Significant Improvements In Fatigue Research Articles

Impact of aerobic versus resistive training on functional capacity in acute myeloid leukemia survivors: a comparative study

Background. Cancer-related fatigue is a persistent symptom in acute myeloid leukemia survivors, with associated decreased functional capacity, which further deteriorates their quality of life. The current study aimed to compare between the impact of aerobic training and resistive training on functional capacity in acute myeloid leukemia (AML) survivors. Fifty nine patients with AML from both sexes aged between 35 and 45 years,were selected from hematology department in (BLINDED FOR PEER REVIEW), where the study was conducted. Patients were randomly assigned into two groups; Group (A) underwent aerobic training in the form of cycling within 50-60% of maximum heart rate. Group (B) underwent resistive training conducted in the form of a series of exercises using free weights, and dumbbells. Sessions were carried out three times per week, for a total of eight weeks period. Six minute walk test (6MWT), 10 repetitions maximum test (10 RM). Ventilatory functions test, fatigue severity assessment (FAS) and quality of life (QoL) scales were measured in both groups before and after the study period. Results. Significant improvement in 6MWT, maximum oxygen consumption (VO2 max) and vital capacity in group (A), significant improvement in fatigue and QoL in both groups and significant improvement in 10 RM test in group (B). Conclusion. Both aerobic and resistive training significantly improved functional capacity in acute myeloid leukemia survivors with a more significant improvement due to aerobic training.

The aerobic capacity – fatigue relationship in persons with Multiple Sclerosis is not reproducible in a pooled analysis of two randomized controlled trials

BackgroundFatigue is one of the most frequent symptoms of persons with Multiple Sclerosis (pwMS) but has limited treatment options. Aerobic capacity and endurance training have been discussed as relevant factors to improve fatigue. However, over the last decades, results have been equivocal. This secondary analysis of two pooled parallel group RCTs of three weeks of endurance training (high intensity interval training (HIIT) and moderate continuous training (MCT)) for pwMS aimed to (I) reproduce reported associations between aerobic capacity and fatigue on a cross-sectional and interventional level. The analysis further aimed to (II) investigate intervention effects on fatigue in a severely fatigued subgroup and (III) analyze differences in changes of fatigue between peak oxygen uptake (VO2peak) responders and non-responders. MethodsBoth RCTs were conducted in the same inpatient rehabilitation clinic in Valens, Switzerland. Original primary outcomes were cognitive function (RCT1) and change in proportion of circulating regulatory T-cells (RCT2). PwMS (n = 131) with a relapsing-remitting or secondary progressive MS phenotype and Expanded Disability Status Scale score between 1 - 6.5 were eligible. Over the two studies participants exercised 3 - 5 times per week on cycle ergometers at intensities of 65 - 70% of maximum heart rate (HRmax) for 30 min (MCT groups) or three times per week with five 90 – 180 s intervals at intensities of 85% – 100% of HRmax and 90 s rest intervals (HIIT groups). Main outcome measures for the present secondary analysis were VO2peak measured during a cardiopulmonary exercise test and the Fatigue Scale for Motor and Cognitive Functions (FSMC), both assessed at the start and end of inpatient rehabilitation. ResultsBaseline correlations did not reveal a significant association between VO2peak and FSMC. There were no significant improvements in fatigue after the HIIT and MCT in the overall sample or the subsample of severely fatigued pwMS and no significant differences in fatigue changes between VO2peak-responders and non-responders. ConclusionsOur analysis did not confirm the aerobic capacity - fatigue relationship on a cross-sectional and experimental level, even when analyzing subgroups that should benefit the most according to proposed hypotheses.

Breathing exercises versus strength exercises through telerehabilitation in coronavirus disease 2019 patients in the acute phase: A randomized controlled trial

Objective To compare the effectiveness of two different exercise-based programs through telerehabilitation in patients with coronavirus disease 2019. Design Randomized, controlled, parallel, double-blinded, three-arm clinical trial. Setting Patients’ homes through telerehabilitation devices. Subjects Subjects with coronavirus disease 2019 in the acute phase. Interventions Subjects were divided into three groups: breathing exercises group, strength exercises group or no treatment/control group. Main measures We analysed visual analogue scale for fatigue, 6-minute walking test, 30-seconds sit-to-stand test, multidimensional dyspnoea-12 questionnaire and Borg scale at baseline and 14 days later. Results From 93 subjects recruited, 88 were enrolled, and 77 patients (mean [SD] age 39.40 [11.71]) completed the 14-days intervention and were included in the analysis: 26 in strength exercises group, 29 in breathing exercises group and 22 in control group. The intergroup analysis shows significant differences between the study groups and control group in all variables (p < 0.05); Borg scale, multidimensional dyspnoea-12 questionnaire (pre–post intervention score: strength exercises group: 7.85 [6.82] – 4.54[4.82], breathing exercises group: 11.04 [6.49] – 5.32 [3.63], control group: 10.27 [6.49] – 10.59[6.58]), visual analogue scale for fatigue, 6-minute walking test and 30-seconds sit-to-stand test (pre–post intervention score: strength exercises group: 12.19 [4.42] – 13.58 [5.37], breathing exercises group: 11.18 [3.42] – 12.79 [4.00], control group: 10.45 [2.15] – 9.86[1.88]). The greatest effect sizes were found in the variables Borg Scale (R2 = 0.548) and multidimensional dyspnoea-12 questionnaire (R2 = 0.475). Conclusions Strength exercises group and breathing exercises group obtained significant improvements in fatigue, dyspnoea, perceived effort, and physical state, compared to control group, although the greatest benefits were found for dyspnoea and aerobic capacity in breathing exercises group.

