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Introduction | muscle mass, sarcopenia, Sarcopenia, diabetes | SARCOPENIA, DIABETIC PERIPHERAL NEUROPATHY, COMPLICATION, SARCOPENIA, DIABETES | Diabetic peripheral neuropathy (DPN) constitutes the commonest chronic complication of diabetes (Sarcopenia features severely decreased skeletal muscle mass and strength (Measurement of muscle mass is a key factor in early screening of sarcopenia ( | PMC10160655 |
Materials and methods | PMC10160655 | |||
Study design and patients | T2DM | This cross-sectional study had approval from the Medical Ethics Committee, ShenZhen Hospital, Southern Medical University (NYSZYYEC20200030). Totally 948 T2DM patients admitted to the Department of Endocrinology, Shenzhen Hospital, Southern Medical University in April-August 2022 were enrolled. T2DM diagnosis was based on the 1999 WHO diagnostic criteria ( | PMC10160655 | |
Data collection | diabetes | DIABETES | Medical history, gender, age, height, weight, duration of diabetes and other basic indexes were collected for all patients. Body mass index (BMI) was derived as weight (kg)/height | PMC10160655 |
Muscle ultrasound examination | RFCSA was measured on both sides by ultrasound (Philips Ultrasound, WA, USA). All measurements were taken by a single ultrasound physician. Supine-positioned patients were placed with the upper body raised by 30°, legs straight and muscles relaxed. Totally 60% of the distance from the anterior superior iliac spine to the patella’s upper edge was determined ( | PMC10160655 | ||
Nerve conduction studies (NCS) | NCS | NCS were carried out with Viking Quest. Amplitudes and conduction velocities (CVs) for the median, ulnar, tibial, and peroneal complex muscle action potential (CMAP), and sensory nerve action potential (SNAP) for the median, ulnar, common peroneal, and sural nerves were measured. Mean motor nerve amplitude was derived as: Amplitude | PMC10160655 | |
Quantitative sensory tests (QST) | COLD | QST include the inspection of vibration perception threshold (VPT), warm threshold (WT) and cold threshold (CT). VPT, WT and CT were tested by the limit method in a standardized fashion (All measurements of NCS and QST parameters were performed by a single neurological technician. | PMC10160655 | |
Statistical analysis | diabetes | REGRESSION, DIABETES | Data were analyzed with SPSS 24.0 (SPSS, USA). Normally and skewedly distributed continuous data were presented by mean ± standard deviation (SD) and median with interquartile range (IQR), respectively. Between-group comparisons utilized the Student’s t test. Multiple group comparisons applied ANOVA and the Kruskal–Wallis test for data with normal and skewed distributions, respectively. Categorical data were analyzed by χ2 test. Pearson’s correlation analysis was carried out to analyze the associations of RFMI with nerve conduction parameters (mean motor or sensory nerve amplitude and CV). Multivariable logistic regression was used to analyze associations of clinical indicators with DPN. Receiver-operating characteristic (ROC) analysis was carried out to determine the optimal cutoffs of diabetes duration and RFMI for detecting DPN. P<0.05 indicated statistical significance. | PMC10160655 |
Results | PMC10160655 | |||
Baseline patient features | high-density lipoprotein, T2DM, rectus femoris mass | DIABETIC PERIPHERAL NEUROPATHY | Totally 948 diabetics aged 54.35 ± 12.71 years were included and assigned to the DPN (n=234) and non-DPN (n=714) groups (Clinical characteristics of T2DM patients with DPN versus without DPN.Values were expressed as mean ± SD for normally distributed data and median with interquartile range for non-normally distributed data, or n (%). Differences among the groups were analyzed by ANOVA for normally distributed values and by the Kruskal–Wallis test for nonparametric values. Pearson’s χ2 test was employed to analyze categorical data. *p<0.05, **p<0.001. BMI, body max index; TG, triglycerides; TC, total cholesterol; HDL, high-density lipoprotein; LDL, low-density lipoprotein; HbA1c, glycated hemoglobin; RFMI, rectus femoris mass index.In addition, patients were categorized according to RFMI by interquartile range at the cut-off points of 1.96, 2.37 and 2.81 cm²/m². Patient features in various groups are shown in Clinical characteristics of T2DM patients stratified by RFMI categories.Values were expressed as mean ± SD for normally distributed data and median with interquartile range for non-normally distributed data, or n (%). Differences among the groups were analyzed by ANOVA for normally distributed values and by the Kruskal–Wallis test for nonparametric values. Pearson’s χ2 test was employed to analyze categorical data. *p<0.05, **p<0.001. BMI, body max index; SBP, systolic blood pressure; DBP, diastolic blood pressure; BUN, blood urea nitrogen; Cr, serum creatinine; UA, serum uric acid; CysC, serum cystatin C; TG, triglycerides; TC, total cholesterol; HDL, high-density lipoprotein; LDL, low-density lipoprotein; HbA1c, glycated hemoglobin; UAER, urine albumin excretion rate; FCP, fasting c-peptide; DPN, diabetic peripheral neuropathy. | PMC10160655 |
NCS parameters in various groups based on RFMI | T2DM | NCS indexes in various groups based on RFMI are shown in Nerve conduction of T2DM patients stratified by RFMI categories.Amp, amplitude; CV, conduction velocity; *p<0.05, **p<0.001. | PMC10160655 | |
