Quality of life, fatigue, sleep quality, and mental health in systemic lupus erythematosus patients with a high cardiovascular risk profile.

Systemic lupus erythematosus (SLE) patients report worse health-related quality of life (HRQL), fatigue, anxiety, depression, and sleep quality, when compared to the general population and other chronic diseases. Furthermore, cardiometabolic diseases are highly prevalent in SLE and are also associated with these parameters. Thus, it is plausible to suggest that SLE patients with a high cardiovascular risk may report worse results for these parameters. The aim of the study is to describe HRQL, fatigue, anxiety and depression symptoms, and sleep quality in a sample of SLE patients with a high cardiovascular risk profile (i.e., BMI between 25 and 40 kg/m2 and/or dyslipidemia, hypertension, or diabetes). This was a cross-sectional study where patients were assessed for (i) demographic, anthropometric, and disease-related parameters, (ii) HRQL, (iii) fatigue, (iv) anxiety and depression symptoms, and (v) sleep quality. One-hundred patients completed the study; however, only 87 patients were assessed for sleep quality data. Patients averaged 41.7 ± 9 years, and most patients were classified as overweight/obese (87%). SF-36 scores for physical and mental components summary were 51.3 ± 9.6 and 54.2 ± 15.6, respectively, with "bodily pain" and "role emotional" presenting the lower scores. The total SLEQOL score was 105.1 ± 42.0, with lower scores reported for "self-image" and "mood." Fatigue score was 30.8 ± 8.9, and 78% and 93% reported severe symptoms of anxiety and depression, respectively. The average sleep effectiveness was 82.9 ± 6.6%. Sleep latency, total time in bed (TTiB), and total sleep time (TST) were 8.4 ± 8.9, 495.8 ± 79.7, and 409.7 ± 69.9 min, respectively. Patients reported an average of 17.8 ± 6.2 WE, with 4.5 ± 1.5 min duration and a WASO of 77.7 ± 36.6 min. Despite similar HRQL, fatigue, and sleep quality parameters to those reported by other SLE populations, SLE patients with a high cardiovascular risk had a higher prevalence of depression and anxiety. Understanding SLE patients' quality of life and psychological symptoms is of utmost importance to improve disease management. The findings of this study highlight the need for more intensive and global care regarding mental health when considering a high cardiovascular risk in SLE.

A randomized controlled trial of an intervention promoting physical activity and healthy eating recommendations in systemic lupus erythematosus: the protocol study "Living Well with Lupus".

There is a paucity of studies assessing multidisciplinary interventions focused on tackling physical inactivity/sedentary behavior and poor dietary habits in SLE. The Living well with Lupus (LWWL) is a randomized controlled trial to investigate whether a six-month lifestyle change intervention will improve cardiometabolic risk factors (primary outcome) among systemic lupus erythematosus (SLE) patients with low disease activity (SLEDAI score ≤ 4) and with high cardiovascular risk. As secondary goals, we will evaluate: (1) the intervention's safety, efficacy, and feasibility in promoting lifestyle changes, and (2) the effects of the intervention on secondary outcomes (i.e., clinical parameters, functional capacity, fatigue, psychological aspects, sleep quality and health-related quality of life). Patients will be randomly allocated to either a control (i.e., standard care) or a lifestyle intervention group using a simple randomization (1:1 ratio, blocks of 20). Mixed Model analyses will be conducted for comparing groups following an intention-to-treat approach. A per protocol analysis will also be conducted. This study has the potential to generate new, clinically relevant data able to refine the multidisciplinary management of SLE patients. Protocol version number: NCT04431167 (first version).

Association between physical activity and immunogenicity of an inactivated virus vaccine against SARS-CoV-2 in patients with autoimmune rheumatic diseases.

