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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
Abstract
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
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Efficacy of non-pharmacological interventions on executive functions in children and adolescents with ADHD: A systematic review and meta-analysis.
Qiu, H, Liang, X, Wang, P, Zhang, H, Shum, DHK
Asian journal of psychiatry. 2023;87:103692
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Attention-deficit/hyperactivity disorder (ADHD) symptoms are thought to reflect underlying executive function (EF) impairments. EFs are comprised of three core functions (viz., inhibitory control [IC], working memory [WM], and cognitive flexibility [CF]) and higher-level functions (reasoning, planning, and problem-solving). Children with ADHD commonly show developmental delays in core EFs (vs. typically developing peers) which can persist throughout individuals’ lifetimes if not treated. The aim of this study was to investigate the effects of non-pharmacological interventions on EFs in children and adolescents with ADHD. This study is a systematic review and meta-analysis of sixty-seven articles. Results showed that non-pharmacological interventions had positive moderate to large effects on overall EFs; small to moderate effects on CF, IC, WM, and planning; non-existent on reasoning skills. Authors conclude that their findings underpin the importance of non-pharmacological treatments for improving core EFs in this clinical population.
Abstract
OBJECTIVE Although front-line doctors recommend medications, this kind of treatment has limited efficacy in improving executive functions (EFs) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). This study explored the effects of non-pharmacological intervention on EFs in children and adolescents with ADHD. METHODS In accordance with the Preferred Reporting Items for Systematic Review and Meta-analyses guidelines, we searched seven electronic databases: APA PsycINFO, CINAHL Complete, EMBASE, ERIC, Medline, Pubmed, and Web of Science, from inception to March 2022. Two authors independently screened studies for eligibility, extracted data, and assessed bias risk using the Physiotherapy Evidence Database scale. Our analyses included randomized controlled trials and non-randomized comparison studies of non-pharmacological interventions and assessed EFs through neurocognitive tasks in children and adolescents between 5 and 18 years. RESULTS Sixty-seven studies with 3147 participants met the inclusion criteria. The final meta-analysis included 74 independent interventions categorized into six categories: cognitive training, EF-specific curriculum, game-based training, mindfulness practice, neurofeedback training, and physical exercise. Overall, non-pharmacological interventions (combined) produced significant moderate to large effects on overall EFs in children and adolescents with ADHD (g=0.673). Physical exercise had a large positive effect on domain-specific EFs, including inhibitory control (g=0.900) and cognitive flexibility (g=1.377). Cognitive training had a large training effect on working memory (g=0.907), and an EF-specific curriculum had a small to moderate beneficial effect on planning performance (g=0.532). CONCLUSION Non-pharmacological interventions, particularly physical exercise, cognitive training, and an EF-specific curriculum, appear to have beneficial effects on EFs in children and adolescents with ADHD.
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Causal relationship between nonalcoholic fatty liver disease and different sleep traits: a bidirectional Mendelian randomized study.
Sun, Z, Ji, J, Zuo, L, Hu, Y, Wang, K, Xu, T, Wang, Q, Cheng, F
Frontiers in endocrinology. 2023;14:1159258
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Non-alcoholic fatty liver disease (NAFLD) is caused by a build up of fat in the liver. NAFLD is becoming more common, with the rise in rates of obesity. There are no specific medications available for NAFLD and patients are advised to manage their diets and lifestyle following diagnosis. The aim of this study was to assess and evaluate the causal relationship between sleep and NAFLD. The study was a two-way Mendelian randomised clinical trial. Results showed that different sleep traits can be the cause of the onset and exacerbation of NAFLD. NAFLD does not change sleep traits and the causal relationship between them is unidirectional. Authors conclude that sleep characteristics are associated with an elevated risk of NAFLD. Thus, enhancing sleep should be considered by healthcare practitioners as part of prevention and management NAFLD.