Associations of NCS indexes with RFMI in T2DM | RFMI.Amp | Pearson’s correlation analysis of RFMI and mean amplitudes/CVs of motor/sensory nerves was carried out, respectively. RFMI had significant positive correlations with mean motor nerve amplitude (r=0.244), motor nerve CV (r=0.146), sensory nerve amplitude (r=0.224) and sensory nerve CV (r=0.253), as shown in Pearson’s correlation analysis of nerve conduction with RFMI.Amp, amplitude; CV, conduction velocity. **p<0.001. | PMC10160655 | |
Risk factors for DPN | T2DM, rectus femoris mass, Diabetes, diabetes combined RFMI, diabetes | REGRESSION, DIABETES, DIABETES | For logistic regression analysis, continuous variables underwent transformation into hierarchical variates based on the following intervals: duration of diabetes (≤10 years and > 10 years), BMI (≤24 kg/mMultivariable logistic regression analysis was carried out to determine risk factors for DPN. Patient features such as diabetes duration, BMI, HbA1c and RFMI were transformed into qualitative data and used as independent variables together with gender.Diabetes duration above 10 years (OR=2.59, 95% CI1.86-3.60; P<0.001) independently predicted DPN. Additionally, low RFMI values of 1.96-2.37 cm²/m² (OR=3.57, 95% CI2.11-6.05; P<0.001) and ≤1.96 cm²/m² (OR=6.41, 95% CI3.83-10.72; P<0.001) increased the risk of DPN compared with higher levels (>2.81 cm²/m²). These data are summarized in Risk factors of DPN in multivariate logistic regression.RFMI, rectus femoris mass index;95% CI, 95% confidential interval. *p< 0.05. **p<0.001.Thus, ROC analysis was performed to assess the optimal cutoffs of T2DM duration and RFMI used jointly to detect DPN. Another multivariable logistic regression analysis was carried out with DPN as a dependent variate and T2DM duration and RFMI as independent variates. This approach enabled the assessment of the T2DM duration/RFMI combination for its predictive potential in DPN.The cutoffs for T2DM duration and RFMI were 7 years and 2.2 cm²/m², respectively; based on these values an AUC of 0.75 (95% CI: 0.72–0.79, P<0.001) was obtained, and sensitivity and specificity of 68.4% and 66.8%, respectively (Receiver-operating characteristic (ROC) analysis of the duration of diabetes combined RFMI to predict DPN in T2DM patients (AUC = 0.75; 95% CI: 0.72–0.79; sensitivity,68.4%; specificity, 66.8%, P< 0.001). | PMC10160655 |
Discussion | low RFMI, diabetes disability, death, muscle mass, neuropathy, lower limb muscle, sarcopenia, axonal degeneration of sensory/motor nerves, T2DM, demyelination, diabetes | NEUROPATHY, ANDERSEN, SARCOPENIA, REGRESSION, DEMYELINATION, DIABETES | In this study, low RFMI was found to be associated with DPN in T2DM patients, corroborating previous reports. Henning Andersen and colleagues showed that diabetics have decreased lower limb muscle volume, which has a tight association with the degree of neuropathy (Additionally, both the amplitude and CV of sensory/motor nerves declined with decreasing RFMI. Furthermore, RFMI and NCS indexes were positively correlated. These results showed that both demyelination and axonal degeneration of sensory/motor nerves are tightly correlated with sarcopenia in diabetics. Giorgio Orlando and colleagues showed that DPN affects the muscle by impairing motor nerve conduction (Besides RFMI, risk factors for DPN also encompass diabetes duration based on logistic regression, consistent with previous findings (DPN incidence is elevated in diabetics, also representing a major cause of diabetes disability and even death (In this study, ultrasound was utilized to evaluate muscle mass as a simple, non-radiative and highly operable tool, which can be easily applied in clinical and large-scale studies. Nevertheless, this study had some limitations. First, with a cross-sectional design, a causal relationship between RFMI and DPN could not be determined. Secondly, physical activity, which may be associated with muscle mass, was not assessed. | PMC10160655 |
Conclusion | low RFMI, T2DM, diabetes | DIABETES | Overall, low RFMI and DPN are significantly associated. This suggests T2DM duration and RFMI may help predict DPN prevalence. Specifically, patients with diabetes duration greater than 10 years and RFMI below 2.2 cm²/m² are closely associated with DPN. | PMC10160655 |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author. | PMC10160655 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Medical Ethics Committee, ShenZhen Hospital, Southern Medical University (NYSZYYEC20200030). The patients/participants provided their written informed consent to participate in this study. | PMC10160655 | ||
Author contributions | LW and XPL carried out the clinical studies, conducted the statistical analyses and wrote the first draft of the manuscript. HH and YW were involved in the interpretation of data. XXL and XZ contributed to the acquisition of data. LX designed the study, helped to review the manuscript and is the guarantor of this work. All authors edited, reviewed, and approved the final version of the manuscript. | PMC10160655 | ||
Acknowledgments | We thank all the participants in the study. We are indebted to our colleagues at the Department of Endocrinology in Shenzhen Hospital, Southern Medical University for their help in facilitating this study. | PMC10160655 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10160655 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10160655 | ||