OBJECTIVES: To investigate whether physical activity is associated with enhanced immunogenicity of a SARS-CoV-2 inactivated vaccine (Coronavac) in patients with autoimmune rheumatic diseases (ARD) (n = 898) and in non-ARD (n = 197) individuals without pre-existing immunogenicity to SARS-CoV-2. METHODS: This was a prospective cohort study within an open-label, single-arm, phase 4 vaccination trial. Immunogenicity was assessed after vaccination by measuring seroconversion rates of total anti-SARS-CoV-2 S1/S2 IgG (SC), geometric mean titers of anti-S1/S2 IgG (GMT), factor-increase in GMT (FI-GMT), frequency of neutralizing antibody (NAb), and median neutralizing activity. Physical activity (active being defined as ≥ 150 min/week) and sedentary behavior (>8h/day) were assessed by questionnaire. RESULTS: Physically active ARD patients (n = 494) were younger and less frequently used prednisone/biologics than inactive patients (n = 404). After controlling for covariates, active patients exhibited greater SC (OR: 1.4 [95%CI: 1.1-2.0]), GMT (32% [95%CI: 8.8-60) and FI-GMT (33% [95%CI: 9.6-63%]) vs. inactive. Cluster analysis (physical activity/sedentary status) revealed greater GMT (43.0% [95% CI: 11.0-84.0%) and FI-GMT (48.0% [95%CI: 14.0-92.0%]) in active/non-sedentary vs. inactive/sedentary ARD patients. A dose-response was observed, with greater benefits for the group of patients performing ≥ 350 min/week of physical activity (OR: 1.6 [95%CI: 1.1-2.4]; 41% [95%CI: 10-80%]; 35% [95%CI: 4.3-74], for SC, GMT, and FI-GMT, respectively) vs. the least active group (≤30 min/week). Greater SC (OR: 9.9 [95%CI: 1.1-89.0]) and GMT (26% [95%CI: 2.2-56.0%]) were observed in active vs. inactive non-ARD. CONCLUSIONS: A physically active lifestyle may enhance SARS-CoV-2 vaccine immunogenicity, a finding of particular clinical relevance for immunocompromised patients. TRIAL REGISTRATION: Clinicaltrials.gov #NCT04754698.

A home-based exercise program during COVID-19 pandemic: Perceptions and acceptability of juvenile systemic lupus erythematosus and juvenile idiopathic arthritis adolescents.

OBJECTIVES: To investigate the perceptions and acceptability of a home-based exercise intervention in systemic lupus erythematosus (JSLE) and juvenile idiopathic arthritis (JIA) adolescent patients during the COVID-19 pandemic, and to explore the effects of the intervention on health-related quality of life (HRQoL), sleep quality, and mental health conditions parameters. METHODS: This was a randomized controlled trial of a 12-week, home-based exercise training program conducted between October and December 2020. During this period, social distancing measures were in place in Brazil to contain the spread of COVID-19. Adolescent patients diagnosed with JSLE and JIA participated in the study. Health-related qualitative and quantitative data were collected before and after the follow-up. RESULTS: 21 JSLE patients and 30 JIA patients were analyzed. Six themes emerged from patients' feedback: 1) Suitability of the home-based format; 2) Appropriate trainer supervision, 3) Motivators and facilitators for the program; 4) Barriers to the program; 5) Health benefits; 6) Patients' suggestions to improve the program. Overall, data indicated that the intervention showed good acceptability and elicited improvements in the perceived HRQoL and fatigue in JIA and JSLE patients during the pandemic. However, further quantitative analyses with validated HRQoL, sleep quality, and mental health conditions instruments did not capture these benefits (p>0.05). CONCLUSION: Our main findings based on in-depth qualitative assessments suggest that a home-based exercise training program was suitable and well-accepted by adolescents with JSLE and JIA during the COVID-19 pandemic. Nonetheless, adherence was not high, particularly among JIA patients, suggesting that facilitators and barriers identified in the current study should be explored to improve the quality of new home-based exercise programs implementation, particularly in a future emerging crisis.

Physical activity and antibody persistence 6 months after the second dose of CoronaVac in immunocompromised patients.