Feasibility and acceptability of using a meditation app in adults with rheumatic disease

ObjectiveMeditation is a stress-reduction and contemplative technique that can improve emotional distress in people with chronic disease and may be especially beneficial for patients with rheumatic diseases. However, patient access to in-person programs is challenging. The goal of this pilot study was to evaluate the feasibility/acceptability associated with physician-directed use of a widely available smartphone application (app), Calm©. MethodsIn this single-arm, pre-post intervention study with recruitment over a 10-month period, adults with rheumatic disease were asked to use the app for ≥5 min/day for 30 days. Participants completed sociodemographic surveys and validated health related quality of life (HRQL) questionnaires from the Patient Reported Outcomes Information System (PROMIS) and NIH Toolbox at baseline and 30-days. ResultsThirty-five participants who were mostly well-educated (66% ≥college degree) females (91%) with a mean age of 50 (SD 13) completed baseline questionnaires; 18 participants completed post-study questionnaires (“full completers”). Full completers had higher baseline stress, anxiety, pain, and patient global assessment scores (p's <0.05) compared to partial completers. Full completers who provided data used the app on average for 283 min/30 days (SD 257; n = 16) and showed significant improvements in fatigue (-7.6 T-Score units, p = 0.017), with trends for improvement in perceived stress, anxiety, sleep disturbance, self-efficacy for managing symptoms, and pain intensity (p's <0.15). ConclusionsA 30-day meditation, stress-reduction app used by patients with rheumatic disease revealed that this is a feasible non-pharmacologic modality to target HRQL and problematic symptoms like fatigue. More rigorous study on app use and potential effect is needed.

Post Hoc Analysis of the Effect of Pegcetacoplan Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria and Baseline Hemoglobin Levels Greater Than 10 Grams per Deciliter

Post Hoc Analysis of the Effect of Pegcetacoplan Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria and Baseline Hemoglobin Levels Greater Than 10 Grams per Deciliter

Fatigue self-management led by occupational therapists and/or physiotherapists for chronic conditions: A systematic review and meta-analysis.

ObjectiveThe aim of this study was to investigate the effectiveness of occupational therapist-/physiotherapist-guided fatigue self-management for individuals with chronic conditions.MethodsEight databases, including MEDLINE and EMBASE, were searched until September 2019 to identify relevant studies. Randomised controlled trials and quasi-experimental studies of self-management interventions specifically developed or delivered by occupational therapists/physiotherapists to improve fatigue symptoms of individuals with chronic conditions were included. A narrative synthesis and meta-analysis were conducted to determine the effectiveness of fatigue self-management.ResultsThirty-eight studies were included, and fatigue self-management approaches led by occupational therapists/physiotherapists were divided into six categories based on the intervention focus: exercise, energy conservation, multimodal programmes, activity pacing, cognitive-behavioural therapy, and comprehensive fatigue management. While all exercise programmes reported significant improvement in fatigue, other categories showed both significant improvement and no improvement in fatigue. Meta-analysis yielded a standardised mean difference of the overall 13 studies: 0.42 (95% confidence interval:−0.62 to − 0.21); standardised mean difference of the seven exercise studies was −0.55 (95% confidence interval: −0.78 to −0.31).DiscussionPhysical exercises inspired by the self-management principles may have positive impacts on fatigue symptoms, quality of life, and other functional abilities.

A Comprehensive Update of the Current Understanding of Chronic Fatigue Syndrome.

This is a comprehensive literature review of chronic fatigue syndrome (CFS). We provide a description of the background, etiology, pathogenesis, diagnosis, and management regarding CFS. CFS is a multifaceted illness that has many symptoms and a wide array of clinical presentations. As of recent, CFS has been merged with myalgic encephalomyelitis (ME). Much of the difficulty in its management has stemmed from a lack of a concrete understanding of its etiology and pathogenesis. There is a potential association between dysfunction of the autoimmune, neuroendocrine, or autonomic nervous systems and the development of CFS. Possible triggering events, such as infections followed by an immune dysregulation resulting have also been proposed. In fact, ME/CFS was first described following Epstein Barr virus (EBV) infections, but it was later determined that it was not always preceded by EBV infection. Patient diagnosed with CFS have shown a noticeably earlier activation of anaerobic metabolism as a source of energy, which is suggestive of impaired oxygen consumption. The differential diagnoses range from tick-borne illnesses to psychiatric disorders to thyroid gland dysfunction. Given the many overlapping symptoms of CFS with other illnesses makes diagnosing it far from an easy task. The Centers for Disease Control and Prevention (CDC) considers it a diagnosing of exclusion, stating that self-reported fatigue for at minimum of six months and four of the following symptoms are necessary for a proper diagnosis: memory problems, sore throat, post-exertion malaise, tender cervical or axillary lymph nodes, myalgia, multi-joint pain, headaches, and troubled sleep. In turn, management of CFS is just as difficult. Treatment ranges from conservative, such as cognitive behavioral therapy (CBT) and antidepressants, to minimally invasive management. Minimally invasive management involving ranscutaneous electrical acupoint stimulation of target points has demonstrated significant improvement in fatigue and associated symptoms in a 2017 randomized controlled study. The understanding of CFS is evolving before us as we continue to learn more about it. As further reliable studies are conducted, providing a better grasp of what the syndrome encompasses, we will be able to improve our diagnosis and management of it.