References | PMC10160655 | |||
The Current Study | sexual dysfunctions, anxiety, sexual dysfunction, MDD, depression | SIDE EFFECT | The rationale of the present study was as follows: First, individuals with MDD in general, and females with MDD, more specifically, suffer from sexual dysfunctions. Second, to treat symptoms of depression SSRIs are very often prescribed, though, third, a major adverse side effect of SSRIs is to impair sexual function. Fourth, sexual functioning is considered an integral part of psychological well-being and satisfactory couple life [Following the research mentioned so far, the hypothesis was that compared to placebo, the administration of Aphrodite improved symptoms of sexual dysfunction, depression, anxiety, and sleep disturbances. | PMC10538161 |
2. Method | PMC10538161 | |||
2.1. Procedure | anxiety, sexual dysfunction, MDD, depression, SSRI-induced sexual dysfunction, sleep complaints | MAY | The current study was a randomized, double-blind, and placebo-controlled clinical trial among females with MDD and SSRI-induced sexual dysfunction, undergoing a standardized treatment with sertraline at therapeutic dosages, and assigned either to the Aphrodite or to the placebo condition. From May to July 2023, eligible females with MDD, taking sertraline for at least six weeks, and routinely treated as out-patients of the Farabi Hospital (Kermanshah, Iran) were approached to participate in the present study. After a thorough clinical interview, including the examination of inclusion and exclusion criteria (see below), participants were fully informed about the study aims and about the confidential and secure data handling. Thereafter, participants signed the written informed consent. At baseline and four and eight weeks later (study end), participants completed a series of self-rating questionnaires covering symptoms of sexual dysfunction, depression, anxiety, and sleep complaints (see below). The Review Board of Kermanshah University of Medical Sciences (Kermanshah, Iran) approved the study, which was conducted in accordance with the ethical principles in the Declaration of Helsinki and its later amendments [ | PMC10538161 |
2.2. Randomization and Sample Size Calculation | For the randomization of participants, a computer-generated random number sequence was prepared, and tickets were consecutively numbered, placed in a ballot box, and drawn by an independent researcher not further involved in the study to determine the condition of the participants.A power analysis using G*Power 3.1 [ | PMC10538161 | ||
2.3. Participants | depressive disorder | Inclusion criteria were as follows: (1) age between 18 and 50 years; (2) female gender; (3) married and self-reporting a stable long-term heterosexual relationship; (4) regular menstruation; (5) diagnosis of major depressive disorder, as ascertained by experienced psychiatrists and clinical psychologists via a thorough clinical interview [ | PMC10538161 | |
2.4. Compounds | PMC10538161 | |||
2.4.1. Aphrodite | Aphrodite tablets were purchased from Gol Daru Company (Tehran, Iran). Each tablet of Aphrodite contained ginger (12.27 mg), saffron (3 mg), cinnamon (11 mg), thistle (14 mg), and tribulus terrestris (40 mg). Two Aphrodite tablets were taken once a day in the evening. | PMC10538161 | ||
2.4.2. Placebo | Placebos consisted of farina and were provided by the same producer as the Aphrodite tablets (Gol Daru Company; Tehran, Iran). Placebo and Aphrodite tablets were identical in shape, weight, color, and scent. Both participants and staff members involved in the study were unaware of the Aphrodite or placebo assignment. As for Aphrodite, two placebo tablets were taken once a day in the evening. | PMC10538161 | ||
2.5. Measures | PMC10538161 | |||
2.5.1. Sociodemographic Information | Participants reported their age (years), anthropometric information (weight and height), civil status (married), highest educational degree (high school, bachelor and master’s), and current occupation (employment and non-employment). | PMC10538161 | ||
2.5.2. Assessing SSRI-Induced Sexual Dysfunction | psychiatric, SSRI-induced sexual dysfunction | To assess SSRI-induced sexual dysfunction, after the thorough psychiatric interview (based on a semi-structured interview [ | PMC10538161 | |
2.5.3. Sexual Functions | To assess sexual functions, participants completed the Farsi version [ | PMC10538161 | ||
2.5.4. Symptoms of Depression | depression | To assess symptoms of depression, participants completed the Farsi version [ | PMC10538161 | |
2.5.5. Symptoms of Anxiety | anxiety | To assess symptoms of anxiety, participants completed the Farsi version [ | PMC10538161 | |
2.5.6. Sleep Quality | To assess sleep quality, participants completed the Farsi version [ | PMC10538161 | ||
2.6. Statistical Analysis | PMC10538161 | |||
Statistics Were Performed per Protocol | To compare age, height, and weight between participants in the Aphrodite and placebo conditions, three independent | PMC10538161 | ||
3. Results | PMC10538161 | |||
3.3. Sexual Function | PMC10538161 | |||
3.3.1. Main Effects | Sexual functions increased over time (significant | PMC10538161 | ||