Abstract
BACKGROUND AND AIMS Non-alcoholic fatty liver disease(NAFLD) is common worldwide and has previously been reported to be associated with sleep traits. However, it is not clear whether NAFLD changes sleep traits or whether the changes in sleep traits lead to the onset of NAFLD. The purpose of this study was to investigate the causal relationship between NAFLD and changes in sleep traits using Mendelian randomization. METHODS We proposed a bidirectional Mendelian randomization (MR) analysis and performed validation analyses to dissect the association between NAFLD and sleep traits. Genetic instruments were used as proxies for NAFLD and sleep. Data of genome-wide association study(GWAS) were obtained from the center for neurogenomics and cognitive research database, Open GWAS database and GWAS catalog. Three MR methods were performed, including inverse variance weighted method(IVW), MR-Egger, weighted median. RESULTS In total,7 traits associated with sleep and 4 traits associated with NAFLD are used in this study. A total of six results showed significant differences. Insomnia was associated with NAFLD (OR(95% CI)= 2.25(1.18,4.27), P = 0.01), Alanine transaminase levels (OR(95% CI)= 2.79(1.70, 4.56), P =4.71×10-5) and percent liver fat(OR(95% CI)= 1.31(1.03,1.69), P = 0.03). Snoring was associated with percent liver fat (1.15(1.05,1.26), P =2×10-3), alanine transaminase levels (OR(95% CI)= 1.27(1.08,1.50), P =0.04).And dozing was associated with percent liver fat(1.14(1.02,1.26), P =0.02).For the remaining 50 outcomes, no significant or definitive association was yielded in MR analysis. CONCLUSION Genetic evidence suggests putative causal relationships between NAFLD and a set of sleep traits, indicating that sleep traits deserves high priority in clinical practice. Not only the confirmed sleep apnea syndrome, but also the sleep duration and sleep state (such as insomnia) deserve clinical attention. Our study proves that the causal relationship between sleep characteristics and NAFLD is the cause of the change of sleep characteristics, while the onset of non-NAFLD is the cause of the change of sleep characteristics, and the causal relationship is one-way.
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The Emergency Medical Services Sleep Health Study: A cluster-randomized trial.
Patterson, PD, Martin, SE, Brassil, BN, Hsiao, WH, Weaver, MD, Okerman, TS, Seitz, SN, Patterson, CG, Robinson, K
Sleep health. 2023;9(1):64-76
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Severe mental and physical fatigue in shift work occupations is widespread, and workplace fatigue impacts a great majority of the Emergency Medical Services (EMS) clinician first responders. The hypothesis of this study was that education and training focused on sleep health and fatigue, delivered in an asynchronous manner and tailored to EMS shift workers, would result in improvements in sleep quality and a reduction in self-reported fatigue after a 3-month study interval. This study was a cluster-randomised, 2-arm randomised trial with a wait-list control group. EMS agencies (clusters) were randomised to either the intervention group or a wait-list control group. Results showed that intention-to-treat analyses revealed no differences in measures of sleep quality or fatigue at 3 months or 6 months follow-up. Per protocol analyses showed that the greater the number of education modules viewed, the greater the improvement in sleep quality and the greater the reduction in fatigue at 3-month follow-up. Authors conclude that the findings of this study may be useful to EMS administrators when designing fatigue risk management programmes.
Abstract
BACKGROUND Greater than half of emergency medical services (EMS) clinician shift workers report poor sleep, fatigue, and inadequate recovery between shifts. We hypothesized that EMS clinicians randomized to receive tailored sleep health education would have improved sleep quality and less fatigue compared to wait-list controls after 3 months. METHODS We used a cluster-randomized, 2-arm, wait-list control study design (clinicaltrials.gov identifier: NCT04218279). Recruitment of EMS agencies (clusters) was nationwide. Our study was powered at 88% to detect a 0.4 standard deviation difference in sleep quality with 20 agencies per arm and a minimum of 10 individuals per agency. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up. Our intervention was accessible in an online, asynchronous format and comprised of 10 brief education modules that address fatigue mitigation topics prescribed by the American College of Occupational Environmental Medicine. RESULTS In total, 36 EMS agencies and 678 individuals enrolled. Attrition at 3 months did not differ by study group (Intervention = 17.4% vs. Wait-list control = 18.2%; p = .37). Intention-to-treat analyses detected no differences in PSQI and fatigue scores at 3 months. Per protocol analyses showed the greater the number of education modules viewed, the greater the improvement in sleep quality and the greater the reduction in fatigue (p < .05). CONCLUSIONS While intention-to-treat analyses revealed no differences in sleep quality or fatigue at 3 months, per protocol findings identified select groups of EMS clinician shift workers who may benefit from sleep health education. Our findings may inform fatigue risk management programs.