A Pilot Study of Online Yoga to Improve Fatigue and Quality of Life in Myeloproliferative Neoplasm Patients

Introduction: Polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF) are myeloproliferative neoplasms (MPNs) with impact on patients that include cytopenias, vascular risk, and disease specific symptom burden. Fatigue is the most commonly reported symptom among MPN patients, contributing to a reduced overall quality of life (QoL). Fatigue and reduced QoL are often left unresolved with current pharmacologic therapy. Our prior work has demonstrated the feasibility of online-streamed yoga and its preliminary effects for improving total symptom burden (including fatigue) in MPN patients. The purpose of this study was to further examine the effects of a 12-wk online yoga intervention for fatigue and QoL in MPN patients as compared to a wait-list control group as well as the feasibility of collecting remote blood samples, for remote assessment of corresponding biomarkers, in a national sample of MPN patients.Methods: MPN patients were recruited nationally using social media and MPN patient group partners. Participants were randomized to either an intervention (i.e., yoga) group or a wait-list control group. The intervention group was asked to complete 60 min/wk of online yoga (via Udaya.com, an online yoga streaming platform) for 12 wks as well as a blood draw (complete blood cell count (CBC), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-a)) at both wk 0 and post-intervention wk 12. Those in the control group were asked to maintain their normal level of activity for 16 wks. All study participants were asked to complete online self-report surveys administered via Qualtrics. Survey measures included demographics, MPN Symptom Assessment Form (MPN SAF) as well as National Institutes of Health Patient Reported Outcomes Measurement Information System (NIH PROMIS). Surveys were administered at baseline (wk 0), mid-point (wk 7), and post-intervention (wk 12). Weekly yoga minutes were collected with online self-report and objectively with an online web analytics tool (i.e., Clicky). The feasibility of the remote blood draw was defined as a ≥70% completion rate at both wk 0 and wk 12. Questionnaire outcomes were compared between groups at 12 wks using analysis of covariance adjusting for baseline and changes in blood draw variables were analyzed using dependent t-tests.Results:Patients: Two hundred and sixty MPN patients completed the eligibility survey, of which 96 were eligible, 62 completed the informed consent, and 48 MPN patients completed the 12-wk intervention. There were no significant differences in demographic variables or outcome variables (i.e., fatigue and QoL) between the intervention group (n=27) and the control group (n=21) at baseline. Table 1 describes study participant demographics.Yoga Participation: Over the course of the 12-wk intervention, objective yoga participation averaged 40.8 min/wk whereas self-report yoga participation averaged 56.1 min/wk. Figure 1 depicts the trends in objective and self-report yoga participation throughout the 12-wk intervention.Impact of Yoga Intervention: There were no significant differences at wk 12 in MPN SAF fatigue (ES=0.18; p=0.72) or MPN SAF QoL (ES=-0.53; p=0.19), however, NIH PROMIS QoL was significantly better in the yoga group at wk 12 (ES=0.7; p=0.03) when compared to the control group. Table 2 describes the changes in fatigue and QoL throughout the 12-wk intervention.Blood Draw Feasibility: At baseline, 92.6% (n=25/27) of yoga group participants completed the blood draw and 70.4% (n=19/27) completed the blood draw at post-intervention. There was a significant decrease in TNF-a from wk 0 to wk 12 (-1.3±1.5; p=0.005) but no significant differences in CBC or IL-6 from wk 0 to wk 12.Conclusions: This study builds upon our prior work demonstrating the feasibility of online yoga as well as its preliminary effects for improving symptom burden in MPN patients. In light of the improvements in QoL compared to the control group and significant decreases in TNF-a as well as the feasibility of remote blood draws in the present study, a future randomized controlled trial is warranted. It is possible that we did not see significant improvements in fatigue due to small sample sizes; therefore, a larger, more representative (i.e., more men) sample size is warranted in order to further investigate the effectiveness of online yoga on MPN patient symptom burden, QoL, and pro-inflammatory biomarkers. [Display omitted] DisclosuresMesa:Ariad: Consultancy; Incyte Corporation: Research Funding; Gilead Sciences, Inc.: Research Funding; CTI BioPharma Corp.: Research Funding; Celgene Corporation: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; Galena Biopharma, Inc.: Consultancy; Promedico: Research Funding.