3.3.2. Post-Hoc Comparisons | Post-hoc calculations showed that within the Aphrodite condition, sexual functions scores increased from baseline to Week 4 (t (21) = −14, Post-hoc calculations comparing the groups showed that sexual function scores were similar in the Aphrodite and the placebo groups at baseline (t (39) = 0.41, | PMC10538161 | ||
3.4. Symptoms of Depression | PMC10538161 | |||
3.4.1. Main Effects | Depressive | Depressive symptoms decreased over time (significant | PMC10538161 | |
3.4.2. Post-Hoc Comparisons | depression | Post-hoc calculations showed that within the Aphrodite group, depression scores decreased from baseline to Week 4 (t (21) = 7.64, Post-hoc calculations comparing the groups showed that depression scores were similar in the Aphrodite and the placebo groups at baseline (t (39) = 0.69, | PMC10538161 | |
3.5. Symptoms of Anxiety | PMC10538161 | |||
3.5.1. Main Effects | anxiety | Symptoms of anxiety decreased over time (significant | PMC10538161 | |
3.5.2. Post-Hoc Comparisons | anxiety | Post-hoc calculations showed that within the Aphrodite group, anxiety scores decreased from baseline to Week 4 (t (21) = 9.28, Post-hoc calculations comparing the groups showed that anxiety scores were similar in the Aphrodite and the placebo groups at baseline (t (39) = −0.44, | PMC10538161 | |
3.6. Sleep Quality | PMC10538161 | |||
3.6.1. Main Effects | Sleep problems decreased over time (significant | PMC10538161 | ||
3.6.2. Post-Hoc Comparisons | Post-hoc calculations showed that within the Aphrodite group, PSQI scores decreased from baseline to Week 4 (t (21) = 4.15, Post-hoc calculations comparing the groups showed that PSQI scores were similar in the Aphrodite and the placebo groups at baseline (t (39) = 0.30, | PMC10538161 | ||
4. Discussion | The aim of the present randomized, double-blind, and placebo-controlled study was to compare the influence of Aphrodite (a blend of ginger, saffron, cinnamon, thistle, and Here, we discuss the results separately for symptoms. Further, given that we did not assess the dimensions of psychoneuroendocrine changes, we discuss the results based on previous study results. | PMC10538161 | ||
4.1. Sexual Dysfunctions | MDD, SSRI-induced sexual dysfunction | As regards sexual dysfunctions, our findings are consistent with previous studies. To illustrate, Taavoni et al. [To explain the improvement of sexual function following the consumption of Aphrodite, it appeared that the increase of testosterone was key: Gama et al. [In general, the physiological mechanism underlying the efficacy of the herbal remedy on sexual function in women is believed to be related to its impact on hormonal regulation and neurotransmitter activity such as serotonin, dopamine, and norepinephrine [Overall, the present results expand upon the current literature in that we showed that Aphrodite improved sexual function among females with MDD and SSRI-induced sexual dysfunction and compared to placebo. | PMC10538161 | |
4.2. Symptoms of Depression | depression | PATHOGENESIS | Our results showed that the Aphrodite decreased symptoms of depression as well. The physiological mechanism underlying the efficacy of herbal remedies in improving depression is believed to involve the modulation of neurotransmitter levels in the brain. Saffron contains bioactive compounds such as crocin and safranal, which are thought to enhance serotonin and dopamine levels, two neurotransmitters that play a critical role in regulating mood and emotions. By increasing the availability of these neurotransmitters, saffron may help alleviate symptoms of depression [Previous studies showed that neurotropic agents play an important role in the pathogenesis of depression as well as depression treatments [ | PMC10538161 |
4.3. Symptoms of Anxiety | neuroinflammation, anxiety, MDD, depression, SSRI-induced sexual dysfunction | OXIDATIVE STRESS | Our results showed that Aphrodite decreased the symptoms of anxiety compared to placebo. Aphrodite herbal contains bioactive compounds such as gingerol and zingerone, which have been shown to exert anxiolytic effects. These compounds are thought to interact with gamma-aminobutyric acid (GABA) receptors in the brain, leading to increased GABAergic activity. GABA is an inhibitory neurotransmitter that helps regulate anxiety and stress responses by reducing neuronal excitability [Moreover, both ginger and saffron possess antioxidant and anti-inflammatory properties, which can protect the brain from oxidative stress and neuroinflammation [Overall, the present results expand upon the current literature in that we showed that Aphrodite improved symptoms of depression and anxiety among females with MDD and SSRI-induced sexual dysfunction and compared to placebo. | PMC10538161 |
4.4. Sleep Disturbances | Aphrodite reduced sleep problems | Another part of our results showed that Aphrodite reduced sleep problems. Current evidence suggests that the neurobiological mechanism of sleep problems is associated with dysregulation of serotonergic, noradrenergic, glutamatergic, and GABAergic transmission. Saffron has also been mentioned as one of the plants effective in improving sleep. Previous studies have shown that saffron has effects on relaxation of the central nervous system [ | PMC10538161 | |
