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2.1. Study Design | aggression, irritability, DSM-5 | This 12-week open-label pilot study was conducted to investigate the efficacy of glutathione use as a supplement for the symptomatic treatment of irritability and aggression in children with ASD, as defined by criteria set forth in the DSM-5. Trials were conducted in the outpatient setting at the University of Chicago.... | PMC10660524 | |
2.2. Inclusion and Exclusion Criteria | myocardial infarction, seizures, neoplasia, anemia, hematological disorders, milk thistle, asthma, unstable medical illness, DSM-5 | MYOCARDIAL INFARCTION, COAGULOPATHIES, NEOPLASIA, ANEMIA, HEMATOLOGICAL DISORDERS, ASTHMA | Inclusion criteria included the following: (a) children and adolescents of both sexes between ages 4–17; (b) diagnosis of ASD as determined by criteria set forth in DSM-5 (Exclusion criteria included the following: (a) unstable medical illness or clinically significant abnormalities on physical examination; (b) history... | PMC10660524 |
2.3. Interventions | SRS | Subjects were followed over a 12-week course with an initial intake appointment for baseline screening of vital signs, oxidative laboratory work, Social Responsiveness Scale, Aberrant Behavior Checklist, and Clinical Global Impression scale. The use of oral glutathione was discussed with subjects and their parents who ... | PMC10660524 | |
2.4. Outcome Measures | SECONDARY | Our primary outcome was to monitor therapeutic efficacy of glutathione in treating symptoms of ASD in children. Our secondary outcome was to evaluate the tolerability of oral glutathione in children with ASD. The following scales and checklists were used for the goals of the study. | PMC10660524 | |
2.4.1. Oxidative Labs | OXIDATIVE STRESS, OXIDATIVE STRESS | Subjects underwent laboratory studies to assess oxidative burden pre- and post-treatment during the study period. Oxidative Stress Analysis 2.0 was performed by Geneva Diagnostics and included a battery of tests to quantify oxidative stress. Specifically, this panel looks at (I) reduction–oxidation reserve including gl... | PMC10660524 | |
2.4.2. Aberrant Behavior Checklist (ABC) | lethargy, epilepsy, hyperactivity, agitation, irritability, ASD, intellectual disability, developmental disabilities | SECONDARY, EPILEPSY | This is 58-item symptom checklist that assesses behavioral problems in adults and children with developmental disabilities including ASD, intellectual disability, epilepsy, etc. The checklist is a versatile assessment tool that can be used in a variety of settings including home, community settings, educational setting... | PMC10660524 |
2.4.3. Social Responsiveness Scale (SRS) | autism mannerisms, deficit in social interaction, SRS | This scale is a respondent-based outcome measure used to assess deficits and symptoms related to ASD. The scale comes in two forms differentiated by gender and age. The scale can be administered by parents/caregivers and consists of subscales that assess (I) social awareness; (II) social cognition; (III) social communi... | PMC10660524 | |
2.4.4. Clinical Global Impressions (CGI) Scale | ill | ADVERSE EVENTS | This brief, 3-item assessment tool provides a global rating of illness severity (CGI-S), global improvement or change (CGI-I), and therapeutic efficacy (CGI-E). CGI-S is measured on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). CGI-I is measured on a 7-point scale... | PMC10660524 |
2.4.5. Side Effect Checklist (SEC) | SIDE EFFECT | This in-house glutathione side effect questionnaire ( | PMC10660524 | |
2.5. Statistical Analyses | The CGI severity scale was used to assess clinically significant change after treatment. For someone to have a clinically significant change, her or his final CGI severity score had to be less than the cutoff score, and his or her change from baseline had to be greater than the reliable change index. The statistical si... | PMC10660524 | ||
3. Results | PMC10660524 | |||