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Effect of Sleep Changes on Health-Related Quality of Life in Healthy Children: A Secondary Analysis of the DREAM Crossover Trial.
Taylor, RW, Haszard, JJ, Jackson, R, Morrison, S, Beebe, DW, Meredith-Jones, KA, Elder, DE, Galland, BC
JAMA network open. 2023;6(3):e233005
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While inadequate or poor-quality sleep has been associated with a wide range of adverse physical and psychological health outcomes in infants, children and adolescents, interest is growing regarding the association of sleep with more global indices of health, such as health-related quality of life (HRQOL). The aim of this study was to determine the effect of mild sleep deprivation on HRQOL in children without major sleep issues. This study was a secondary analysis based on the DREAM randomised crossover trial. Children were randomised to one of two groups (sleep restriction or sleep extension) with a 1-week washout in between. Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. Results showed that after only 1 week of receiving 39 minutes less sleep per night between sleep conditions, children reported significantly lower HRQOL in terms of their physical and overall well-being and ability to cope well at school. Authors conclude that ensuring children receive sufficient good-quality sleep is an important child health issue.
Abstract
IMPORTANCE Little is known regarding the effect of poor sleep on health-related quality of life (HRQOL) in healthy children. OBJECTIVE To determine the effect of induced mild sleep deprivation on HRQOL in children without major sleep issues. DESIGN, SETTING, AND PARTICIPANTS This prespecified secondary analysis focused on HRQOL, a secondary outcome of the Daily Rest, Eating, and Activity Monitoring (DREAM) randomized crossover trial of children who underwent alternating weeks of sleep restriction and sleep extension and a 1-week washout in between. The DREAM trial intervention was administered at participants' homes between October 2018 and March 2020. Participants were 100 children aged 8 to 12 years who lived in Dunedin, New Zealand; had no underlying medical conditions; and had parent- or guardian-reported normal sleep (8-11 hours/night). Data were analyzed between July 4 and September 1, 2022. INTERVENTIONS Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. MAIN OUTCOMES AND MEASURES All outcome measures were assessed during both intervention weeks. Sleep timing and duration were assessed using 7-night actigraphy. Children and parents rated the child's sleep disturbances (night) and impairment (day) using the 8-item Pediatric Sleep Disturbance and 8-item Sleep-Related Impairment scales of the Patient-Reported Outcomes Measurement Information System questionnaire. Child-reported HRQOL was assessed using the 27-item KIDSCREEN questionnaire with 5 subscale scores and a total score. Both questionnaires assessed the past 7 days at the end of each intervention week. Data were presented as mean differences and 95% CIs between the sleep restriction and extension weeks and were analyzed using intention to treat and an a priori difference in sleep of at least 30 minutes per night. RESULTS The final sample comprised 100 children (52 girls [52%]; mean [SD] age, 10.3 [1.4] years). During the sleep restriction week, children went to sleep 64 (95% CI, 58-70) minutes later, and sleep offset (wake time) was 18 (95% CI, 13-24) minutes later, meaning that children received 39 (95% CI, 32-46) minutes less of total sleep per night compared with the sleep extension week in which the total sleep time was 71 (95% CI, 64-78) minutes less in the per-protocol sample analysis. Both parents and children reported significantly less sleep disturbance at night but greater sleep impairment during the day with sleep restriction. Significant standardized reductions in physical well-being (standardized mean difference [SMD], -0.28; 95% CI, -0.49 to -0.08), coping in a school environment (SMD, -0.26; 95% CI, -0.42 to -0.09), and total HRQOL score (SMD, -0.21; 95% CI, -0.34 to -0.08) were reported by children during sleep restriction, with an additional reduction in social and peer support (SMD, -0.24; 95% CI, -0.47 to -0.01) in the per-protocol sample analysis. CONCLUSIONS AND RELEVANCE Results of this secondary analysis of the DREAM trial indicated that even 39 minutes less of sleep per night for 1 week significantly reduced several facets of HRQOL in children. This finding shows that ensuring children receive sufficient good-quality sleep is an important child health issue. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12618001671257.