4.5. Psychiatric and Psychological Considerations | depression, sexual dysfunction, psychological distress, anxiety | Besides the neuroendocrinological models proposed above, two psychological concepts are considered to explain as to why apparently symptoms of sexual dysfunction, depression, anxiety, and sleep disturbances changed concomitantly and in parallel. The first is the concept of the transdiagnostic approach; the second is the concept of allostatic load.First, the transdiagnostic approach in psychiatry and clinical psychology [Second, the concept of allostatic load in well-being and ill-being suggests that a person per sé might not suffer (well-being) or suffer (ill-being) from psychological distress [ | PMC10538161 | |
4.6. Strengths | depression, psychiatric, anxiety | The strengths of the study are (1) the randomized, double-blind, and placebo-controlled study design, including a thorough and reliable psychiatric assessment and clearly defined inclusion and exclusion criteria; (2) the inclusion of standardized and internationally validated self-rating questionnaires; (3) the assessment of several important psychological factors such as depression, anxiety, and subjective sleep; and (4) the three time-points. | PMC10538161 | |
4.7. Limitations | behavioral health disorders like depression, anxiety | MISCARRIAGES | The novel and intriguing results of the present study should be balanced against the following limitations. First, the research was performed in one study center in Kermanshah province, and thus a systematic center-related bias cannot be excluded. Second, participants’ diet was not assessed, while in the meanwhile there is sufficient evidence that behavioral health disorders like depression and anxiety appeared to be associated with nutritional compounds such as probiotics [Given these limitations, future studies should assess both males and females, assess further psychological and neurophysiological variables, and ask about participants’ overall sexual and marital satisfaction, including marital indices such as the duration and quality of couple life. Such a thorough assessment might also include the number of children, deliveries, miscarriages, and the quality of pregnancy and delivery [ | PMC10538161 |
Author Contributions | Conceptualization, N.S. and O.D.; methodology, N.S. and O.D.; software, N.S., S.B. and O.D.; validation, N.S., S.B. and O.D.; formal analysis, A.B.B., N.S., S.B. and O.D.; investigation, N.S. and O.D.; resources, N.S. and O.D.; data curation, N.S., O.D. and S.B.; writing—original draft preparation, N.S., O.D. and S.B.; writing—review and editing, A.B.B., N.S., S.B. and O.D.; visualization, A.B.B., N.S., S.B. and O.D.; supervision, A.B.B., N.S., S.B. and O.D.; project administration, O.D.; funding acquisition, N.S. and O.D. All authors have read and agreed to the published version of the manuscript. | PMC10538161 | ||
Institutional Review Board Statement | The Review Board of Kermanshah University of Medical Sciences (Kermanshah, Iran) approved the study, which was conducted in accordance with the ethical principles in the Declaration of Helsinki and its later amendments (registration of a clinical trial: IR.KUMS.REC.1400.230). | PMC10538161 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10538161 | ||
Data Availability Statement | Data is made available to explicit experts in the field. Such experts should clearly formulate their hypotheses; further, they should fully describe, how and where they do securely store the data file, and how they make sure that the data file is not shared with and securely protected from third parties. | PMC10538161 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10538161 | ||
References | depression, anxiety, depressive symptoms | Flow chart of the number of participants, including their condition assignments.Comparisons of the Aphrodite and placebo groups from baseline, Week 4, and Week 8 for sexual functions (comparing the groups; ** Comparisons of the Aphrodite and placebo groups from baseline, Week 4, and Week 8 for depression symptoms (comparing the groups; * Comparisons of the Aphrodite and placebo groups from baseline, Week 4, and Week 8 for anxiety symptoms of anxiety (comparing the groups; * Comparisons of the Aphrodite and placebo groups from baseline, Week 4, and Week 8 for sleep quality (comparing the groups; * Descriptive statistics and overview of sociodemographic background, separately for Aphrodite and placebo at baseline.Notes: N: number, M: mean, SD: Standard deviation, cm: centimeters, Kg: kilogram.Descriptive and inferential statistical indices for sexual function, depressive symptoms, sleep quality, and anxiety at baseline at Week 4 and Week 8 and separately for the Aphrodite and control conditions.Notes: M: mean, SD: Standard deviation, * | PMC10538161 | |
Background | This study tested whether the dissonance-based | PMC10564960 | ||
Methods | eating disorders | Data were combined from three prevention trials that targeted young women at high-risk for eating disorders ( | PMC10564960 | |
Results | Peer-led | PMC10564960 | ||
Conclusions | Results support the dissemination of the peer-led | PMC10564960 | ||