3.1. Study Population | autism spectrum disorder, DSM-5 | After screening the potential subjects for the inclusion and exclusion criteria, this pilot study recruited a total of six subjects, all of whom met DSM-5 criteria for a diagnosis of autism spectrum disorder. Parental consent was obtained for each participant during enrollment prior to the study. The demographics of th... | PMC10660524 | |
3.2. Oxidative Stress Analysis | OXIDATIVE STRESS, STD | The participants all underwent baseline oxidative stress screening prior to glutathione treatment and post-glutathione treatment upon completion of the study where appropriate. One patient was unable to complete the full study and did not undergo the post-treatment oxidative stress screen. The results of the oxidative ... | PMC10660524 | |
3.3. Behavioral Outcomes | SRS | The ASD severity was measured using SRS. All subjects underwent SRS screening during the initial enrollment, with the results outlined in ABC was another scale used to track the ASD treatment progress with oral glutathione supplementation. The pre- and post-treatment subscores in five different domains are outlined in | PMC10660524 | |
3.4. Safety Evaluation | ADVERSE EFFECTS | Oral glutathione supplementation was generally well-tolerated throughout the course of the study. There were minimal adverse effects reported, as summarized in The CGI scale was also used as a tool to measure the improvement with oral glutathione supplementation; the results are summarized in | PMC10660524 | |
4. Discussion | ASD and gastrointestinal abnormalities, mitochondrial dysfunction, irritability, psychiatric | SIDE EFFECT, STOMACH, CYSTIC FIBROSIS, MITOCHONDRIAL DYSFUNCTION, OXIDATIVE STRESS | Our pilot investigation examined the utility and tolerability of oral supplementation with glutathione as a treatment for patients with ASD. A similar study by Kern et al. looked at glutathione supplementation for the treatment of ASD. Kern et al. demonstrated the safety profile of oral glutathione supplementation and ... | PMC10660524 |
Author Contributions | Conceptualization: K.R. and K.B.-W.; methodology: K.R. and K.B.-W., software: G.W.; formal analysis: G.W.; investigation: K.R., K.B.-W. and R.R., resources, K.R.; data curation: G.W.; writing: K.R. and G.W.; writing—review and editing: K.R. and K.B.-W., visualization: G.W. and K.R., supervision: K.R., project administr... | PMC10660524 | ||
Institutional Review Board Statement | The study was approved by the University of Chicago BSD IRB # IRB 19-0017. | PMC10660524 | ||
Informed Consent Statement | Informed written consent was obtained from all subjects involved in the study. | PMC10660524 | ||
Data Availability Statement | The study is registered with the clincialtrials.gov. | PMC10660524 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10660524 | ||
Appendix A. Diagnostic Criteria | intellectual developmental disorder, verbal nonverbal behavior, repetitive motor movements, Intellectual disability, Asperger’s disorder, autistic disorder, communication disorder, intellectual disability, catatonia, hyporeactivity, autism spectrum disorder, deficits in social communication, DSM-5 | DISORDER, GENETIC CONDITION, DISORDERS | The following diagnostic criteria for ASD will be utilized. The criteria are defined by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) for a diagnosis of autism spectrum disorder:Persistent deficits in social communication and social interaction across multiple contexts, as manifested by the followi... | PMC10660524 |
Appendix B | SIDE EFFECT | Glutathione Side Effect Questionnaire. | PMC10660524 | |
References | SE, GS, SAH | SIDE EFFECTS | Glutathione redox cycle. Glutathione is primarily synthesized in the liver. Oxidized glutathione (GSSG) is then reduced via glutathione reductase and nicotinamide adenine dinucleotide phosphate (NADPH) into reduced glutathione (GSH). GSH is a major antioxidant in the body that primarily acts to eliminate reactive oxyge... | PMC10660524 |
INTRODUCTION: | IBS | IRRITABLE BOWEL SYNDROME (IBS) | Delivered in person, yoga is effective in managing irritable bowel syndrome (IBS) symptoms. The evidence for efficacy, feasibility, and safety of virtually delivered yoga for patients with IBS is unknown. | PMC9889201 |