A short-term exercise program in patients with multiple sclerosis: is body mass index important?

Obesity is a health problem that can exacerbate the symptoms of multiple sclerosis (MS). In the current study, we aimed to investigate the effectiveness of a short-term exercise program on fatigue, depression, anxiety, and walking performance in normal-weight and overweight patients with MS (PwMS). Sixty-two PwMS were divided into groups according to their BMI (BMI normal/BMI high). Also, they were all included in the exercise program. The participants took a moderate-intensity walking program 5 days a week for 4 weeks, including 30 min between 5 min of warm-up and 5 min of cooling periods. Also, patients underwent breathing, posture, flexibility, and stretching exercises for 4 weeks. Fatigue, depression, anxiety, 6-minute walking test (6MWT), and BMI were measured before and after the 4 weeks. After the exercise program, there were statistically significant improvements in fatigue, depression, anxiety, and the 6MWT. However, no relation could be detected between the examined variables and BMI. All patients participated effectively in the exercise program, regardless of BMI. The results obtained from this study support that a short-term exercise program is an effective therapeutic intervention, unrelated to BMI, in improving fatigue, depression, anxiety, and walking performance in PwMS.

Development and validation of a hepatitis B-specific health-related quality-of-life instrument: CLDQ-HBV.

Hepatitis B virus (HBV) carries a large global burden. Efforts abound to decrease the burden, which necessitates reporting of patient-reported outcomes (PROs). We aimed to develop and validate an HBV-specific PRO instrument using the Chronic Liver Disease Questionnaire (CLDQ). Data were obtained from patients enrolled in our HBV registries who completed the CLDQ, Short Form-36 (SF-36) and FACIT-F. The sample was split randomly 1:1 into training and testing groups. A standard PRO instrument validation pipeline was used to develop and validate the new CLDQ-HBV instrument. HBV patients (n=1,339) were 48±13years old, 60% male, 8% cirrhosis, with 53% receiving oral antivirals (OAV). After reduction of 10 redundant items, exploratory factor analysis for the remaining 19 items found 95% of variance was explained by five factors-emotional function, fatigue, systemic symptoms, worry and sleep. Good-to-excellent internal consistency was found: Cronbach's alphas 0.70-0.90 and item-to-own-domain correlations >0.50 for 18/19 items. Known-group validity tests discriminated between HBV patients with and without cirrhosis, with FIB-4≥3.25 vs <3.25, with and without history of depression or clinically overt fatigue (all p<0.0001), and treatment (all p<0.05, all but one <0.0001). After 48-week follow-up, HBV patients receiving OAV (N=144) with ≥2.7 log 10/mL decline in HBV viral load experienced significant improvements in fatigue, worry and total CLDQ-HBV scores (p<0.05). The newly developed CLDQ-HBV is a short, disease-specific PRO instrument for HBV patients which was developed and validated using large data set and an established methodology showing excellent psychometric characteristics.

Effects of Yoga in Daily Life program in rheumatoid arthritis: A randomized controlled trial

ObjectivesTo explore the feasibility and effectiveness of a yoga program in improving health-related quality of life (HQOL), physical and psychological functioning in rheumatoid arthritis (RA) patients. DesignSingle-centre parallel-arms randomized controlled trial comparing yoga (n = 30) and education control group (n = 27). SettingTertiary care University hospital. InterventionA 12-week yoga program, based on the Yoga in Daily Life system, included 2x weekly/90-minute sessions. The control group had 1xweekly/60-minute educational lectures on arthritis-related topics. Main outcome measuresAssessments were performed at baseline, 12 (post-intervention) and 24 weeks (follow-up). The primary outcome was change in The Short Form-36 (SF-36) HQOL at 12 weeks. Linear regression analysis was adjusted for baseline scores. ResultsNo significant between-group differences were found for SF-36 (all p > 0.05). At 12 weeks the adjusted mean difference between groups favoured yoga for Functional Assessment of Chronic Illness Therapy-fatigue (5.08 CI 1.29 to 8.86; p = 0.009) and Hospital Anxiety and Depression Scale (HADS)-depression (−1.37 CI −2.38 to −0.36); p = 0.008) and at 24 weeks for HADS-anxiety (−1.79 CI −3.34 to − 0.23; p = 0.025), while the impact on fatigue was sustained (5.43 CI 1.33 to 9.54, p = 0.01). The program had no impact on RA disease activity. Feasibility outcomes included recruitment rate 16 %, retention 80.7 %, and adherence to yoga 87.5 vs 82.7 % for control. No serious adverse events were recorded. ConclusionsYoga in Daily Life program was not associated with change in health-related quality of life of RA patients. Significant improvements in fatigue and mood were observed at postintervention and follow-up. This yoga program was found feasible and safe for patients and may complement standard RA treat-to-target strategy.