This prospective cohort study within an open-label, single-arm, phase 4 vaccination trial (clinicaltrials.gov #NCT04754698) aimed to investigate the association between physical activity and persistent anti-SARS-CoV-2 antibodies 6 months after two-dose schedule of CoronaVac in autoimmune rheumatic diseases (ARD) patients (n = 748). Persistent immunogenicity 6 months after the full-course vaccination was assessed using seroconversion rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), and frequency of positive neutralizing antibodies (NAb). Physical activity was assessed trough questionnaire. Adjusted point estimates from logistic regression models indicated that physically active patients had greater odds of seroconversion rates (OR: 1.5 [95%CI: 1.1 to 2.1]) and NAb positivity (OR: 1.5 [95%CI: 1.0 to 2.1]), and approximately 43% greater GMT (42.8% [95%CI: 11.9 to 82.2]) than inactive ones. In conclusion, among immunocompromised patients, being physically active was associated with an increment in antibody persistence through 6 months after a full-course of an inactivated SARS-CoV-2 vaccine.

Effects of physical activity on vascular function in autoimmune rheumatic diseases: a systematic review and meta-analysis.

OBJECTIVES: To summarize existing evidence and quantify the effects of physical activity on vascular function and structure in autoimmune rheumatic diseases (ARDs). METHODS: Databases were searched (through March 2020) for clinical trials evaluating the effects of physical activity interventions on markers of micro- and macrovascular function and macrovascular structure in ARDs. Studies were combined using random effects meta-analysis, which was conducted using Hedges' g. Meta-analyses were performed on each of the following outcomes: microvascular function [i.e. skin blood flow or vascular conductance responses to acetylcholine (ACh) or sodium nitropusside (SNP) administration]; macrovascular function [i.e. brachial flow-mediated dilation (FMD%) or brachial responses to glyceryl trinitrate (GTN%); and macrovascular structure [i.e. aortic pulse wave velocity (PWV)]. RESULTS: Ten studies (11 trials) with a total of 355 participants were included in this review. Physical activity promoted significant improvements in microvascular [skin blood flow responses to ACh, g = 0.92 (95% CI 0.42, 1.42)] and macrovascular function [FMD%, g = 0.94 (95% CI 0.56, 1.02); GTN%, g = 0.53 (95% CI 0.09, 0.98)]. Conversely, there was no evidence for beneficial effects of physical activity on macrovascular structure [PWV, g = -0.41 (95% CI -1.13, 0.32)]. CONCLUSIONS: Overall, the available clinical trials demonstrated a beneficial effect of physical activity on markers of micro- and macrovascular function but not on macrovascular structure in patients with ARDs. The broad beneficial impact of physical activity across the vasculature identified in this review support its role as an effective non-pharmacological management strategy for patients with ARDs.

Effects of a lifestyle intervention on cardiovascular risk factors in systemic lupus erythematosus patients: The study "Living well with lupus".

OBJECTIVE: The aim of the present study was to investigate the effects of a lifestyle intervention on cardiometabolic risk factors in patients with systemic lupus erythematosus with a high cardiovascular risk profile. METHODS: This trial was conducted in Sao Paulo, Brazil between August 2020 and March 2023. The patients were randomly assigned to lifestyle intervention or control. The intervention was a 6-month multifaced program focused on behavioral changes through personalized recommendations for increasing physical activity (structured and non-structured) and improving eating aspects. Cardiometabolic risk score (primary outcome), anthropometry and visceral fat, aerobic capacity, blood pressure, inflammatory and oxidative stress markers, and blood flow and endothelial function were assessed before and after the intervention. RESULTS: A total of 80 patients were randomized. Twelve and 6 patients dropped out due to personal reasons in the intervention and control groups, respectively. Average adherence rate for the intervention was 56.9%. Intention-to-treat analysis showed no significant difference between groups in the cardiometabolic risk score (intervention group - Pre: 1.7 ± 3.6; Post: -1.6 ± 4.0; control group - Pre: -1.9 ± 3.6; Post: -2.0 ± 3.8; estimated mean difference between groups at post: -0.4; 95% confidence intervals: -2.7; 1.9; p = 0.96). This finding was confirmed by exploratory, per-protocol analysis. No significant differences were observed between adherents vs. non-adherent participants. Secondary outcomes did not change between groups. CONCLUSION: This 6-month, individualized, lifestyle intervention did not improve cardiovascular risk factors in SLE patients with a high cardiovascular risk profile. TRIAL REGISTRATION: clinicaltrials.gov (NCT04431167).