Keywords | Eating disorders, reduced eating disorder symptoms, eating disorders, PD, eating disorder | Eating disorders affect 13% of females and 6% of males and result in distress, functional impairment, and elevated morbidity (Allen, Byrne, Oddy, & Crosby, Three prevention programs have significantly reduced eating disorder symptoms and onset of eating disorders (Ghaderi, Stice, Andersson, Enö Persson, & Allzén, The dual pathway model of bulimic-spectrum eating disorders (Stice & Van Ryzin, In a study examining risk factors that predicted future onset of each eating disorder type, pursuit of the thin ideal predicted future onset of BN, BED, and PD, but not future onset of AN (Stice, Gau, Rohde, & Shaw, | PMC10564960 | |
Method | PMC10564960 | |||
Participants and Procedures | We combined data from one efficacy trial [Trial 1 (completed prior to ClinicalTrials.gov); Stice et al., | PMC10564960 | ||
Design of randomized prevention trials | Psychiatric | Mailings and fliers recruited female participants for trials evaluating body acceptance interventions at high schools (Trials 1 and 3) and colleges (Trials 1 and 2). The sole inclusion criterion was that participants have body image concerns as indicated by a positive response to the question ‘Do you have body image concerns?’ (Trials 1 and 2) or ‘Are you dissatisfied with your body?’ (Trial 3). In Trial 3, all high schools in Sweden were asked to put up ads, psychology students were sent as project ambassadors to schools, and Facebook and Instagram ads were used. Participants who met criteria for DSM-IV (American Psychiatric Association, Trial 1 participants were randomized to the | PMC10564960 | |
Interventions | PMC10564960 | |||
Body Project | The | PMC10564960 | ||
Control conditions | PMC10564960 | |||
Expressive writing condition | The expressive writing condition consisted of brief written instructions sent to participants weekly over a one-month period, instructing participants to write about their thoughts, images, emotions, and whatever comes to their mind related to their body for 40 min (see Ghaderi et al., | PMC10564960 | ||
Educational video condition | Participants were asked to view | PMC10564960 | ||
Educational brochure condition | eating disorders | DISORDERS | Participants were mailed an educational brochure from the National Eating Disorders Association describing negative and positive body image, noting that negative body image is associated with increased risk for eating disorders, and offering 10 steps for achieving positive body image. Participants were also given a referral list of local mental health treatment providers with expertise in eating disorders at each assessment (see Stice et al., | PMC10564960 |
Measures | PMC10564960 | |||
Eating disorder symptoms and diagnoses | threshold/subthreshold eating disorders, self-induced vomiting, eating disorders, vomiting, weight gain, overeatingAt, depressed, eating disorder, Eating Disorder, DSM-5 | DISORDERS | Trials 1 and 2 used the semi-structured Eating Disorder Diagnostic Interview (EDDI) to assess DSM-IV eating disorder symptoms (these trials started before DSM-5 but collected data used to approximate DSM-5 criteria). Diagnostic interviews were conducted in person at baseline and over follow-up, unless the participant moved from the area or was unable to complete in-person interviews, in which case they were completed by phone. Frequency of binge eating, vomiting, laxative/diuretic use, fasting, and excessive exercise, and overvaluation of weight/shape, feeling fat, and fear of weight gain were assessed monthly over the intervals between assessments. Participants who endorsed binge eating were asked about distress regarding binge eating, rapid eating, eating until uncomfortably full, eating large quantities of food when not hungry, eating alone because of embarrassment, feeling disgusted, depressed, or guilty after overeating. We used the monthly data on eating disorder symptoms to determine when participants first met criteria for threshold/subthreshold eating disorders (operationalized in Stice et al., Trial 3 used the Eating Disorders Examination (EDE) to assess DSM-5 diagnoses of eating disorders via phone. The EDE (Fairburn & Cooper, Diagnoses were conferred using the monthly symptom data collected in interviews. Diagnostic criteria for threshold and subthreshold eating disorders used in this study, which approximate but are not identical to DSM-5 criteria, are in Diagnostic criteria for threshold and subthreshold eating disordersBMI of between 90% and 85% of that expected for age and genderDefinite fear of weight gain more than 25% of the days for at least 3 monthsWeight and shape were definitely an aspect of self-evaluationMissed one period in a three month period (unless on birth control)BMI of less than 85% of that expected for age and genderDefinite fear of weight gain more than 50% of the days for at least 3 monthsWeight and shape one of the main aspects of self-evaluationMissing menstrual cycles in a three month period (unless on birth control)At least 2 uncontrollable binge eating episodes per month for at least 3 monthsAt least 2 compensatory behavior episodes (i.e. self-induced vomiting, laxatives use, diuretic use, fasting, and excessive exercise to compensate for overeating) per month for at least 3 monthsWeight and shape was definitely an aspect of self-evaluationAt least 8 uncontrollable binge eating episodes per month for at least 3 monthsAt least 8 compensatory behavior episodes per month for at