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Does providing feedback and guidance on sleep perceptions using sleep wearables improve insomnia? Findings from "Novel Insomnia Treatment Experiment": a randomized controlled trial.
Spina, MA, Andrillon, T, Quin, N, Wiley, JF, Rajaratnam, SMW, Bei, B
Sleep. 2023;46(9)
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Insomnia involves difficulties with initiating sleep, maintaining sleep and early morning awakenings. Sleep–wake state discrepancy is a common phenomenon observed in 9%–50% of individuals with insomnia. In fact, sleep–wake state discrepancy is important to explore as it is linked to daytime functioning, self-reported happiness, social support and self-reported sleep. The primary aim of this study was to examine whether providing individuals with insomnia feedback about sleep using wearable devices, along with support for appropriate interpretation of sleep–wake state discrepancy, improves symptoms of insomnia as the primary outcome. This study was a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Eligible participants were randomised 1:1 to intervention or control groups. Results showed that the intervention group had lower insomnia symptom severity and sleep disturbance and lower rates of insomnia disorder. However, the two groups did not meaningfully differ on all other secondary and exploratory outcomes at post-intervention. Authors conclude that addressing sleep–wake state discrepancy by providing education and guidance on wearable measured sleep data could reduce symptoms of insomnia. Additionally, future studies need to examine how sleep–wake state discrepancy guidance using wearable devices could supplement cognitive behavioural therapy for insomnia (CBT-I), and whether this addition could enhance the benefits of CBT-I.
Abstract
STUDY OBJECTIVES Insomnia is a disorder diagnosed based on self-reported sleep complaints. Differences between self-reported and sensor-based sleep parameters (sleep-wake state discrepancy) are common but not well-understood in individuals with insomnia. This two-arm, parallel-group, single-blind, superiority randomized-controlled trial examined whether monitoring sleep using wearable devices and providing support for interpretation of sensor-based sleep data improved insomnia symptoms or impacted sleep-wake state discrepancy. METHODS A total of 113 (age M = 47.53; SD = 14.37, 64.9% female) individuals with significant insomnia symptoms (Insomnia Severity Index(ISI) ≥10) from the community were randomized 1:1 (permuted block randomization) to receive 5 weeks (1) Intervention (n = 57): feedback about sensor-based sleep (Fitbit and EEG headband) with guidance for data interpretation and ongoing monitoring, and (2) Control (n = 56): sleep education and hygiene. Both groups received one individual session and two check-in calls. The ISI (primary outcome), sleep disturbance (SDis), sleep-related impairment (SRI), depression, and anxiety were assessed at baseline and post-intervention. RESULTS In total, 103 (91.2%) participants completed the study. Intention-to-treat multiple regression with multiple imputations showed that after controlling for baseline values, compared to the Control group (n = 51), the Intervention group (n = 52) had lower ISI (p = .011, d = 0.51) and SDis (p = .036, d = 0.42) post-intervention, but differences in SRI, depression, anxiety, and sleep-wake state discrepancy parameters (total sleep time, sleep onset latency, and wake after sleep onset) were not meaningful (P-values >.40). CONCLUSIONS Providing feedback and guidance about sensor-based sleep parameters reduced insomnia severity and sleep disturbance but did not alter sleep-wake state discrepancy in individuals with insomnia more than sleep hygiene and education. The role of sleep wearable devices among individuals with insomnia requires further research. CLINICAL TRIAL REGISTRATION The Novel Insomnia Treatment Experiment (NITE): the effectiveness of incorporating appropriate guidance for sleep wearables in users with insomnia. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378452, Australia New Zealand Clinical Trials Registry: ACTRN12619001636145.
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Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.