Increased Prolonged Sitting in Patients with Rheumatoid Arthritis during the COVID-19 Pandemic: A Within-Subjects, Accelerometer-Based Study.

BACKGROUND: Social distancing measures designed to contain the COVID-19 pandemic can restrict physical activity, a particular concern for high-risk patient groups. We assessed rheumatoid arthritis patients' physical activity and sedentary behavior level, pain, fatigue, and health-related quality of life prior to and during the social distancing measures implemented in Sao Paulo, Brazil. METHODS: Post-menopausal females diagnosed with rheumatoid arthritis were assessed before (from March 2018 to March 2020) and during (from 24 May to 7 July 2020) social distancing measures to contain COVID-19 pandemic, using a within-subjects, repeated-measure design. Physical activity and sedentary behavior were assessed using accelerometry (ActivPAL micro). Pain, fatigue, and health-related quality of life were assessed by questionnaires. RESULTS: Mean age was 60.9 years and BMI was 29.5 Kg/m2. Disease activity ranged from remission to moderate activity. During social distancing, there were reductions in light-intensity activity (13.0% [-0.2 h/day, 95% CI: -0.4 to -0.04; p = 0.016]) and moderate-to-vigorous physical activity (38.8% [-4.5 min/day, 95% CI: -8.1 to -0.9; p = 0.015]), but not in standing time and sedentary time. However, time spent in prolonged bouts of sitting ≥30 min increased by 34% (1.0 h/day, 95% CI: 0.3 to 1.7; p = 0.006) and ≥60 min increased by 85% (1.0 h/day, 95% CI: 0.5 to 1.6). There were no changes in pain, fatigue, and health-related quality of life (all p > 0.050). CONCLUSIONS: Imposed social distancing measures to contain the COVID-19 outbreak were associated with decreased physical activity and increased prolonged sedentary behavior, but did not change clinical symptoms sitting among patients with rheumatoid arthritis.

Impact of Methyl-Donor Micronutrient Supplementation on DNA Methylation Patterns: A Systematic Review and Meta-Analysis of in vitro, Animal, and Human Studies.

BACKGROUND: DNA methylation patterns are directly associated with diverse metabolic disorders. The status of methyl-donor micronutrients has been associated with DNA methylation levels, and altered ingestion of folate, choline, betaine, B vitamins and methionine may impact genes both globally and at the level of promoter regions. Despite this, the role of methyl-donor micronutrient supplementation on DNA methylation profiles is currently unclear. OBJECTIVES: The aims of this systematic review and meta-analysis were to identify and synthesize the evidence about methyl-donor nutrient supplementation on DNA methylation. METHODS: A systematic literature search was performed in Medline, Embase, Scopus, and Web of Science databases with a combination of terms related to DNA methylation assessment, supplementation, and methyl-donor nutrients. Studies (in vitro, animal models, or human clinical trials) were included if DNA methylation levels after any kind of methyl-donor micronutrient supplementation or treatment was investigated. Studies were assessed for bias using Revised Cochrane risk-of-bias tool for randomized trials, risk-of-bias in Non-randomized Studies of Interventions or Systematic Review Centre for Laboratory Animal Experimentation tools. Data were extracted from studies measuring DNA methylation levels in any sample or tissue, following any kind of methyl-donor micronutrient supplementation or treatment. Separate random-effects meta-analyses were performed for animal model studies and human clinical trials that examined the effects of folic acid supplementation on DNA methylation. RESULTS: Fifty-seven studies were included in this systematic review: 18 human clinical trials, 35 in animal model, and 4 in vitro studies. Concerning overall risk of bias, most of the studies were classified as "high risk" or "some concerns." Meta-analysis with meta-regression from studies in animal models showed that folic acid dose significantly affected DNA methylation and that high and very high doses showed increases in DNA methylation when compared to low doses. However, meta-analysis of human clinical trials showed that folic acid supplementation did not promote significant changes in DNA methylation when compared to placebo. CONCLUSION: Folic acid supplementation may change global DNA methylation levels in animals supplemented with high, as compared to low, doses. Heterogeneity in studies and supplementation protocols make it difficult to establish clinical recommendations. However, these effects, even if small, might be of clinical importance in the management of patients with diseases related to DNA hypomethylation.