Treatment of Immune Thrombocytopenia (ITP) with Eltrombopag - Results of the 3rd Interim Analysis of the German Non-Interventional Trial RISA

Background:Immune thrombocytopenia (ITP) is an acquired autoimmune disorder, characterized by increased platelet destruction and impaired platelet production. Therefore, affected patients present with bleeding complications of various severity. However, another frequent complication of ITP is fatigue, which is often underestimated. In Europe the oral thrombopoietin receptor agonist Eltrombopag (EPAG) is licensed for the treatment of patients with persistent and chronic ITP who are refractory to previous treatments. EPAG has previously been shown to elevate platelet count and reduce bleeding complications in ITP patients, but the therapeutic effect on fatigue is unclear. Here we present data from the scheduled 3rd interim analysis of the RISA study. Methods:RISA is an ongoing, single-cohort, non-interventional, multicenter observational study. The individual follow-up period is approximately 24 months. Dosage of EPAG and treatment of patients follows the Summary of Product Characteristic (SmPC) or the routine of treating physicians. Fatigue is assessed at baseline and during the study using the FACIT-Fatigue Scale (Version 4). Annual interim analyses are performed to assess treatment effectiveness and safety. For this interim analysis, an evaluation of patients with prior application of Rituximab is planned. Results:210 patients received at least one dose of EPAG and completed one post baseline assessment. Mean±SD age was 63.1±17.4 years, median (range) duration of ITP was 5.6 (0.0- 44.9) years, 10% were splenectomized, 52.4% were female, median platelet count (range) at baseline was 33.5x109/L (0.0-270.0), 37.6% reported bleeding complications (any grade) within 12 months prior baseline (WHO °I 30% , °II 4.8% , °III 1.9% , °IV 0% , 1% grade missing), 85.2% received prior ITP therapy, and 81.4% had at least one concomitant disease. At least one pre-treatment was given to 179 patients. More than half received prednisolone (46.2%) or prednisone (9%) and 24.3% dexamethasone or immuno globulins (20%). Rituximab as pre-treatment was given to 2.9% of the patients but further analysis is not possible due to the small number. Mean±SD daily dose of EPAG was 45.1±14.4 mg. Treatment with EPAG increased median (range) platelet count to 90x109/L (2.0-617.0) within one month. After two years of treatment median (range) platelet count was 122 (9.0-335.0) (Fig. 1). After one month, 75% of the patients showed treatment response, after 24 months 89 % of the patients exhibited platelet counts above 50x109/L. At baseline mean±SD FACIT-Fatigue Score was 36.3±11.1 and remained unchanged during the two-year observation period (38.0±13.3) (Fig. 1). In a first subgroup analysis, 55 (31%) of 175 patients with an evaluable questionnaire at baseline suffered from severe fatigue (score &amp;lt;=30) with a mean±SD FACIT-Fatigue Score of 22.4±5.7. Due to the small number of evaluable questionnaires, especially at 12 and 24 months (n=11 and n=4), no reliable results could be provided at this time. A total of 166 patients (79%) reported any adverse events (AEs) (n=656), 57 patients (27.1%) experienced 126 serious AEs (SAEs) incl. 9 patients (4.3%) with 12 drug related SAEs. A total of 15 patients (7.1%) were reported to have experienced 27 events with fatal outcome. None of the fatal events was assessed causally related to EPAG. Within the first month of treatment 11 of 202 patients (5.4%) reported bleeding complications (any grade) and after two years 2 of 51 (3.9%). Eleven severe thromboembolic events were observed and 2 mild ones (4 severe and one mild related to EPAG). Discussion:In this 3rd interim analysis it was shown that therapy with EPAG increased the platelet count and reduced bleeding events. No new safety risks were reported despite many concomitant diseases and therapies in these patients. The analysis of the fatigue questionnaire revealed that ITP patients suffer from fatigue, similar to cancer patients and 31% of the patients suffered already from a severe fatigue at baseline. To date, the RISA study could not demonstrate that therapy with EPAG leads to a clinically significant improvement in fatigue. In Germany, ITP patients rarely receive Rituximab prior to EPAG despite their older age and comorbidities. This restrained use of Rituximab is in accordance with the current clinical guidance in Germany. The results in this non-interventional trial are in alignment with the outcomes of other clinical trials with EPAG. Figure Disclosures Meyer: Amgen GmbH:Honoraria;Novartis Pharma GmbH:Honoraria;Grifols Germany:Consultancy, Honoraria.Reiser:Celgene:Consultancy, Honoraria;Roche:Consultancy, Honoraria;BMS:Honoraria;CSL Behring:Honoraria.Plath:Novartis Pharma GmbH:Honoraria.Ballerstädt:Novartis Pharma GmbH:Current Employment.Stark-Lorenzen:Novartis Pharma GmbH:Current Employment.Matzdorff:Novartis Oncology:Consultancy, Other: Honoraria paid to institution;Amgen GmbH:Consultancy, Other: Honoraria paid to institution;Grifols Deutschland GmbH:Consultancy, Other: Honoraria paid to institution;Swedish Orphan Biovitrium GmbH:Consultancy, Other: Honoraria paid to institution;UCB Biopharma SRL:Consultancy, Other: Honoraria paid to institution;Roche Pharma AG:Other: Family stockownership. OffLabel Disclosure: Rituximab has not been licensed for the treatment of ITP and rituximab is not being, and is not intended to be, used to treat patients in this trial. However, some patients have been pretreated with rituximab outside this trial.