least 3 monthsWeight and shape was definitely one of the main aspects of self-evaluationAt least 2 uncontrollable binge eating episodes/days per month for at least 6 monthsLess than 1 compensatory behaviors on average per month during this periodMarked distress about binge eatingBinge eating was characterized by 3 or more of the following: rapid eating, eating until uncomfortably full, eating large amounts when not physically hungry, eating alone because of embarrassment, feeling disgusted, depressed, or guilty after overeatingAt least 8 uncontrollable binge eating episodes/days per month for at least 6 monthsLess than 1 compensatory behaviors on average per month during this periodMarked distress about binge eatingBinge eating was characterized by 3 or more of the following; rapid eating, eating until uncomfortably full, eating large amounts when not physically hungry, eating alone because of embarrassment, feeling disgusted, depressed, or guilty after overeatingAt least 8 episodes of self-induced vomiting or diuretic/laxative use for weight control purposes per month for at least 3 monthsLess than 1 uncontrollable binge eating episode on average per month during this periodWeight and shape was definitely an aspect of self-evaluation | PMC10564960 |
Statistical methods | eating disorders, eating disorder | REGRESSION | Logistic regression models tested whether the onset of each subthreshold or threshold eating disorder over follow-up was significantly lower for in-person or virtual Rates of onset of AN in this study were relatively low compared to the other eating disorders. Thus, we also conducted equivalence tests using the R package TOSTER (Version 0.3) and two one-sided test procedures (TOTS; Lakens, Scheel, & Isager, | PMC10564960 |
Results | PMC10564960 | |||
Preliminary analyses | In-person Educational video/brochure control participants did not differ in onset of subthreshold/threshold BN compared to expressive writing controls (6.2% | PMC10564960 | ||
Discussion | DSM-5, eating disorders, PD, weight gain, eating disorder, psychosocial impairment, thin-ideal, Stice | DISORDER, SECONDARY, DISORDERS | This study evaluated whether participants in the peer-led BN and PD have similar risk profiles, as several shared risk factors (i.e. thin-ideal internalization, body dissatisfaction, dietary restraint, negative affect, psychosocial impairment) and prodromal symptoms (i.e. binge eating, compensatory behaviors, weight/shape overvaluation, fear of weight gain, feeling fat) have predicted the future onset of both disorders (Stice et al., No significant difference in rates of onset of subthreshold/threshold AN emerged between peer-led The 8% reduction in subthreshold/threshold BED among Several limitations of this study should be considered. First, differences in the design of the trials that formed the current dataset (e.g. differences in control conditions and follow-up periods) likely introduced excess noise into the data. Second, the rate of onset of each of the four types of eating disorders, particularly AN, was relatively low, which reduced power. Consistent with past research of dichotomous outcomes having low incidence rates, we conducted one-tailed tests given no previous suggestion that prevention programs had iatrogenic effects. Confidence in the present results was enhanced by the secondary analyses exploring time to disorder onset, which replicated the pattern of onset effects. Third, this study involved only females, so results may not generalize to males or those who do not identify as either. Future directions include testing whether eating disorder prevention programs produce equal effects across gender and socioeconomic status. Fourth, Trials 1 and 2 occurred prior to the creation of DSM-5 but collected data that allowed us to approximate DSM-5 criteria and examine threshold and subthreshold diagnoses.Findings indicated that the peer-led | PMC10564960 |
Financial support | BLOOD, HEART, LUNG | This research was supported by National Institutes of Health Grants MH/DK061957and MH097720 awarded to ES, as well as a grant from the Swedish Foundations for Humanities and Social Sciences (Riksbankens Jubileumsfond: P14-0838:1) awarded to AG. LD receives funding from National Heart, Lung, and Blood Institute Grant T32 HL130357. | PMC10564960 | |
Conflict of interest | None. | PMC10564960 | ||
Ethical standards | The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. | PMC10564960 | ||
References | PMC10564960 | |||
Background | Parkinson’s disease, PD | Balance impairments, that lead to falls, are one of the main symptoms of Parkinson’s disease (PD). Telerehabilitation is becoming more common for people with PD; however, balance is particularly challenging to assess and treat virtually. The feasibility and efficacy of virtual assessment and virtual treatment of balance in people with PD are unknown. The present study protocol has three aims: I) to determine if a virtual balance and gait assessment (instrumented L-shape mobility test) with wearable sensors can predict a gold-standard, in-person clinical assessment of balance, the Mini Balance Evaluation Systems Test (Mini-BESTest); II) to explore the effects of 12 sessions of balance telerehabilitation and unsupervised home exercises on balance, gait, executive function, and clinical scales; and III) to explore if improvements after balance telerehabilitation transfer to daily-life mobility, as measured by instrumented socks with inertial sensors worn for 7 days. | PMC10571293 | |
