalance and Fatigue on General Self Efficacy of Nurses Working in Tertiary Care Hospitals

The study aims to investigate the impact of effort-reward imbalance and fatigue on the self-efficacy of nurses working in tertiary care hospitals. A purposive sampling strategy was used to recruit participants from both the public and private sector hospitals. The sample consisted of (N=91) participants with a mean age of 27 years. Effort Reward Imbalance (ERI-16 item condensed version) scale, along with the Visual Analog Fatigue Scale and General Self-Efficacy tool was used to measure the relationship among these variables. Results showed that there was a significant relationship between fatigue and self-efficacy of nurses. However, age, effort-reward imbalance, and fatigue were the significant predictors of self-efficacy. Married nurses reflected satisfactory levels of self-efficacy as compared to unmarried nurses. Considering the limited resources for data collection, it is advised to consider a collaboration between hospitals and the research committee. Further, there is a need to conduct a longitudinal study followed by interviews to explore personnel reflection among participants.

Money versus performance feedback: money associated with lower feelings of cognitive fatigue

ABSTRACT Objective Prior research suggests that effort and reward are central to cognitive fatigue. To better understand the influence of reward on cognitive fatigue, this study examined the effect of reward type and frequency on cognitive fatigue. Participants and Methods In an online between-subjects study, 400 participants completed a computerized switching task and were randomly sorted into one of the five possible groups based on reward condition: [1] infrequent money, [2] frequent money, [3] infrequent performance-feedback, [4] frequent performance feedback, and [5] no-reward. Cognitive fatigue was assessed using the Visual Analog Scale for Fatigue (VAS-F) during the task. Mixed effects models were used to estimate the influence of reward type and frequency on task performance and cognitive fatigue. Results We found that participants in the monetary groups were significantly faster (p < .001) compared to participants in the feedback and no-reward groups. We also found that participants in the frequent-money group were significantly faster than those in the infrequent-money group (p < .001). We found that the group receiving infrequent-money was associated with a decrease in VAS-F scores compared to no-reward (p = .04). Conclusions The current study supports the role of reward in cognitive fatigue. Our results confirm well-established findings that money positively influences on-task behavior, especially when money is provided frequently. In a cognitively healthy sample, there is some evidence to suggest that money provided infrequently could decrease feelings of fatigue. Continued work is needed to understand how, and which, specific behavioral reward manipulations reduce fatigue, especially in clinical populations most affected by fatigue.

Dose-effect relationship of moxibustion for rheumatoid arthritis of liver and kidney deficiency and its effect on fatigue: a randomized controlled trial