METHODS: | IBS, depression, fatigue, anxiety | ADVERSE EVENTS, SECONDARY, RECRUITMENT | Adults diagnosed with IBS were randomized to either Hatha yoga intervention of 8 weekly online classes delivered virtually or an advice-only control group and assessed at baseline and postintervention. We used an unadjusted ANOVA to determine differences between and within groups on the primary outcome (decrease of ≥50... | PMC9889201 |
RESULTS: | Seventy-nine people participated (mean age 45.4 years [SD = 14.0], 92% women, 20% attrition rate). IBS-SSS decreased significantly in the treatment group (Δ | PMC9889201 | ||
DISCUSSION: | IBS | Virtually delivered yoga is safe and feasible, and effective in reducing IBS symptoms. Based on the primary end point, the intervention was not superior to an advice-only control group. | PMC9889201 | |
INTRODUCTION | MY-IBS, IBS, psychiatric, fatigue | IRRITABLE BOWEL SYNDROME, IRRITABLE BOWEL SYNDROME | Irritable bowel syndrome (IBS) is a common chronic condition frequently involving alterations of the gut-brain axis. IBS is associated with psychiatric comorbidities, incomplete symptom control, and impaired quality of life (QOL) (Yoga is a mind-body therapy that includes physical postures (asanas), breathing exercises... | PMC9889201 |
METHODS | PMC9889201 | |||
Study design overview | IBS | INFLAMMATION | MY-IBS was a randomized 2-group controlled trial conducted at the University of Calgary in Alberta, Canada, from March 2021 to December 2022. Participants were not blinded to trial arms. Eligible participants diagnosed with IBS based on Rome IV (Individuals across Canada were eligible to participate. Participants were ... | PMC9889201 |
Interventions | PMC9889201 | |||
Yoga intervention group. | The details of the yoga program have been published elsewhere ( | PMC9889201 | ||
Advice-only control group. | IBS | Control participants received a 10-minute video including general education on IBS, the mind-gut connection in IBS, and the role of mind-body therapies in the management of IBS. These participants also received a list of IBS-related resources from the Canadian Digestive Health Foundation, a link to an IBS patient suppo... | PMC9889201 | |
Outcome measures | PMC9889201 | |||
Efficacy outcomes. | IBS, cancer | CANCER, DISEASE | The intervention and control groups were assessed on efficacy outcomes at baseline and 8 weeks. The primary end point measure was at least a 50-point difference on the IBS Symptom Severity Scale (IBS-SSS) between the groups postintervention (Secondary outcomes (and their measures) include QOL (IBS-QOL) (The Theory of P... | PMC9889201 |
Sample size | Symptom reduction of at least 50 points on the IBS-SSS is considered clinically meaningful ( | PMC9889201 | ||
Randomization, treatment allocation, and blinding | Participants were randomized after baseline assessment to either the yoga intervention or the advice-only control group. A statistician blinded to the randomization key created a computer-generated REDCap randomized sequence to allocate participants. Participants were aware of the group to which they were allocated. Th... | PMC9889201 | ||
Data analysis | REGRESSION, SECONDARY | Participant characteristics and feasibility metrics for both treatment and control groups as well as program adherence for the treatment group only were summarized using descriptive statistics. Fisher exact tests examined baseline differences between groups for categorical variables. Percentages were calculated to dete... | PMC9889201 | |
RESULTS | PMC9889201 | |||
Participant characteristics | A total of 142 patients expressed interest in participating and 63 were excluded (see Figure Participant flowchart based on the CONSORT guidelines.Participant baseline sociodemographic characteristics by group (N = 79) | PMC9889201 | ||
Primary outcome. | SECONDARY | The sample mean IBS-SSS was moderate at 245.3 (196.5–317.0, SD = 86.6) points at baseline and 207.9 (117.0–270.0, SD = 100.2) at week 8. The percentage of patients meeting the ≥50-point decrease in IBS-SSS postintervention (8 weeks) was 37% (n = 14) in the yoga group compared with 20% (n = 8) in the control group (With... | PMC9889201 | |