Impaired cardiorespiratory fitness and endothelial function after SARS-CoV-2 infection in a sample of mainly immunocompromised youth.

This study aimed to compare cardiopulmonary fitness and endothelial function 6 months after hospital diagnosis in a sample mainly comprising immunocompromised patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection versus noninfected controls. Youth (n = 30; age: 14 yr; 60% females) with confirmed SARS-CoV-2 seen in a tertiary hospital of Sao Paulo, Brazil, were matched by propensity score based on BMI, age, sex, and pre-existing diseases with a control group who had not been tested positive for SARS-CoV-2 infection (n = 30; age: 15 yr; 50% females). Cardiopulmonary fitness (by means of a cardiopulmonary exercise test: CPET) and brachial flow-mediated dilation (%b-FMD) were assessed 3-6 mo after diagnosis. Patients were matched by propensity score based on BMI, age, sex and pre-existing diseases, if any, with a control group who had not been tested positive for SARS-CoV-2. Compared with controls, patients with COVID-19 showed reduced ventilatory anaerobic threshold (VAT) and peak exercise time and minute ventilation/maximum voluntary ventilation (V̇e/MVV) (all P < 0.01). Brachial endothelial function variables were all adjusted for body surface area (BSA). Patients with COVID-19 had decreased %b-FMD (3.6 vs. 5.4; P = 0.03) mean and positive flow (P = 0.02 and P = 0.03, respectively) versus controls. Adjusted linear regression models exploring associations between CPET variables, %b-FMD and the potential predictors post-COVID-19 syndrome, number of symptoms, hospitalization, and COVID severity did not detect significant associations, except for total shear rate in hospitalization (coefficient: -65.07 [95%CI -119.5;-10.5], P = 0.02). Immunocompromised and previously healthy children and adolescents with COVID-19 presented with impaired exercise capacity and endothelial dysfunction when compared with their noninfected counterparts, but the mechanisms remain unknown.NEW & NOTEWORTHY COVID-19 appeared to impair recovery of exercise capacity and endothelial function in a sample mainly comprising immunocompromised patients, but the mechanisms are unknown. These findings support the need for preventive measures against COVID-19 in this vulnerable population and suggest the necessity of proper monitoring and treatment for these patients.

Home-Based Exercise Training in the Recovery of Multisystem Inflammatory Syndrome in Children: A Case Series Study.

OBJECTIVE: To assess the potential therapeutic role of exercise on health-related quality of life, assessed by the Pediatric Outcomes Data Collection Instrument (PODCI), coronary flow reserve (CFR), cardiac function, cardiorespiratory fitness, and inflammatory and cardiac blood markers in multisystemic inflammatory syndrome in children (MIS-C) patients. METHODS: This is a case series study of a 12-wk, home-based exercise intervention in children and adolescents after MIS-C diagnosis. From 16 MIS-C patients followed at our clinic, 6 were included (age: 7-16 years; 3 females). Three of them withdrew before the intervention and served as controls. The primary outcome was health-related quality of life, assessed PODCI. Secondary outcomes were CFR assessed by 13N-ammonia PET-CT imaging, cardiac function by echocardiography, cardiorespiratory fitness, and inflammatory and cardiac blood markers. RESULTS: In general, patients showed poor health-related quality of life, which seemed to be improved with exercise. Additionally, exercised patients showed improvements in coronary flow reserve, cardiac function, and aerobic conditioning. Non-exercised patients exhibited a slower pattern of recovery, particularly in relation to health-related quality of life and aerobic conditioning. CONCLUSIONS: Our results suggest that exercise may play a therapeutic role in the treatment of post-discharge MIS-C patients. As our design does not allow inferring causality, randomized controlled trials are necessary to confirm these preliminary findings.