To observe the effects of moxibustion with different frequency on the disease activity and fatigue of rheumatoid arthritis (RA) with liver and kidney deficiency on the basis of western medication treatment. A total of 135 RA patients with liver and kidney deficiency were randomly divided into a high-frequency moxibustion group (45 cases, 3 cases dropped out), a low-frequency moxibustion group (45 cases, 2 cases dropped out) and a western medication group (45 cases, 2 cases dropped out, 1 case discontinued). Leflunomide tablet was taken orally in the western medication group, once a day, 20 mg a time. On the basis of the treatment in the western medication group, moxibustion was applied at ashi points and bilateral Shenshu (BL 23) and Sanyinjiao (SP 6) in the two moxibustion groups, 15 min a time. The treatment was given once a day, 5 times a week in the high-frequency moxibustion group and once every other day, 3 times a week in the low-frequency moxibustion group. A total of 12-week treatment was required in the 3 groups. Before and after treatment, the 28 joint disease activity score (DAS28), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), TCM syndrome score, average grip strength (GS) of both hands, 30-second sit-to-stand (STS), timed up and go (TUG), 20-meter walk test (20MWT), self rating anxiety scale (SAS) score and self rating depression scale (SDS) score were observed; before treatment, after treatment and in follow-up of 1, 3 months after treatment completion, the scores of fatigue visual analogue scale (VAS), Bristol rheumatoid arthritis fatigue numerical rating scale (BRAF-NRS) and Bristol rheumatoid arthritis fatigue multi-dimensional questionnaire (BRAF-MDQ) were observed, and the relieving of disease was evaluated by American College of Rheumatology (ACR)20/50/70 standards in the 3 groups. After treatment, the DAS28 scores, ESR, CRP, RF, TCM syndrome scores, TUG, 20MWT, SAS scores and SDS scores were decreased compared with those before treatment (P<0.01, P<0.05), while the average GS of both hands and STS were increased compared with those before treatment (P<0.01, P<0.05) in the 3 groups. After treatment, in the high-frequency moxibustion group, the DAS28 score, ESR, CRP, TCM syndrome score, SAS score and SDS score were lower (P<0.01, P<0.05), while the average GS of both hands and STS were higher (P<0.01, P<0.05) than those in the low-frequency moxibustion group and the western medication group; the TUG and 20MWT were decreased compared with those in the western medication group (P<0.01, P<0.05). After treatment, in the low-frequency moxibustion group, the DAS28 score, ESR, CRP, TCM syndrome score, TUG, SAS score and SDS score were lower (P<0.05, P<0.01), while the average GS of both hands was higher (P<0.01) than those in the western medication group. In each time point after treatment, the scores of fatigue VAS and BRAF-NRS were decreased compared with those before treatment in the 3 groups (P<0.01), while the BRAF-MDQ scores were decreased compared with those before treatment in the high-frequency moxibustion group and the low-frequency moxibustion group (P<0.01). After treatment, the BRAF-MDQ score was decreased compared with that before treatment in the western medication group (P<0.01). In the high-frequency moxibustion group, the scores of fatigue VAS, BRAF-NRS and BRAF-MDQ of each time point after treatment were lower than those in the western medication group (P<0.01), the scores of fatigue VAS and BRAF-NRS in follow-up of 1 month after treatment completion as well as the BRAF-MDQ score after treatment were lower than those in the low-frequency moxibustion group (P<0.01, P<0.05). In the low-frequency moxibustion group, the scores of fatigue VAS, BRAF-NRS and BRAF-MDQ of each time point after treatment were lower than those in the western medication group (P<0.01, P<0.05). After treatment, the proportions of ACR20 and ACR50 in the high-frequency moxibustion group and the low-frequency moxibustion group were higher than those in the western medication group (P<0.01), the proportion of ACR70 in the high-frequency moxibustion group was higher than those in the low-frequency moxibustion group and the western medication group (P<0.05, P<0.01), and the proportion of ACR70 in the low-frequency moxibustion group was higher than that in the western medication group (P<0.05). On the basis of the western medication treatment, moxibustion can effectively reduce the disease activity and improve fatigue status in RA patients with liver and kidney deficiency, and its efficacy is positively correlated with treatment frequency.

Effects of peanut ball use on perceived labor pain, fatigue, and mother's perception of childbirth: a randomized controlled trial.

The aim of this study was to evaluate the effects of using peanut balls on labor pain, fatigue, and the mother's perception of labor. This is a randomized controlled intervention trial. Data were collected from the Intervention (peanut ball) and Control groups between July 2022 and June 2023, with 45 pregnant women in each group. Data were collected using a personal information form, the Visual Analog Scale-Pain (VAS-P), the Visual Analog Scale for Fatigue (VAS-F), and the Maternal Perception of Childbirth Scale (MPCS). The VAS-P scores of the intervention group were statistically significantly lower than those of the control group 15min after peanut ball application (p = .000). Immediately after and 15min after peanut ball application, the mean fatigue score of the Intervention group was statistically significantly lower than that of the Control group (p = .000). There was no statistically significant difference between the mean duration of labor minutes in the two groups (p = .177). The mean MPCS scores of the intervention group and control groups were 62.73 + 7.30 and 47.17 + 9.12, respectively, and the difference was statistically significant (p = .000). The findings of this study indicate that the use of peanut balls during labor can effectively reduce labor pain and fatigue in pregnant women, without affecting the duration of labor. Additionally, the use of peanut balls has been shown to positively influence the perception of labor among pregnant women. Therefore, it is recommended that midwives educate pregnant women about the use of peanut balls during labor and provide support in their use.