Subgroup exploratory analysis of responders. | Twenty-two patients were included in the responder analysis (14 [51.8%] and 8 [22.2%]) (i.e., responders in the treatment and control groups). The difference between the groups was nonsignificant (Changes in outcome measures for treatment and control groups among responders (n = 22)Determinants of response (variables w... | PMC9889201 | ||
Secondary outcomes. | fatigue | Using intent-to-treat analysis, we observed between-group differences postintervention favoring the treatment group for QOL, fatigue, and perceived stress (Table | PMC9889201 | |
Previous yoga experience and intention to do yoga | Most participants had tried yoga in the past. Intention to do yoga was 6.5 (SD = 0.7) at baseline and 4.0 (SD = 1.8) at 8 weeks for the treatment group and 6.5 (SD = 0.6) at baseline and 5.2 (SD = 1.7) at 8 weeks for the control group. There was a significant change in proportions of intention to do yoga from baseline ... | PMC9889201 | ||
Feasibility outcomes | IBS | EVENTS | The attrition rate was 20% (29% and 12% in the treatment and control groups, respectively). In the treatment group, 7 of 11 participants were randomized to the intervention but did not start the program, 2 participants withdrew because of changing work schedules, 1 participant was hospitalized for a non–IBS-related con... | PMC9889201 |
DISCUSSION | IBS, depression, fatigue, anxiety | The MY-IBS study is the first to demonstrate the feasibility and safety of an 8-week virtual yoga program combined with the home-based practice for patients with IBS compared with an advice-only control group. The sample had moderate IBS symptom severity at baseline. Significant within-group improvements in IBS symptom... | PMC9889201 | |
Strengths and limitations | IBS, depression | ADVERSE EVENTS, RECRUITMENT | This study is the first to evaluate the efficacy and feasibility of a virtual yoga intervention. The yoga intervention was developed based on IBS mechanistic rationale supported by an international yoga foundation and delivered by an experienced yoga instructor and at-home practice was supported by videos. We recruited... | PMC9889201 |
Study Highlights | PMC9889201 | |||
REFERENCES | PMC9889201 | |||
ABSTRACT | PMC10539208 | |||
Background | fracture | LOW BONE MINERAL DENSITY, VITAMIN K DEFICIENCY | Vitamin K deficiency is highly prevalent in patients on dialysis and may contribute to their low bone mineral density (BMD) and increased risk of fracture. This study investigated the effect of menaquinone-7 (MK-7) supplementation on BMD in patients on chronic dialysis. | PMC10539208 |
Methods | In a multicentre, double-blind, placebo-controlled intervention trial, 123 patients on chronic dialysis were randomised to a daily oral supplement of either MK-7 360 µg or placebo for 2 years. BMD of the distal radius (1/3, mid, ultradistal and total), femoral neck, lumbar spine (L1–L4) and whole body was assessed by d... | PMC10539208 | ||
Results | BMD loss of the 1/3 distal radius | After 2 years, an accelerated BMD loss of the 1/3 distal radius was found with MK-7 supplementation {mean difference of changes relative to placebo −0.023 g/cm | PMC10539208 | |
Conclusion | BMD loss of the 1/3 distal radius | Compared with placebo, an accelerated BMD loss of the 1/3 distal radius was found after 2 years of MK-7 supplementation, whereas a decline in lumbar spine BMD was prevented. As such, MK-7 supplementation might modify BMD site-specifically in patients on dialysis. In aggregate, our findings do not support MK-7 supplemen... | PMC10539208 | |
Graphical Abstract | fracture, chronic kidney disease, BMD loss of the 1/3 distal radius | LOW BONE MINERAL DENSITY, VITAMIN K DEFICIENCY |
In patients with chronic kidney disease on dialysis treatment, low bone mineral density (BMD) is prevalent.Low BMD is associated with an increased risk of bone fracture and mortality.Vitamin K deficiency may contribute to low BMD.