Physical health-related quality of life at higher achieved hemoglobin levels among chronic kidney disease patients: a systematic review and meta-analysis

BackgroundThe impact of anemia treatment with erythropoietin stimulating agents (ESA) on health-related quality of life (HRQOL) in chronic kidney disease (CKD) patients is controversial, particularly regarding optimal hemoglobin (Hb) target ranges.MethodsWe conducted a systematic review and meta-analysis of observational studies and randomized controlled trials (RCT) with ESA to estimate the effect of different achieved Hb values on physical HRQOL and functionality. We searched PubMed, EMBASE, CENTRAL, PEDro, PsycINFO and Web of Science databases, until May 2020. Two authors independently extracted data from studies. We included observational and RCTs that enrolled CKD patients undergoing anemia treatment with ESA with different achieved Hb levels among groups. We excluded studies with achieved Hb < 9 g/dL. For the meta-analysis, we included RCTs with control groups achieving Hb 10–11.5 g/dL and active groups with Hb > 11.5 g/dL. We analyzed the standardized mean difference (SMD) between groups for physical HRQOL.ResultsAmong 8496 studies, fifteen RCTs and five observational studies were included for the systematic review. We performed the meta-analysis in a subset of eleven eligible RCTs. For physical role and physical function, SMDs were 0.0875 [95% CI: − 0.0025 – 0.178] and 0.08 [95% CI: − 0.03 – 0.19], respectively. For fatigue, SMD was 0.16 [95% CI: 0.09–0.24]. Subgroup analysis showed that trials with greater achieved Hb had greater pooled effects sizes — 0.21 [95% CI: 0.07–0.36] for Hb > 13 g/dL vs. 0.09 [95% CI: 0.02–0.16] for Hb 11.5–13 g/dL. Proportion of older and long-term diabetic patients across studies were associated with lower effect sizes.ConclusionAchieved hemoglobin higher than currently recommended targets may be associated with small but potentially clinically significant improvement in fatigue, but not in physical role or physical function. Younger and non-diabetic patients may experience more pronounced benefits of higher Hb levels after treatment with ESAs.

Evaluation Of An Exercise Referral Programme For Young Adult Cancer Survivors In The United Kingdom

PURPOSE: Exercise referral programmes delivered by charity organizations have the potential to facilitate cancer survivors to be active. The purpose of this work was evaluate the uptake and effect of RENEW, a twelve-week exercise referral programme for young adult cancer survivors aged 18 to 39 delivered by Trekstock, a cancer charity based in the UK. METHODS: The RENEW programme provides one-to-one individually tailored support from a Level 4 Cancer Rehabilitation qualified gym instructor, free gym membership and access to information resources online. Objective and self-report data on cardiorespiratory function, flexibility, fat mass, muscle mass, fatigue, sleep quality and general health-related quality of life (HRQoL) was collected from participants before the programme (week 0), immediately after (week 12) and one month later (week 16). RESULTS: Ninety-eight RENEW referrals were made between August 2018 and May 2019, 76 young adults with cancer initiated the programme with 48 young adults (83% female; mean age 29 yrs; 73% off active treatment) consenting to participate within the evaluation. The predominant cause of programme drop-out was illness or treatment complications. Physical activity (PA) levels significantly increased following the programme and remained raised at follow-up. Improvements in physical function were significant: peak expiratory flow (mean change: 30.96, p=0.003), sit-and-reach test (mean change: 6.55±4.54, p<0.0001), and six-minute-walk-test (mean change 0.12±0.04, p<0.0001). Significant improvements in fatigue, sleep and HRQoL were observed across the programme and at follow-up (mean change W0-W16; 8.04±1.49; 1.05±0.49; and -0.9±0.46 respectively, p<0.05). Changes in self-efficacy to exercise and motivations to exercise were not observed at 12 weeks or at follow-up. CONCLUSIONS: Results suggest that the RENEW exercise referral programme has a positive effect upon young adult cancer survivors’ physical function, PA levels, HRQoL and well-being. Health professionals and charitable bodies specialising in the care of young adults with cancer should look to address factors (including gender and treatment status) which prevent engagement and uptake of ‘real-world’ PA interventions such as the RENEW programme.

Effects of web-based education and counselling for patients with systemic lupus erythematosus: self-efficacy, fatigue and assessment of care

The aim of this study was to determine the effect of web-based education and counselling for patients with systemic lupus erythematosus on self-efficacy, fatigue and assessment of care. The study was conducted as a randomized controlled trial. The study sample consisted of 80 patients divided into two groups: the experimental group (n = 40) and a control group (n = 40). Randomization was performed by simple random sampling. At the beginning of the study (month 0), data-collection forms were administered to both groups. Web-based education was carried out for the first three months, and counselling and information updates were given for the next three months for the experimental group. In the intervention process, the control group just received standard care. After six months, data-collection forms were administered to both groups again. The mean age of the participants in the experimental and control groups was 35.58 ± 8.40 years and 39.00 ± 12.71 years, respectively. In both groups, 95% of patients were women. Wilcoxon's test was used for within-group comparisons before and after the study. The Mann-Whitney U-test was used to evaluate the difference between the two groups before the intervention and between the two groups after the intervention. We found that there was a significant improvement in fatigue, self-efficacy and assessment of chronic illness care in the experimental group at the end of the study (p < 0.05). The intervention had a positive effect on self-efficacy, fatigue and satisfaction with chronic illness. In accordance with the results, similar studies should be conducted for different patient groups in order to strengthen the results.

