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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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Online-Delivered Group and Personal Exercise Programs to Support Low Active Older Adults' Mental Health During the COVID-19 Pandemic: Randomized Controlled Trial.
Beauchamp, MR, Hulteen, RM, Ruissen, GR, Liu, Y, Rhodes, RE, Wierts, CM, Waldhauser, KJ, Harden, SH, Puterman, E
Journal of medical Internet research. 2021;23(7):e30709
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A widely scalable, nonpharmacological, and cost-effective approach promoted by the World Health Organization to support mental health during the pandemic corresponds to regular physical activity. The aim of this study was to assess whether a group-based online exercise programme or a personal online exercise programme compared to a waitlist control can improve the psychological health of previously low active older adults during the early stages of the COVID-19 pandemic. The study is a prospective, 3-arm, parallel, randomized controlled trial. Two-hundred and forty-one low active older adults, aged between 65 and 69 years, were enrolled in the study. Participants were stratified to ensure equal distribution of men and women across conditions. Results indicate that both physical activity programmes showed improvements in mental health when compared with control participants, which represents a notable outcome for older adults in the current COVID-19 pandemic. Authors conclude that virtually delivered interventions are feasible and, when delivered in a group setting, can aid the retention of previously low active older adults.
Abstract
BACKGROUND In response to the COVID-19 pandemic, experts in mental health science emphasized the importance of developing and evaluating approaches to support and maintain the mental health of older adults. OBJECTIVE The aim of this study was to assess whether a group-based exercise program relative to a personal exercise program (both delivered online) and waitlist control (WLC) can improve the psychological health of previously low active older adults during the early stages of the COVID-19 pandemic. METHODS The Seniors COVID-19 Pandemic and Exercise (SCOPE) trial was a 3-arm, parallel randomized controlled trial conducted between May and September 2020 in which low active older adults (aged ≥65 years) were recruited via media outlets and social media. After baseline assessments, consented participants were randomized to one of two 12-week exercise programs (delivered online by older adult instructors) or a WLC condition. A total of 241 older adults (n=187 women) provided baseline measures (via online questionnaires), were randomized (ngroup=80, npersonal=82, ncontrol=79), and completed measures every 2 weeks for the duration of the trial. The trial's primary outcome was psychological flourishing. Secondary outcomes included global measures of mental and physical health, life satisfaction, and depression symptoms. RESULTS The results of latent growth modeling revealed no intervention effects for flourishing, life satisfaction, or depression symptoms (P>.05 for all). Participants in the group condition displayed improved mental health relative to WLC participants over the first 10 weeks (effect size [ES]=0.288-0.601), and although the week 12 effect (ES=0.375) was in the same direction the difference was not statistically significant (P=.089). Participants in the personal condition displayed improved mental health, when compared with WLC participants, in the same medium ES range (ES=0.293-0.565) over the first 8 weeks, and while the effects were of a similar magnitude at weeks 10 (ES=0.455, P=.069) and 12 (ES=0.258, P=.353), they were not statistically significant. In addition, participants in the group condition displayed improvements in physical health when compared with the WLC (ES=0.079-0.496) across all 12 weeks of the study following baseline. No differences were observed between the personal exercise condition and WLC for physical health (slope P=.271). CONCLUSIONS There were no intervention effects for the trial's primary outcome (ie, psychological flourishing). It is possible that the high levels of psychological flourishing at baseline may have limited the extent to which those indicators could continue to improve further through intervention (ie, potential ceiling effects). However, the intervention effects for mental and physical health point to the potential capacity of low-cost and scalable at-home programs to support the mental and physical health of previously inactive adults in the COVID-19 pandemic. TRIAL REGISTRATION ClinicalTrials.gov NCT04412343; https://clinicaltrials.gov/ct2/show/NCT04412343.
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Metabolic impact of weight loss induced reduction of adipose ACE-2 - Potential implication in COVID-19 infections?
Li, L, Spranger, L, Soll, D, Beer, F, Brachs, M, Spranger, J, Mai, K
Metabolism: clinical and experimental. 2020;113:154401
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Obesity is now recognised as a risk factor for increased severity of Covid-19 infections. ACE-2 is a protein that has many functions but also allows Covid-19 into cells and is particularly evident in body tissues, which store fat. It is therefore possible that Covid-19 will target fat-storing tissues in the body. This 12-month randomised control weight-loss intervention study of 143 obese individuals aimed to determine ACE-2 expression and whether it could be modified by weight loss. The results showed that ACE-2 was only present in fat storing tissue and not muscle tissue. Interestingly individuals with pre-diabetes or diabetes had the lowest levels of ACE-2. Weight loss resulted in reduced ACE-2 in fat storing tissue, which resulted in an improvement in markers for diabetes. It was concluded that reduction of ACE-2 in fat storing tissues as a result of weight loss can improve markers for diabetes and could impact the severity of Covid-19 infection. Healthcare professionals could use this study to understand how weight loss in patients with obesity could decrease their risk of severe Covid-19 infection.
Abstract
BACKGROUND & AIMS Angiotensin converting enzyme (ACE)-2 is a modulator of adipose tissue metabolism. However, human data of adipose ACE-2 is rarely available. Considering that, ACE-2 is believed to be the receptor responsible for cell entry of SARS-CoV-2, a better understanding of its regulation is desirable. We therefore characterized the modulation of subcutaneous adipose ACE-2 mRNA expression during weight loss and the impact of ACE-2 expression on weight loss induced short- and long-term improvements of glucose metabolism. METHODS 143 subjects (age > 18; BMI ≥ 27 kg/m2) were analyzed before and after a standardized 12-week dietary weight reduction program. Afterwards subjects were randomized to a 12-month lifestyle intervention or a control group (Maintain-Adults trial). Insulin sensitivity (IS) was estimated by HOMA-IR (as an estimate of liver IS) and ISIClamp (as an estimate of skeletal muscle IS). ACE-2 mRNA expression (ACE-2AT) was measured in subcutaneous adipose tissue before and after weight loss. RESULTS ACE-2AT was not affected by obesity, but was reduced in insulin resistant subjects. Weight loss resulted in a decline of ACE-2AT (29.0 (20.0-47.9) vs. 21.0 (13.0-31.0); p = 1.6 ∗ 10-7). A smaller reduction of ACE-2 AT (ΔACE-2AT) was associated with a larger improvement of ISIClamp (p = 0.013) during weight reduction over 3 months, but not with the extend of weight loss. The degree of changes in insulin resistance were preserved until month 12 and was also predicted by the weight loss induced degree of ΔACE-2AT (p = 0.011). CONCLUSIONS Our data indicate that subcutaneous adipose ACE-2 expression correlates with insulin sensitivity. Weight loss induced decline of subcutaneous adipose ACE-2 expression might affect short- and long-term improvement of myocellular insulin sensitivity, which might be also relevant in the context of ACE-2 downregulation by SARS-CoV-2. TRIAL REGISTRATION ClinicalTrials.gov number: NCT00850629, https://clinicaltrials.gov/ct2/show/NCT00850629, date of registration: February 25, 2009.