Physical Activity: A Strategy to Improve Antibody Response to a SARS-CoV-2 Vaccine Booster Dose in Patients With Autoimmune Rheumatic Diseases.

BACKGROUND: Physical activity associates with improved immunogenicity following a 2-dose schedule of CoronaVac (Sinovac's inactivated SARS-CoV-2 vaccine) in patients with autoimmune rheumatic diseases (ARD). This study evaluates whether physical activity impacts vaccine-induced antibody responses to a booster dose in this population. METHODS: This was a phase-4 trial conducted in São Paulo, Brazil. Patients with ARD underwent a 3-dose schedule of CoronaVac. One month after the booster, we assessed seroconversion rates of anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG, frequency of positive neutralizing antibodies, and neutralizing activity. Physical activity was assessed through questionnaire. RESULTS: Physically active (n = 362) and inactive (n = 278) patients were comparable for most characteristics; however, physically active patients were younger (P < .01) and had a lower frequency of chronic inflammatory arthritis (P < .01). Adjusted models showed that physically active patients had ∼2 times odds of seroconversion rates (OR: 2.09; 95% confidence interval, 1.22 to 3.61), ∼22% greater geometric mean titers of anti-S1/S2 IgG (22.09%; 95% confidence interval, 3.91 to 65.60), and ∼7% greater neutralizing activity (6.76%; 95% confidence interval, 2.80 to 10.72) than inactive patients. CONCLUSIONS: Patients with ARD who are physically active have greater odds of experiencing better immunogenicity to a booster dose of CoronaVac. These results support the recommendation of physical activity to improve vaccination responses, particularly for immunocompromised individuals.

No Associations Between Physical Activity and Immunogenicity in SARS-CoV-2 Seropositive Patients With Autoimmune Rheumatic Diseases Prior to and After Vaccination.

AIM: To investigate the association between physical activity and immunogenicity among SARS-CoV-2 seropositive patients with autoimmune rheumatic diseases prior to and following a 2-dose schedule of CoronaVac (Sinovac inactivated vaccine). METHODS: This was a prospective cohort study within an open-label, single-arm, phase 4 vaccination trial conducted in Sao Paulo, Brazil. In this substudy, only SARS-CoV-2 seropositive patients were included. Immunogenicity was assessed by seroconversion rates of total anti-SARS-CoV-2 S1/S2 immunoglobulin G (IgG), geometric mean titers of anti-S1/S2 IgG, frequency of positive neutralizing antibodies, and neutralizing activity before and after vaccination. Physical activity was assessed through a questionnaire. Model-based analyses were performed controlling for age (<60 or ≥60 y), sex, body mass index (<25, 25-30, and >30 kg/m2), and use of prednisone, immunosuppressants, and biologics. RESULTS: A total of 180 seropositive autoimmune rheumatic disease patients were included. There was no association between physical activity and immunogenicity before and after vaccination. CONCLUSIONS: This study suggests that the positive association between physical activity and greater antibody responses seen in immunocompromised individuals following vaccination is overridden by previous SARS-CoV-2 infection, and does not extend to natural immunity.

Food consumption based on processing level (according to Nova system) during the COVID-19 pandemic among adolescents with immunocompromised conditions: a case-control study.