Fatigue in women after percutaneous coronary intervention - results from CONCARDPCI

Abstract Background Better and more efficient treatment have led to decreased mortality rates and shorter hospital stays in patients with coronary artery disease (CAD). Nevertheless, fatigue is a prominent and distressing symptom in patients with CAD more frequently reported in women. Therefore, further investigation through follow-up studies focusing on women and fatigue in the context of CAD is imperative to address this knowledge gap and enhance clinical outcomes. Purpose To investigate fatigue in women with CAD at baseline, 2, 6 and 12 months after percutaneous coronary intervention (PCI), and to determine whether self-reported health, and clinical and sociodemographic characteristics are associated with fatigue after PCI. Methods CONCARDPCI is a multicentre, prospective cohort study including 3417 consecutive patients after PCI. Of these, 22% (n=746) were women and included in this analysis. Clinical data were collected from patients’ medical records and national registries. Sociodemographic characteristics were self-reported at baseline registration. Self-reported health was assessed with RAND-12 Item Short Form Health Survey (RAND-12) and the Myocardial Infarction Dimensional Assessment Scale (MIDAS). Fatigue was measured with a Visual Analogue Fatigue scale providing scores from 0-10 with higher scores indicating higher levels of fatigue. Patient-reported outcomes measures were completed at baseline and 2-, 6- and 12 months after hospital discharge. Results A substantial proportion was living alone (39%), retired (55%) or had three or more comorbidities (67%). Meanage was 68 years (SD 10). Age was significantly associated with fatigue at baseline (p&amp;lt;0.001), 6 months (p=0.002) and 12 months (p&amp;lt;0.001) in the RAND-12 model and at 2 months (p=0.018) and 12 months (p= 0.003) in the MIDAS model. Cohabitation status was significantly associated with fatigue at baseline (p=0.001), 2 months (p=0.033) and 12 months (p=0.016) in the RAND-12 model and at 2 months (p=0.032) in the MIDAS model. The degree of fatigue was at the highest level at baseline (5.2, SD 2.7) but was still present after one year (4.4, SD 2.6) (p≤0.004 for all comparisons). In RAND-12, self-reported physical health was associated with fatigue (p &amp;lt;0.001 for all comparisons). Furthermore, mental health was associated with fatigue at all meassuring time points (p&amp;lt;0.001- p=0.006). In MIDAS, physical health was associated with fatigue (p&amp;lt;0.001 for all comparisons). Conclusion A substantial proportion of women reported challenges with fatigue long after hospital discharge. Therefore, healthcare providers must identify the most vulnerable patients and tailor interventions accordingly. Person-centered treatment strategies may be developed by identifying factors associated with fatigue, such as age, cohabitation status, and self-reported physical and mental health.

Efficacy of treatment with traditional Chinese patent medicine (Fufang E'jiao Syrup) for cancer-related fatigue in patients with advanced cancer: A randomized, double-blinded, placebo-controlled, multicenter trial.