In a 2-year randomised, double-blind, placebo-controlled study of patients on chronic d... | PMC10539208 |
INTRODUCTION | chronic kidney disease, CKD-MBD, bone loss, bone disorder, soft-tissue calcification | BONE LOSS, MINERALIZATION, BONE DISORDER | As kidney function declines, disturbances in the mineral metabolism cause abnormalities in bone turnover, mineralization and bone loss, as well as increased vascular and other soft-tissue calcification, the so-called chronic kidney disease–mineral and bone disorder (CKD-MBD) [BMD may be affected by vitamin K status. In... | PMC10539208 |
MATERIALS AND METHODS | PMC10539208 | |||
Study design | vascular calcification | VASCULAR CALCIFICATION | The RenaKvit trial was a 2-year randomised, multicentre, double-blind, placebo-controlled study examining the effects of vitamin K supplementation as menaquinone-7 (MK-7) on bone and vascular calcification in patients on dialysis treatment. The study design and the effects on vascular calcification have been described ... | PMC10539208 |
Study population and intervention | ADVERSE EVENT | In brief, eligible participants were adult patients on chronic dialysis treatment not treated with vitamin K antagonists, recombinant parathyroid hormones, anti-osteoporotic drugs or vitamin K supplements. Participants were excluded during follow-up if they initiated vitamin K antagonist treatment, were <50% adherent t... | PMC10539208 | |
Outcomes | fractures | The primary outcome was changes in BMD of the 1/3 distal radius, since BMD of the 1/3 distal radius predicts fractures in patients on dialysis treatment [ | PMC10539208 | |
Measurements | PMC10539208 | |||
Dual-energy X-ray absorptiometry (DXA) | BMD of the distal half of the left radius [divided into the 1/3 (most proximal 20 mm), mid and ultradistal radius (most distal 15 mm)], lumbar spine (L1–L4), left femoral neck and whole body were assessed by DXA. DXA procedures are described in detail in Supplementary Material 4S. | PMC10539208 | ||
Biochemical measurements | Serum vitamin K1 and MK-7 were analysed by mass spectrometry according to Boegh | PMC10539208 | ||
Conventional X-ray of the lumbar spine | AAC scores were quantified as per Kauppila | PMC10539208 | ||
Statistical methods | SECONDARY | No data on changes in BMD over time of the 1/3 distal radius were available in patients on dialysis when the study was planned. The sample size calculation was therefore based on cross-sectional data in which a difference in BMD of the 1/3 distal radius of 0.26 g/cmDue to severe heteroscedasticity in the MK-7 group, th... | PMC10539208 | |
RESULTS | ±, fracture, SD | ACUTE MYOCARDIAL INFARCTION | A total of 689 patients on dialysis were screened for eligibility (Fig. CONSORT flow diagram. GI, gastro intestinal; PTH, parathyroid hormone. Baseline characteristics of participants.B: blood; P: plasma; S: serum; FGF-23: fibroblast growth factor 23; BSAP: bone-specific alkaline phosphatase; CTX-1: type I collagen cro... | PMC10539208 |
DXA | DXA scans were performed in 92 of the 97 participants at year 1 and in 62 of the 65 participants completing the study at year 2 (Fig. | PMC10539208 | ||
Distal radius BMD | After 1 year, BMD of the 1/3 distal radius decreased significantly in both the group treated with MK-7 {−0.015 g/cmEffects of 2-years of supplementation with vitamin K2 (MK-7, 360 μg daily) or placebo: Bone mineral density of the distal radius. Mixed effect model analysis of changes in bone mineral density of the dista... | PMC10539208 | ||
Lumbar spine, femoral neck and whole body BMD | After 1 year, BMD of the lumbar spine did not change significantly in either the MK-7 or placebo groups and the mean changes from baseline or absolute BMD levels did not differ between study groups (Effects of 2-years of supplementation with vitamin K2 (MK-7, 360 μg daily) or placebo: Bone mineral density. Mixed effect... | PMC10539208 | ||
Biochemical outcomes | PMC10539208 | |||
Markers of vitamin K | At baseline, participants were highly vitamin K deficient, as demonstrated by the elevated levels of plasma dp-uc-MGP (P-dp-uc-MGP) and PIVKA-II.Serum MK-7 (S-MK-7) increased significantly in the MK-7 group but remained stable in the placebo group. The mean changes from baseline and the absolute MK-7 levels differed hi... | PMC10539208 | ||