Nutrition counseling combined with head and neck rehabilitation exercises can enhance outcomes among nasopharyngeal carcinoma patients in southern China: a prospective study in an epidemic area.

More than two thirds of new of nasopharyngeal carcinoma (NPC) cases occurring in the east and southeast parts of Asia. As a consequence, the development of intervention programs that can educate and assist patients of NPC in adopting and maintaining long-term behavioral changes to prevent further progression of the disease and improve quality of life represents a continuing need. Patients diagnosed with NPC (n=141) completed chronic disease self-management questionnaires (CDSMP) before, immediately after, and 3, 6, and 12 months after receiving primary cancer treatment. An independent-samples T test was used to compare mean changes in chronic disease self-management (CDSM) items between the intervention group and control group. There was no difference between the two groups at baseline. Patients who received an intervention demonstrated a significant improvement in fatigue and shortness of breath after treatment. They also demonstrated significant improvements in weekly minutes of aerobic exercise and stretching/strengthening exercise. These advantages lessened slightly with elapsed time. For NPC patients, nutrition counseling combined with head and neck rehabilitation exercises can greatly reduce fatigue and shortness of breath and greatly increase the use of stretching/strengthening and aerobic exercise 3 months after intensity-modulated radiotherapy (IMRT).

Quantifying and predicting the effect of anti-TNF therapy on axSpA-related fatigue: results from the BSRBR-AS registry and meta-analysis.

ObjectivesEffective management of axial spondyloarthritis (axSpA)-related fatigue is a major unmet clinical need. Anti-TNF therapy may reduce fatigue levels, although any effect has yet to be definitively quantified and predictors of any such improvements are unknown.MethodsThe British Society of Rheumatology Register in Axial Spondyloarthritis (BSRBR-AS) prospectively recruited axSpA patients across the UK. Changes in fatigue levels (measured using the Chalder Fatigue Scale) >1 year were compared between those starting anti-TNF therapy at the time of recruitment and those not. Differences between treatment groups were adjusted using propensity score matching. Results were meta-analysed with the extant literature to calculate pooled estimates. Then, among those BSRBR-AS anti-TNF commencers with clinically relevant fatigue, baseline predictors of response were investigated.ResultsOf the 998 BSRBR-AS recruits with complete fatigue data, 310 were anti-TNF commencers. At 1-year follow-up, the former group reported a mean fatigue change of −2.6 (95% CI −4.1, −1.9) points while the latter reported a mean worsening of fatigue by 0.2 points. Following propensity score adjustment, those commencing anti-TNF therapy reduced fatigue by 3.0 points compared with those not. Of those with significant fatigue and commencing anti-TNF, poor sleep quality at baseline predicted fatigue improvement. In the meta-analysis, including 1109 subjects, treatment with anti-TNF therapy resulted in a significant improvement in fatigue [Standardized mean difference (SMD) = 0.36, 95% CI 0.15, 1.56].ConclusionAnti-TNF therapy results in a significant but modest reduction in fatigue amongst axSpA patients, with those reporting poor sleep quality most likely to report improvement. Effective management will likely require additional approaches.

Impact of a Strategic Napping Program During Call in an OBGYN Residency Program [16G

INTRODUCTION: Call shifts correlate with resident fatigue, impaired performance, and adverse events; furthermore, residency programs are required to practice fatigue mitigation. Our objectives were to implement and assess use of and perceptions about a napping program. METHODS: We implemented a protected 30 minute minimum Nighttime Alone Period (NAP) during 24-hour call shifts for residents. The NAP could be used for any activity other than work (e.g. sleeping, studying, exercise). With IRB approval and informed consent obtained, we distributed anonymous Pre- and Post- program surveys to assess perceptions of the NAP program, twelve weeks apart. Residents answered weekly surveys to assess NAP activity and barriers. We used the Stanford Sleepiness Scale to assess fatigue. RESULTS: 36 NAPs were taken out of a total of 51 possible opportunities (71%) over 12 weeks. Mean time of NAP was 119 minutes (SD 102). 4th-year residents took longer NAPs than 1st-years (175 minutes [SD 140] versus 73 minutes [SD 76]) (P=.04). Residents reported a significant improvement in fatigue following each rest period (P=.001). Barriers to NAP included pages, phone calls or texts, and in-person interruption. In the post-survey, 85% of residents and 43% of attendings supported resident participation in a NAP program. 42% of residents felt there was an associated stigma. CONCLUSION: We successfully implemented a NAP program and extended rest periods during call shifts improved perceived sleepiness, but there was perception of associated stigma. Efforts to decrease the stigma will enhance personal wellness and patient safety.