12053 Background: There is ongoing interest in finding effective drugs for cancer-related fatigue (CRF) in advanced cancer patients, although studies have had mixed results. Fufang E'jiao Syrup (FFEJS), a traditional Chinese patent medicine, has shown promise in alleviating CRF. This trial aims to investigate whether FFEJS could reduce fatigue and improve quality of life in advanced cancer patients. Methods: This prospective, multicenter, double-blinded, placebo-controlled trial was implemented at 29 hospitals in China, enrolling 611 advanced non-small cell lung cancer, colorectal cancer, and gastric cancer patients with Visual Analogue Scale for Fatigue ≥ 4 points. The study was conducted between September 23, 2019 and April 7, 2022, with a final follow-up on May 25, 2022. Participants were randomized to receive FFEJS (20 ml, 3 times per day) or a matching placebo orally for six weeks. The safety assessments were extended until the fourth week after the trial ended. The primary outcome was the change in total mean score (range: 0 [no fatigue] to 10 [extreme fatigue] points) on the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV) from baseline to week 6. Secondary outcomes include quality of life (Functional Assessment of Chronic Illness Therapy-Fatigue, FACIT-F) and adverse events. FFEJS were compared with the placebo group using a linear mixed model. Results: Among 611 patients randomized (FFEJS: 303 and placebo: 308; 210 non-small cell lung cancer [34.4%], 201 colorectal cancer [32.9%], 200 gastric cancer [32.7%]; mean [SD] age, 62.8 [9.3] years; 413 [68.3%] man; mean [SD] baseline RPFS-CV total mean score, 4.86 [1.30] points), 503 (82.3%) completed the primary end point. By the end of week 6, the FFEJS group achieved normal fatigue levels (RPFS-CV &lt; 4) compared to the placebo group (FFEJS: 3.78 vs Placebo: 4.39, adjusted mean difference 0.59 points [95% CI, 0.45 to 0.76 points]; P &lt; .001). The adjusted mean difference for a favorable shift to a higher FACIT-F total score at week 6 comparing FFEJS with placebo was 2.77 points (97.36 vs 94.23 points; [95% CI, 0.56-4.96 points]; P = .02). There was no difference in adverse events occurrence between FFEJS and the placebo groups (110 [20%] vs 122 [18%], P = .38). Conclusions: In this randomized clinical trial among advanced cancer patients with CRF, FFEJS reducedfatigue severity and improved quality of life compared to placebo. Research is needed to assess the mechanism, clinical effect, and long-term safety of FFEJS for CRF in advanced cancer patients. Clinical trial information: NCT04147312 .

A phase II randomized, double-blind, placebo-controlled study of Nuvastatic (C50SEW505OESA), a standardized rosmarinic acid-rich polymolecular botanical extract formulation to reduce cancer-related fatigue in patients with solid tumors.

We evaluated the efficacy and safety of Nuvastatic™ (C5OSEW5050ESA)in improving cancer-related fatigue (CRF) among cancer patients. This multicenter randomized double-blind placebo-controlled phase 2 trial included 110 solid malignant tumor patients (stage II-IV) undergoing chemotherapy. They were randomly selected and provided oral Nuvastatic™ 1000mg (N = 56) or placebo (N = 54) thrice daily for 9weeks. The primary outcomes were fatigue (Brief Fatigue Inventory (BFI)) and Visual Analog Scale for Fatigue (VAS-F)) scores measured before and after intervention at baseline and weeks 3, 6, and 9. The secondary outcomes were mean group difference in the vitality subscale of the Medical Outcome Scale Short Form-36 (SF-36) and urinary F2-isoprostane concentration (an oxidative stress biomarker), Eastern Cooperative Oncology Group scores, adverse events, and biochemical and hematologic parameters. Analysis was performed by intention-to-treat (ITT). Primary and secondary outcomes were assessed by two-way repeated-measures analysis of variance (mixed ANOVA). The Nuvastatic™ group exhibited an overall decreased fatigue score compared with the placebo group. Compared with the placebo group, the Nuvastatic™ group significantly reduced BFI-fatigue (BFI fatigue score, F (1.4, 147) = 16.554, p < 0.001, partial η2 = 0.333). The Nuvastatic™ group significantly reduced VAS-F fatigue (F (2, 210) = 9.534, p < 0.001, partial η2 = 0.083), improved quality of life (QoL) (F (1.2, 127.48) = 34.07, p < 0.001, partial η2 = 0.243), and lowered urinary F2-IsoP concentrations (mean difference (95% CI) = 55.57 (24.84, 86.30)), t (55) = 3.624, p < 0.001, Cohen's d (95% CI) = 0.48 (0.20, 0.75)). Reported adverse events were vomiting (0.9%), fever (5.4%), and headache (2.7%). Nuvastatic™ is potentially an effective adjuvant for CRF management in solid tumor patients and worthy of further investigation in larger trials. ClinicalTrial.gov ID: NCT04546607. Study registration date (first submitted): 11-05-2020.

Are central and systemic inflammation associated with fatigue in cerebral small vessel disease?