The COVID-19 pandemic impacts on eating habits among adolescents may be more relevant in pediatric patients with immunocompromised chronic diseases. This case-control study conducted between June and October 2020 aimed to: (i) describe dietary patterns of adolescents with chronic conditions compared to healthy controls and (ii) determine associations between food consumption, health-related quality of life (HRQL) and sleep quality during the COVID-19 pandemic. Participants (184 immunocompromised and 58 healthy adolescents, aged 14.3 [SD 2.5]) responded to HRQL and sleep validated instruments (PedsQL and PSQI) and three 24 h food recalls via online software. Adjusted linear and logistic regressions were used to assess differences in dietary patterns and associations between food consumption (according to Nova classification) and HRQL and sleep quality. Adolescents with gastrohepatic, rheumatic, and kidney diseases had an improved dietary pattern vs. their healthy peers, showing greater consumption of unprocessed and minimally processed foods (unstandardized coefficient (b) = 7.35%[95%CI 1.59; 13.1]; b = 15.10%[95%CI 7.00; 23.1]; and b = 11.2%[95%CI 5.68; 16.8]), and lower consumption of ultraprocessed foods (b = -7.53%[95%CI-12.90; -2.18]; b = -11.4%[95%CI-18.90; -3.94]; b = -10.8%[95%CI-16.00; -5.68]). Consumption of culinary ingredients was associated with reduced psychological HRQL in controls (standardized coefficient (ß) = -0.26[95%CI-0.52; -0.004]), and processed food consumption was associated with improved sleep latency in immunocompromised participants (ß = 0.16[95%CI 0.01; 0.31]). These findings suggest diet quality may play a role in HRQL and sleep quality in this population, and may be relevant for clinical practitioners and policy makers when considering the importance of dietary quality in immunocompromised youths.

Correction: A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

[This corrects the article DOI: 10.2196/31345.].

A Rehabilitation Program for Individuals With Chronic Low Back Pain: Protocol for a Randomized Clinical Trial.

BACKGROUND: Low back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted. OBJECTIVE: We aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization. METHODS: This is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023. RESULTS: The researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023. CONCLUSIONS: Our trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31345.

In-depth cardiovascular and pulmonary assessments in children with multisystem inflammatory syndrome after SARS-CoV-2 infection: A case series study.

We assessed PET-CT myocardial blood flow (MBF) using N-13 ammonia, brachial flow-mediated dilation, and cardiopulmonary exercise test in five post-discarged MIS-C survivors. None of the patients (median age: 9, range: 7-18 years; 3 females; 2 males) had preexisting pediatric chronic conditions. At the follow-up visit, two patients exhibited severe perfusion defect developed in the left ventricular cavity, suggesting extensive myocardial ischemia (MBF <2.0) and one patient showed persistent mild pericardial effusion. Others two patients demonstrated endothelial dysfunction. Nevertheless, all patients had lower predicted values in the VO2peak , VO2VAT , OUES, and O2 Pulse (range: 35.2%-64.5%; 15.6%-38.2%; 1.0-1.3 L/min; 4-7 ml/beat), respectively. Our d suggested that previously health MIS-C patients had impaired MBF, endothelial dysfunction and lower cardiopulmonary capacity at follow-up analysis. Multidisciplinary further investigations should be conducted to reinforce these findings.

COVID-19 quarantine in adolescents with autoimmune rheumatic diseases: mental health issues and life conditions.

OBJECTIVES: To assess mental health and life conditions in adolescents with autoimmune rheumatic diseases (ARDs) and healthy controls quarantined during COVID-19 pandemic. METHOD: A cross-sectional study included 155 ARD adolescents and 105 healthy controls. Online survey included self-reported strengths and difficulties questionnaire (SDQ), and a semi-structured questionnaire with demographic data, daily home and school routine, physical activities, and COVID-19 information during the pandemic. RESULTS: Among patients, 56% had juvenile idiopathic arthritis (JIA), 29% juvenile systemic lupus erythematosus (JSLE), and 15% juvenile dermatomyositis (JDM). No differences were found regarding sex, ethnicity, and current age between ARD patients and controls (p > 0.05). Abnormal emotional SDQ (38% vs. 35%, p = 0.653) were similar in both groups. Logistic regression analyses in ARD patients demonstrated that female (OR = 2.4; 95%CI 1.0-6.0; p = 0.044) was associated with severe emotional SDQ dysfunction, whereas sleep problems were considered as a risk factor for both worse total SDQ (OR = 2.6; 95%CI 1.2-5.5; p = 0.009) and emotional SDQ scores (OR = 4.6; 95%CI 2.2-9.7; p < 0.001). Comparisons between ARD patients with and without current prednisone use showed higher median scores of peer problems in the first group [3 (0-10) vs. 2 (0-7), p = 0.049], whereas similar median and frequencies between JIA, JSLE, and JDM (p > 0.05). CONCLUSIONS: Approximately one third of JIA, JSLE, and JDM patients presented abnormal total and emotional scores of SDQ during COVID-19 quarantine. Sleep problems were the main factor associated with emotional difficulties in these ARD adolescents. The knowledge of mental health issues rates in adolescents with ARD supports the development of prevention strategies, like sleep hygiene counseling, as well as the references of the affected patients to specialized mental health services, as necessary. Key Points • One third of ARD patients presented mental health issues during COVID-19 quarantine • Sleep problems were associated with emotional difficulties. • It is necessary to warn pediatric rheumatologists about the importance of sleep hygiene counseling.