Markers of mineral and bone turnover | There were no significant differences between the study groups in the markers of mineral metabolism or bone turnover at any time (all | PMC10539208 | ||
Conventional X-ray of the lumbar spine | fractures, lumbar vertebral compression | After 1 and 2 years, AAC scores increased in both study groups, but the changes from baseline (The number and extent of lumbar vertebral compression fractures did not differ between the study groups at baseline ( | PMC10539208 | |
Clinical outcomes | death, bone fracture | THROMBOEMBOLIC EVENT | The number of participants who experienced bone fracture, parathyroidectomy, a thromboembolic event or death during the study did not differ between study groups (ITT analyses; all | PMC10539208 |
Adherence and AEs | SAEs | The mean adherence to study tablets was >90% after year 1 and 2 in both study groups. A total of 110 participants experienced 968 AEs during the trial and 481 SAEs occurred in 90 participants.The number of participants who experienced an AE or SAE did not differ between groups (all | PMC10539208 | |
DISCUSSION | uraemia, ESKD, BMD loss of the 1/3 distal radius, osteoarthritis, kidney impairment, fractures, arteriovenous fistula | URAEMIA, STILL, OSTEOARTHRITIS, RECRUITMENT, AORTIC CALCIFICATION | In the present randomised, double-blind, placebo-controlled trial, the effects on bone of daily supplementation with 360 µg vitamin K2 (MK-7) were compared with placebo in 123 patients receiving chronic dialysis treatment. In the ITT analysis, an accelerated BMD loss of the 1/3 distal radius was observed with MK-7 supp... | PMC10539208 |
Supplementary Material | Click here for additional data file. | PMC10539208 | ||
ACKNOWLEDGEMENTS | RENAL | The authors wish to express their gratitude to the lab technicians and staff at the Departments of Clinical Biochemistry and Immunology at Lillebælt Hospital, Vejle, and Zealand University Hospital, Denmark, and to the study nurses and lab technicians at the Department of Renal Medicine, Aarhus University Hospital, Dep... | PMC10539208 | |
FUNDING | KIDNEY | The study was funded by the Danish Society of Nephrology, Danish Kidney Association, Region Zealand Research Foundation, Kappa Bioscience AS, Aase and Ejnar Danielsens Foundation, Helen and Ejnar Bjørnows Foundation, Beckett Foundation and Karen Elise Jensens Foundation. Kappa Bioscience AS and Orkla Care AS donated st... | PMC10539208 | |
AUTHORS’ CONTRIBUTIONS | M.F.H. | K.L.-S., D.H., M.F.-M., N.E.F. and P.M. designed the study. K.L.-S., C.D.P., K.D.K., C.S. and J.D.J. collected the clinical data. A.S., C.L.B., J.S.M. and N.R.J. were responsible for the specialized biochemical analyses. M.F.H., B.L. and P.V. conducted the DXA scans. H.S. and J.B.F. led and analysed the radiological in... | PMC10539208 | |
DATA AVAILABILITY STATEMENT | Our data sharing statement is available as Supplementary Table 13S. | PMC10539208 | ||
CONFLICT OF INTEREST STATEMENT | JENSEN | K.L.-S.’s salary was partially funded by Kappa Bioscience AS, the Danish Society of Nephrology and the Karen Elise Jensen Foundation during the RenaKvit trial. M.F.H. has received a research grant from Orkla Care AS. B.L. has received research grants from Amgen and honoraria for academic services from Amgen, UCB, Gilea... | PMC10539208 | |
REFERENCES | PMC10539208 | |||
Background | Urinary incontinence | URINARY INCONTINENCE | Urinary incontinence (UI) is a highly prevalent health concern commonly observed during and after pregnancy that can substantially impact women’s physical and psychological well-being and quality of life. Owing to its numerous advantages, mobile health may be a promising solution; however, it is unclear whether the app... | PMC10337423 |
Objective | URINARY INCONTINENCE | This study aimed to evaluate the effectiveness of the Urinary Incontinence for Women (UIW) app–based intervention for UI symptom improvement among pregnant women in China. | PMC10337423 | |
Methods | incontinence | SECONDARY, INCONTINENCE | Singleton pregnant women without incontinence before pregnancy who were aged ≥18 years and between 24 and 28 weeks of gestation were recruited from a tertiary public hospital in China and were randomly allocated (1:1) to either an experimental group (n=63) or a control group (n=63). The experimental group received the ... | PMC10337423 |