Fatigue is a common symptom in cerebral small vessel disease (SVD), but its pathogenesis is poorly understood. It has been suggested that inflammation may play a role. We determined whether central (neuro) inflammation and peripheral inflammation were associated with fatigue in SVD. Notably, 36 patients with moderate-to-severe SVD underwent neuropsychometric testing, combined positron emission tomography and magnetic resonance imaging (PET-MRI) scan, and blood draw for the analysis of inflammatory blood biomarkers. Microglial signal was taken as a proxy for neuroinflammation, assessed with radioligand 11C-PK11195. Of these, 30 subjects had full PET datasets for analysis. We assessed global 11C-PK11195 binding and hotspots of 11C-PK11195 binding in the normal-appearing white matter, lesioned tissue, and combined total white matter. Peripheral inflammation was assessed with serum C-reactive protein (CRP) and using the Olink cardiovascular III proteomic panel comprising 92 biomarkers of cardiovascular inflammation and endothelial activation. Fatigue was assessed using the fatigue severity scale (FSS), the visual analog fatigue scale, and a subscale of the Geriatric Depression Scale. Mean (SD) age was 68.7 (11.2) years, and 63.9% were male. Of these, 55.6% showed fatigue on the FSS. Fatigued participants had higher disability scores (p = 0.02), higher total GDS scores (p = 0.02), and more commonly reported a history of depression (p = 0.04). 11C-PK11195 ligand binding in the white matter was not associated with any measure of fatigue. Serum CRP was significantly associated with average fatigue score on FSS (ρ = 0.48, p = 0.004); this association persisted when controlling for age, sex, disability score, and depression (β = 0.49, 95% CI (0.17, 2.26), p = 0.03). Blood biomarkers from the Olink panel showed no association with fatigue. In symptomatic SVD patients, neuroinflammation, assessed with microglial marker 11C-PK11195, was not associated with fatigue. We found some evidence for a role of systematic inflammation, evidenced by an association between fatigue severity and raised CRP, but further studies are required to understand this relationship and inform whether it could be therapeutically modified to reduce fatigue severity. Data for this study are available from the corresponding author upon reasonable request.

Validating the Fatigue Scale for Motor and Cognitive Function (FSMC) in chronic stroke.

Post-stroke fatigue can manifest as both physical and mental fatigue. The Fatigue Scale for Motor and Cognitive Functions (FSMC) evaluates fatigue on the motor and cognitive domains separately, however, the psychometric properties of this measure in stroke have not been reported. To determine the internal consistency, test-retest reliability, and concurrent validity of the FSMC in chronic stroke. Thirty-four participants with chronic stroke (55.26±12.27 years of age; 59.53±89.21 months post-stroke) completed the FSMC on two separate visits. Internal consistency and reliability of the FSMC were examined using Cronbach's alpha and two-way mixed effects intraclass correlation coefficients (ICC), respectively. Correlation between the FSMC and the Fatigue Severity Scale and Visual Analog Scale-Fatigue was used to assess concurrent validity. Internal consistency was excellent (Cronbach's alpha > 0.9) and reliability was moderate to good (ICC = 0.72-0.81) for all FSMC scores. The FSMC demonstrated moderate to good concurrent validity with the Fatigue Severity Scale (ρ= 0.66-0.72) but only fair concurrent validity with the Visual Analog Scale-Fatigue (ρ= 0.37-0.44). The FSMC is a valid and reliable measure of post-stroke fatigue and may be a useful tool to examine physical fatigue and cognitive fatigue in chronic stroke.

Evaluation of Quality of Life and Treatment Satisfaction in Newly Diagnosed Cutaneous T-Cell Lymphoma Patients.

Little is known about the impact of MF on quality of life (QoL) in newly diagnosed patients. To describe the impact of the MF diagnosis on QoL, patient expectations, and treatment satisfaction over the first 6 months after diagnosis. Outcomes of this prospective cohort study of newly diagnosed MF patients conducted between 2020 and 2022 at the Leiden University Medical Center included the Skindex-29, RAND-12 Health Survey, degree of itch, pain, and fatigue (Visual Analogue Scale (VAS)), patient expectations, and Client Satisfaction Questionnaire-8 (CSQ-8), measured at baseline and after six months. A total of 28 patients with MF were included. At baseline, 66% (n = 18) "strongly-totally" expected positive effects of the treatment. At the time of diagnosis, 28% of the patients (n = 8) were moderately to severely affected. There was no statistical change in the Skindex-29 score sum score (20 [10-34] vs. 20 [9-36]; p = 0.81) or in the other three subdomains, the RAND-12 scores, and the VAS itch, pain, and fatigue over time. Treatment satisfaction was high overall. Despite that the newly diagnosed MF patients anticipate a positive treatment effect, few improvements in QoL and symptom reduction were found. These data can be used for adequate expectation management and provide a rationale for further evaluation of treatment regimens in these patients.