P260 The efficacy of biologic treatment in improving fatigue in ankylosing spondylitis: a literature review and implications for clinical practice

Abstract Background Ankylosing spondylitis (AS) is a chronic, inflammatory condition that predominantly manifests as arthritis in the axial skeleton. AS related fatigue remains under-researched despite evidence that it is an important contributor to the quality of life in these patients. The impact of biologic therapy on fatigue in patients with AS is not fully understood. Furthermore, it is not clear whether any of the licensed biologic drugs are more effective in treating fatigue in AS than others. The aim of this review is to critically appraise the evidence regarding the effectiveness of biologic agents in treating AS associated fatigue to help guide clinical practice. Methods Pre-defined search terms were entered into PubMed and Embase to identify papers studying the effectiveness of etanercept, adalimumab, infliximab, golimumab, certolizumab pegol and secukinumab in AS associated fatigue. Results were restricted to those published in English from 1990 onwards. 64 papers were initially identified and screened using predefined exclusion criteria; of these, 13 were selected for final inclusion. Results No head-to-head studies analysing fatigue were identified and all studies included analysed fatigue as a secondary outcome measure. Most studies utilised a single question fatigue measurement such as the BASDAI fatigue score. Variation in methodology precluded a meta-analysis. There is evidence that all six biologics improve fatigue in AS to varying degrees. For etanercept, three out of four studies found significant improvement compared to placebo at week 12 and week 54. However, one study that utilised a more robust form of fatigue assessment found no significant differences between etanercept and placebo at week 12. For Adalimumab, two studies were identified, both of which were robust and suggested strong efficacy in treating AS associated fatigue at week 12. For infliximab, two out of three studies were open label trials which showed significant improvement in fatigue at week 6. The third study was a post-hoc analysis of a randomised placebo-controlled trial and showed improvement in fatigue scores at week 24. Two studies were identified for Golimumab, both of which showed significant improvement in fatigue scores at week 24 and week 104 respectively. One placebo-controlled trial of certolizumab pegol showed significant improvement in fatigue at week 24. For secukinumab, one study was identified: a post-hoc analysis of a randomised, placebo-controlled trial. This showed a significant improvement in fatigue at week 16; however, this improvement was not sustained at week 104. Conclusion Although none of the studies analysed fatigue as a primary outcome measure, it appears that biologic treatment overall is successful to varying degrees in the treatment of AS associated fatigue. Future studies would benefit from utilising robust fatigue assessments, comparing biologics, and evaluating long-term effectiveness. In addition, vigilance in recognising fatigue and subsequent considered holistic management is paramount. Disclosures R. Amarnani None. A. Soni Grants/research support; Oxford-UCB Prize Fellowship.

O25 Quantifying and predicting the effect of anti-TNF therapy on axSpA-related fatigue: results from the BSRBR-AS registry and meta-analysis

Abstract Background Fatigue represents a critical priority among patients with axial spondyloarthritis (axSpA). Its effective management is a major unmet clinical need. Existing studies indicate that anti-TNF therapy may reduce fatigue levels, although any effect has yet to be definitively quantified. Moreover, predictors of any such improvements have not been studied. Methods The British Society for Rheumatology Register in Axial Spondyloarthritis (BSRBR-AS) prospectively recruited axSpA patients across 83 centres in the UK. Changes in fatigue levels (measured using the Chalder Fatigue Scale (0-33)) over 1 year were compared between those starting anti-TNF therapy at the time of recruitment and those not. Differences between treatment groups were adjusted using propensity score matching. Results were combined with other studies in a meta-analysis to calculate pooled estimates. Then, among those BSRBR-AS anti-TNF commencers with clinically relevant fatigue, baseline predictors of response were investigated. Results Of the 998 BSRBR-AS recruits with complete fatigue outcome data, 310 were anti-TNF commencers and 688 were not. At 1 year follow-up, the former group reported a mean change in fatigue of -2.6 (95% CI -4.1, -1.9) points while the latter reported a mean worsening of fatigue by 0.2 points. Following propensity score adjustment, those commencing anti-TNF therapy reduced fatigue by 3.0 points compared to those not 95% CI (-4.1-1.9). In the meta-analysis, including 1109 subjects across 5 observational studies and trials, treatment with anti-TNF therapy resulted in a significant improvement in fatigue (SMD 0.36, 95% CI 0.15-1.56). Of those BSRBR-AS recruits commencing anti-TNF, n = 205 (66%) reported clinically significant fatigue at baseline of whom n = 139 (68%) experienced a clinically relevant improvement in their fatigue at 1 year. Poor sleep quality at baseline was predictive of fatigue improvement. Conclusion Anti TNF therapy results in a significant but modest reduction in fatigue amongst axSpA patients, with those reporting poor sleep quality most likely to report improvement. Effective management will likely require additional, possibly non-pharmacological, approaches. Disclosures J. Shim None. L. Dean None. M. Karabayas None. G. Jones None. G. Macfarlane None. N. Basu None.