Results | Participants in the experimental and control groups were comparable at baseline. Of the 126 overall participants, 117 (92.9%) and 103 (81.7%) women completed follow-up visits at 2 months after randomization and 6 weeks after delivery, respectively. A statistically significant difference in UI symptom severity was obser... | PMC10337423 | ||
Conclusions | LATE PREGNANCY | The app-based UI self-management intervention (UIW) effectively improved UI symptom severity, quality of life, self-efficacy with PFMT, and knowledge of UI during the late pregnancy and early postnatal periods. Larger multicenter studies with a longer postpartum follow-up are required to further extend these findings. | PMC10337423 | |
Trial Registration | Chinese Clinical Trial Registry ChiCTR1800016171; http://www.chictr.org.cn/showproj.aspx?proj=27455 | PMC10337423 | ||
International Registered Report Identifier (IRRID) | RR2-10.2196/22771 | PMC10337423 | ||
Introduction | chronic illness, Urinary incontinence | URINARY INCONTINENCE, CHRONIC ILLNESS, URINARY INCONTINENCE, LEAKAGE | Urinary incontinence (UI), defined as the involuntary leakage of urine [Pelvic floor muscle training (PFMT) is the first-line conservative treatment for UI [In recent years, an increasing body of research has demonstrated that mobile health (mHealth) interventions may benefit health promotion, especially in chronic ill... | PMC10337423 |
Methods | PMC10337423 | |||
Study Design | This was a single-center, 2-arm, unblinded pragmatic randomized controlled trial with 1:1 intervention allocation that was reported in line with the CONSORT-eHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) guidelines ( | PMC10337423 | ||
Ethics Approval | The study was registered in the Chinese Clinical Trial Registry (ChiCTR1800016171), and the ethical approval was obtained from the Ethics Committees of Shenzhen Hospital, Southern Medical University (NYSZYYEC20190012). The trial protocol has been published, and the findings from an embedded process evaluation will be p... | PMC10337423 | ||
Participants | heart disease, cognitive impairment, pain, psychiatric, pelvic floor muscle contraction, pelvic organ prolapse | PREGNANCY-INDUCED HYPERTENSION, HEART DISEASE, DIABETES MELLITUS, PLACENTA PREVIA, PLACENTAL ABRUPTION, FETAL GROWTH RESTRICTION, THREATENED ABORTION | A trained graduate nurse sequentially recruited participants during routine obstetrics clinic visits at Shenzhen Hospital, Southern Medical University, a tertiary level A public hospital in China, between June and October 2020. Eligibility was first assessed by checking the medical records from the obstetrics clinic, a... | PMC10337423 |
Randomization and Masking | The trial used a simple randomization approach. A 1:1 random assignment sequence was generated via a table of random numbers by a research assistant who was not involved in the study and was placed into sequentially numbered, opaque, and sealed envelopes. When each participant was enrolled, the intervention manager ope... | PMC10337423 | ||
Interventions | PMC10337423 | |||
UIW App | The participants allocated to the experimental group were granted access to the UIW app, which is a mobile app for Chinese pregnant women developed by our research team with technical assistance from the Guangdong Zhuoshang Network Technology Company (registration number: 2019SR1342273). The introduction of the UIW app... | PMC10337423 | ||
Contents of staged pelvic floor muscle training program in the Urinary Incontinence for Women app (test contraction: 2-second contraction and 2-second relaxation; strong contraction: 6-second contraction and 6-second relaxation; and rapid contraction: 3-second contraction and 3-second relaxation). | CONTRACTION, CONTRACTIONS |
Stage 1: eight test contractions for 1 set of exercises, 3 sets per dayStage 2: eight test contractions+2 strong contractions for 1 set of exercises, 3 sets per day
Stage 1: eight strong contractions+1 endurance contraction for 1 set of exercises, 3 sets per day; endurance contraction at this stage was 15-second contr... | PMC10337423 |
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