Impact of Fatigue on Ergonomic Risk Scores and Foot Kinetics: A Field Study Employing Inertial and In-Shoe Plantar Pressure Measurement Devices.

(1) Background: Occupational fatigue is a primary factor leading to work-related musculoskeletal disorders (WRMSDs). Kinematic and kinetic experimental studies have been able to identify indicators of WRMSD, but research addressing real-world workplace scenarios is lacking. Hence, the authors of this study aimed to assess the influence of physical strain on the Borg CR-10 body map, ergonomic risk scores, and foot pressure in a real-world setting. (2) Methods: Twenty-four participants (seventeen men and seven women) were included in this field study. Inertial measurement units (IMUs) (n = 24) and in-shoe plantar pressure measurements (n = 18) captured the workload of production and office workers at the beginning of their work shift and three hours later, working without any break. In addition to the two 12 min motion capture processes, a Borg CR-10 body map and fatigue visual analog scale (VAS) were applied twice. Kinematic and kinetic data were processed using MATLAB and SPSS software, resulting in scores representing the relative distribution of the Rapid Upper Limb Assessment (RULA) and Computer-Assisted Recording and Long-Term Analysis of Musculoskeletal Load (CUELA), and in-shoe plantar pressure. (3) Results: Significant differences were observed between the two measurement times of physical exertion and fatigue, but not for ergonomic risk scores. Contrary to the hypothesis of the authors, there were no significant differences between the in-shoe plantar pressures. Significant differences were observed between the dominant and non-dominant sides for all kinetic variables. (4) Conclusions: The posture scores of RULA and CUELA and in-shoe plantar pressure side differences were a valuable basis for adapting one-sided requirements in the work process of the workers. Traditional observational methods must be adapted more sensitively to detect kinematic deviations at work. The results of this field study enhance our knowledge about the use and benefits of sensors for ergonomic risk assessments and interventions.

Clinical and Laboratory Characteristics of Fatigue-Dominant Long-COVID Subjects: A Cross-Sectional Study

BackgroundLong COVID is defined by persistent symptoms following COVID-19 infection. Approximately 71% of individuals with long COVID experience ongoing fatigue, postexertional malaise, and cognitive impairments, which share pathological similarities with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This similarity has prompted studies to explore the characteristics of long COVID to gain a better understanding of ME/CFS. To gain insights, we investigated the clinical and laboratory characteristics of individuals with fatigue-dominant long COVID. MethodsWe enrolled 100 subjects (36 males, 64 females) with long COVID who had a higher score than 60 in the modified Korean version of the Chalder Fatigue Scale (mKCFQ11) and higher than 5 in a fatigue-focused visual analogue scale. To investigate fatigue symptoms, the mKCFQ11, the Multidimensional Fatigue Inventory, a visual analogue scale for fatigue and brain fog, along with the Short-Form survey, were employed. We also measured 3 cytokines and cortisol levels for immunological and endocrinological indicators. As a cross-sectional observational study, the data were collected at a single point in time. ResultsThe mean scores on the measurements showed severe fatigue, and these scores were significantly correlated, with no differences based on sex, the post-COVID period, or age. Among the laboratory tests, plasma cortisol levels had a significant negative correlation with fatigue scores and a positive correlation with living quality. The negative correlation between cortisol levels and mKCFQ11 scores appeared to be more specific to mental fatigue than physical, which conflicted with other measurements. ConclusionOur findings provide the first insights into the characteristics of fatigue in individuals with long COVID, particularly in terms of fatigue severity and cortisol levels. These results serve as valuable reference data for clinicians dealing with fatigue symptoms in long-COVID patients and for researchers exploring postviral fatigue symptoms, including ME/CFS, in the future.