Tantrakul, V, Ingsathit, A, Liamsombut, S, Rattanasiri, S, Kittivoravitkul, P, Imsom-Somboon, N, Lertpongpiroon, S, Jantarasaengaram, S, Somchit, W, Suwansathit, W, et al
Respiratory research. 2023;24(1):171
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Preeclampsia is a leading cause of maternal and foetal morbidity and mortality. Obstructive sleep apnoea (OSA) during pregnancy has been identified as a risk factor for preeclampsia and gestational hypertension. Although continuous positive airway pressure (CPAP) is a standard treatment for OSA in the general population, there is limited data regarding the efficacy and safety of CPAP treatment during pregnancy. The aim of this study was to evaluate the efficacy of CPAP treatment in high-risk pregnancy with mild-to-moderate OSA in reducing BP and hypertensive disorders in pregnancy. This study was a multicentre, open-label, parallel-group randomised controlled trial. Pregnant women attending antenatal care at all collaborating hospitals were recruited. Results showed that CPAP significantly reduced blood pressure (BP), with larger effects on diastolic BP and mean arterial pressure than systolic BP. Furthermore, it reduced the incidence of preeclampsia and hypertensive disorders in pregnancy. Authors conclude that their findings raise the need for early diagnosis and treatment of OSA in high-risk pregnancies.
Abstract
BACKGROUND Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA. METHODS A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence. RESULTS Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21). CONCLUSIONS CPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.
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Hypnotherapy, Intermittent Fasting, and Exercise Group Programs in Atopic Dermatitis: A Randomized Controlled Explorative Clinical Trial During the COVID-19 Pandemic.
Rotter, G, Teut, M, Schleicher, R, Dell'Oro, M, Ortiz, M, Binting, S, Tissen-Diabaté, T, Roll, S, Michalsen, A, Staab, D, et al
Journal of integrative and complementary medicine. 2023;29(2):99-110
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Relaxation techniques, diet, and exercise can diminish atopic dermatitis (AD) symptoms. Patients with AD worry about the side-effects of the medical treatment for AD thus the majority try to engage in potentially healthy lifestyle behaviours. The aim of this study was to exploratively investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in adult AD patients This study is a four-armed, randomised controlled, single-centre, open explorative clinical trial. Patients were randomly assigned to one of the four groups: i) hypnotherapy group program (HTP), ii) intermittent fasting with diet adjustment group program (IFDP), iii) an exercise group program or the control group. The study was strongly impacted by confinements and research restrictions due to the coronavirus 2019 pandemic. However, results showed potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Authors conclude that further high-quality clinical trials should be performed investigating the effectiveness and safety of hypnotherapy, fasting with diet adjustments, as well as exercise.
Abstract
Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.
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The effects of home-based exercise therapy for breast cancer-related fatigue induced by radical radiotherapy.
Mavropalias, G, Cormie, P, Peddle-McIntyre, CJ, Galvão, DA, Taaffe, DR, Schofield, C, Ray, S, Zissiadis, Y, Newton, RU
Breast cancer (Tokyo, Japan). 2023;30(1):139-150
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Breast cancer (BCa) is the most common form of cancer among women. Radiotherapy (RT) treatment is an important component of breast cancer treatment and is used with curative intent as well as for palliation. One commonly reported adverse side effect of RT is cancer related fatigue (CRF). The aims of this study were to (a) examine the effects of a 12-week home-based resistance and aerobic exercise program on CRF, health-related quality of life (HRQoL), and sleep quality and duration in BCa patients during and up to 12 months after RT, and (b) investigate how CRF, HRQoL, and sleep quality and duration affect the participants’ ability to follow their prescribed exercise program. This study was a two-arm, randomised controlled clinical trial. One hundred and six (n = 106) women with stage I-III BCa scheduled to receive radical RT were randomised into exercise (n = 51) or usual care (n = 55). Results show that CRF was present at baseline and persisted during RT. The exercise group had a quicker reduction in CRF compared to the usual care group. Moreover, there was a significant difference in the HRQoL during RT between groups, and a quicker HRQoL improvement post-RT for the exercise group, with no changes in sleep quality or duration. Additionally, less fatigue and less trouble sleeping were associated with greater weekly aerobic exercise duration and higher rating of perceived exertion during aerobic exercise. Authors conclude that home-based exercise during RT is safe and effective in reducing CRF and improving HRQoL
Abstract
BACKGROUND Radiotherapy (RT) can lead to cancer-related fatigue (CRF) and decreased health-related quality of life (HRQoL) in breast cancer patients. The purpose of this trial was to examine the feasibility and efficacy of a home-based resistance and aerobic exercise intervention for reducing CRF and improving HRQoL in breast cancer patients during RT. METHODS Women with breast cancer (N = 106) commencing RT were randomized to 12 weeks of home-based resistance and aerobic exercise (EX) or usual care/control (CON). The primary endpoint was CRF, with secondary endpoints of HRQoL, sleep duration and quality, and physical activity. Measurements were undertaken prior to RT, at completion of RT (~ 6 weeks), at completion of the intervention (12 weeks), and 6 and 12 months after RT completion, while CRF was also measured weekly during RT. RESULTS Eighty-nine women completed the study (EX = 43, CON = 46). Over the 12-week intervention, EX completed 1-2 resistance training sessions and accumulated 30-40 min of aerobic exercise weekly. For CRF, EX had a quicker recovery both during and post-RT compared to CON (p < 0.05). Moreover, there was a significant difference in HRQoL between groups at RT completion, with HRQoL unchanged in CON and higher in EX (p < 0.05). There was no change in sleep duration or quality for either group and there were no exercise-related adverse effects. CONCLUSIONS Home-based resistance and aerobic exercise during RT is safe, feasible, and effective in accelerating CRF recovery and improving HRQoL. Improvements in CRF and HRQoL for these patients can be achieved with smaller exercise dosages than stated in the generic recommendations for breast cancer.