Effect of an exercise bout before the booster dose of an inactivated SARS-CoV-2 vaccine on immunogenicity in immunocompromised patients.

This randomized controlled study aimed to investigate whether a single bout of exercise before the homologous booster dose of a SARS-CoV-2 inactivated vaccine could enhance immunogenicity in patients with spondyloarthritis. We selected 60 consecutive patients with spondyloarthritis (SpA). Patients assigned to the intervention group performed an exercise bout comprising three exercises. Then, they remained at rest for 1 h before vaccination. The control group remained at rest before vaccination. Immunogenicity was assessed before (Pre) and 1 mo after (Post) the booster using seropositivity rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), frequency of neutralizing antibodies (NAb) positivity, and NAb activity. At Pre, 16 patients from the exercise group and 16 patients from the control group exhibited seropositivity for IgG (59% vs. 57.1%), and 1 mo after the booster dose, seropositivity occurred in 96% versus 100% of the cases. Only 10 patients from the exercise group and 12 patients from the control group showed positive NAb serology at Pre (37% vs. 42.8%). One month following the booster, NAb positivity was 96% versus 93%. GMT was comparable between groups at Pre. At Post, GMT increased similarly in both groups. Likewise, NAb activity was similar between groups at Pre and increased similarly in both of them as a result of the booster (47.5% vs. 39.9%). In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis.NEW & NOTEWORTHY We tested the role of exercise as an adjuvant to a booster of a COVID-19 vaccine. Immunocompromised patients were immunized after an acute bout of exercise or not. Patients exhibited an excellent immunogenicity in response to the booster dose. Exercise did not add to the vaccine effects on IgG or neutralizing antibodies.

Efficacy of home-based physical activity interventions in patients with autoimmune rheumatic diseases: A systematic review and meta-analysis.

INTRODUCTION: Physical activity (PA) has been receiving increasing interest in recent years as an adjuvant therapy for autoimmune rheumatic disease (ARDs), but there is scarce information about the efficacy of home-based PA for patients with ARDs. OBJECTIVE: To perform a systematic review and meta-analysis on the efficacy of home-based physical activity (PA) interventions in improving health-related quality of life, functional capacity, pain, and disease activity in patients with ARDs. METHODS: Searches were performed in PubMed, Web of Science, Scopus, Cochrane, CINAHL database and Sport Discus. Trials were considered eligible if they included a home-based physical activity intervention. The population included adults with autoimmune rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, idiopathic inflammatory myopathies, systemic sclerosis and ankylosing spondylitis), comparisons included non-physical activity control or centre-based interventions (i.e., interventions performed on a specialized exercise centre) and the outcomes were quality of life, pain, functional capacity, disease activity and inflammation. RESULTS: Home-based physical activity improved quality of life (p<0.01; g = 0.69; IC95%, 0.61 to 1.07) and functional capacity (p = 0.04; g = - 0.51; IC95%, -0.86; -0.16), and reduced disease activity (p = 0.03; g = - 0.60; IC95%, -1.16; -0.04) and pain (p = 0.01; g = -1.62; IC95%, -2.94 to -0.31) compared to the non-physical activity control condition. Additionally, home-based physical activity interventions were as effective as centre-based interventions for all investigated outcomes. CONCLUSION: Home-based PA is an efficacious strategy to improve disease control and aleviate symptoms in ARD.