Methods | PD | The TelePD Trial is a prospective, single-center, parallel-group, single-blind, pilot, randomized, controlled trial. This trial will enroll 80 eligible people with PD. Participants will be randomized at a 1:1 ratio into receiving home-based balance exercises in either: 1) balance telerehabilitation (experimental group, | PMC10571293 | |
Conclusion | PD, balance impairments | The TelePD Trial will be the first to explore the usefulness of using wearable sensor-based measures of balance and gait remotely to assess balance, the feasibility and efficacy of balance telerehabilitation in people with PD, and the translation of balance improvements after telerehabilitation to daily-life mobility. These results will help to develop a more effective home-based balance telerehabilitation and virtual assessment that can be used remotely in people with balance impairments. | PMC10571293 | |
Trial registration | This trial was prospectively registered on ClinicalTrials.gov (NCT05680597). | PMC10571293 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12883-023-03403-3. | PMC10571293 | ||
Keywords | PMC10571293 | |||
Introduction | anxiety, Parkinson’s disease, PD, insomnia, Coronavirus disease | During the Coronavirus disease (COVID-19) pandemic, millions of people were forced to self-isolate and halt regular exercise and clinical visits. Several studies recently highlighted the impact of the pandemic on people with Parkinson’s disease (PD), including worsening motor symptoms, mood, anxiety, and insomnia [Successful balance telerehabilitation requires the ability to perform both virtual assessment and virtual treatment. Balance is particularly challenging to assess virtually because a thorough and detailed in-person balance assessment typically involves measuring performance across multiple domains of balance (e.g., anticipatory postural adjustment [APA], postural sway, trunk range of motion, and turning) and with enough challenge to evoke imbalance, but this is difficult to carry out safely with virtual visits. Previous studies have demonstrated the feasibility of virtually assessing fall-related measures such as 5 times sit-to-stand [Although telerehabilitation is becoming more common for people with PD, it remains to be seen whether it is feasible and efficacious for improving balance control [Balance telerehabilitation for neurologic patients lacks strong evidence-based trials and it presents unique safety concerns [How an exercise program is delivered is important. We previously compared the Agility Boot Camp (ABC) exercise intervention executed via one-on-one, delivery with the physical therapist in the clinic versus at-home, unsupervised exercises (standard of care) [Another major focus in rehabilitation care is the advancement of using objective measures to quantify movement. Our group [The present trial has three aims: I) | PMC10571293 | |
Methods | PMC10571293 | |||
Trial design | Parkinson’s Disease | The Telerehabilitation Parkinson’s Disease (TelePD) Trial is a prospective, single-center, parallel-group, single-blind, controlled, randomized pilot trial. The study was approved by the Institutional Review Board at Oregon Health & Science University (OHSU) (eIRB #24,453) and will be conducted in accordance with the Declaration of Helsinki. This trial was prospectively registered on ClinicalTrials.gov (NCT05680597). This protocol paper follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement and guidelines. The study design is depicted in Fig. Study design. Abbreviation: ABC, Agility Boot Camp program | PMC10571293 | |
Participants and eligibility criteria | head injury, idiopathic PD, epilepsy, tremor, stroke, cognitive inability, acute illness, rigidity, PD, bradykinesia, musculoskeletal or neurological disorders, cerebellar or proprioceptive | EPILEPSY, MOVEMENT DISORDERS, STROKE, BRAIN, BRAIN DISEASE, MUSCULOSKELETAL DISORDER, CARDIAC DISEASE, VESTIBULAR PROBLEM | The target population for this study is people with PD who meet the following inclusion criteria for all aims of this trial: 1) diagnosis of idiopathic PD from a movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following—resting tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions; 2) responsive to levodopa (self-reported); 3) Hoehn & Yahr stages I-III; 4) ages 55–85 years old; 5) ability to follow directions in order to participate in testing procedures and exercise sessions, 6) free of any medical conditions or medication that contraindicates participation in an exercise program and 7) willing and able to participate in 12 sessions of rehabilitation intervention while also refraining from changes to other exercise programs and medications during the study period, within reason.Exclusion criteria are: 1) major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and balance (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease, etc.); 2) a medical condition that precludes exercise; 3) cognitive inability to participate in an exercise program, such as Montreal Cognitive Assessment score less than or equal to 19 [ | PMC10571293 |
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