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Improving stress management, anxiety, and mental well-being in medical students through an online Mindfulness-Based Intervention: a randomized study.
Fazia, T, Bubbico, F, Nova, A, Buizza, C, Cela, H, Iozzi, D, Calgan, B, Maggi, F, Floris, V, Sutti, I, et al
Scientific reports. 2023;13(1):8214
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Medical students commonly experience anxiety, depression, burnout and emotional discomfort due to the pressures of medical school. This randomised, controlled study of 362 medical students at Italian Universities evaluated the effectiveness of a 5-week online mindfulness-based intervention (MBI), consisting of an introductory session, 8 sessions of 35 min integral meditation and 10 min yoga, and one dietary advice/question and answer session with a nutritionist. The control group received no intervention. Effectiveness was measured through a variety of validated questionnaires for perceived stress, anxiety, wellbeing, emotional health, resilience and cognition. Overall, at baseline, participants of this study fared worse for stress than other studies had shown for general populations. The MBI was effective in improving perceived stress, mental wellbeing, emotional regulation, resilience, tendency to mind-wandering, ability to maintain attention and overall distress, although effect sizes for all outcomes were small. No statistically significant effect was seen for the anxiety rating. Interestingly, two cohorts were included in this study and whilst one benefitted from the programme, the other did not, one explanation of which may be that they were done during different phases of the COVID pandemic. The authors conclude that adopting MBI may help improve students’ wellbeing.
Abstract
Pressures and responsibilities of medical school put a strain on medical student's personal wellbeing, leading among all to high rates of anxiety, emotional discomfort and stress. In this work we evaluated the effectiveness of a comprehensive Mindfulness-Based Intervention (MBI) in reducing this load. The intervention comprised 10 twice-a-week Integral Meditation classes, dietary advice, and brief yoga sessions. We performed a randomized trial on two cohort of medical students from Italian universities: 239 in cohort 1 (106 treated and 133 controls), and 123 in cohort 2 (68 treated and 55 control) for a total sample of 362 students. Nine questionnaires for evaluating the effectiveness of our intervention on stress (PSS), state anxiety (STAIX-1), well-being (WEMWBS), mind-wandering (MW-S), overall distress (PANAS), emotion regulation (DERS), resilience (RS-14), and attentional control (ACS-C and ACS-D) were collected both pre and post intervention. Linear mixed effect models were run on the whole sample showing that, after multiple testing correction, our intervention was effective in reducing perceived stress (β = - 2.57 [- 4.02; - 1.12], p = 0.004), improving mental well-being (β = 2.82 [1.02; 4.63], p = 0.008) and emotional regulation (β = - 8.24 [- 12.98; - 3.51], p = 0.004), resilience (β = 3.79 [1.32; 6.26], p = 0.008), reducing the tendency to wander with the mind (β = - 0.70 [- 0.99; - 0.39], p = 0.0001), ameliorating the ability to maintain attention (AC-S (β = - 0.23 [- 0.44; - 0.02], p = 0.04) and AC-D (β = - 0.19 [- 0.36; - 0.01], p = 0.04)), and the overall distress (β = 1.84 [0.45; 3.23], p = 0.02).