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3.3.3. Fruit, Vegetables, and Diet Quality
A clinically meaningful increase in the servings of fruit per day was observed in the txt4two cohort, compared with the PC cohort, 0.4 (±0.9) versus 0 (±0.9); however, this did not reach statistical significance (
PMC9921852
3.3.4. Physical Activity
Non-significant increases in total physical activity were observed between groups over time (+45.8 min); the sample was not powered to detect statistical differences. Non-meaningful changes were observed in minutes of sedentary time and percentage of women meeting physical activity guidelines.
PMC9921852
4. Discussion
dietary behaviors
RECRUITMENT
This paper outlines the outcomes and key learnings from a pragmatic implementation of an adapted digital health program into the MMH antenatal service. The outcomes suggest that the program could feasibly be implemented with the considerable time and effort required to adapt and embed the program within the interdepend...
PMC9921852
Strengths and Limitations
The adaptation and testing of an effective and acceptable theoretically underpinned program that had robust formative concept testing and piloting phases was a strength of this study [
PMC9921852
5. Conclusions
Adapting and implementing a previously tested digital intervention into a tertiary maternity hospital was feasible and elicited positive dietary quality and physical activity engagement changes. The barriers to this process included fragmented and unagile hospital and research governance and systems, while the enablers...
PMC9921852
Supplementary Materials
The following supporting information can be downloaded at: Click here for additional data file.
PMC9921852
Author Contributions
Conceptualization, S.A.W. and J.C.W.; methodology, S.A.W., B.F. and J.C.W.; formal analysis, S.A.W.; investigation, S.A.W.; data curation, S.A.W.; writing—original draft preparation, S.A.W.; writing—review and editing, S.A.W., B.F. and J.C.W.; project administration, S.A.W.; funding acquisition, S.A.W. All authors have...
PMC9921852
Institutional Review Board Statement
The study was conducted in accordance with the Declaration of Helsinki and approved by the Mater Misericordiae Ltd. Human Research Ethics Committee (HREC/MML/47416).
PMC9921852
Informed Consent Statement
Informed consent was obtained from all subjects involved in the study.
PMC9921852
Data Availability Statement
The data presented in this study are available on request from the corresponding author. The data are not publicly available, due to privacy issues.
PMC9921852
Conflicts of Interest
The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
PMC9921852
Introduction
Diabetes
VITREOUS HEMORRHAGE, PROLIFERATIVE DIABETIC RETINOPATHY (PDR), DIABETES
Edited by: Sobha Sivaprasad, NHS Foundation Trust, United KingdomReviewed by: Yong Tao, Beijing Chaoyang Hospital, Capital Medical University, China; Xiaodong Sun, Shanghai First People's Hospital, ChinaThis article was submitted to Clinical Diabetes, a section of the journal Frontiers in Public HealthThe aim of this s...
PMC9875129
Methods
PDR
This study involved a prospective, randomized clinical trial. One hundred twenty-eight eyes of 128 patients of PDR who underwent pars plana vitrectomy (PPV) were enrolled. Sixty-four eyes were assigned randomly to either the IVA group (IVA injection 1 to 5 days before PPV) or the control group (no IVA injection). The p...
PMC9875129
Results
The VH incidences in the IVA group and the control group were 14.8 and 39.3% at week 1, 8.6 and 31.7% at month 1, 11.7 and 30.5% at month 2, and 8.6 and 30.5% at month 3, respectively. Intergroup differences showed a significantly decreased VH rate in the IVA group compared with that in the control group at week 1, mon...
PMC9875129
Conclusions
PDR
This study found that the adjunctive use of preoperative IVA reduces early and late postoperative VH in vitrectomy for PDR.
PMC9875129
Introduction
diabetic retinopathy, TRD, PDR, Diabetic retinopathy, tractional retinal detachment, vitreous hemorrhage, vision loss, diabetes
DIABETIC RETINOPATHY, TRACTIONAL RETINAL DETACHMENT, DIABETIC RETINOPATHY, POSTOPERATIVE COMPLICATIONS, RETINA, PROLIFERATIVE DIABETIC RETINOPATHY (PDR), VITREOUS HEMORRHAGE, COMPLICATIONS, DIABETES
Patients with diabetic retinopathy (DR) are becoming more and more predominant in many countries with the increasing prevalence of diabetes worldwide. Diabetic retinopathy is the leading cause of vision loss in patients with diabetes. The standard and effective surgical treatment for vitreous hemorrhage (VH) and tracti...
PMC9875129
Methods
PDR, myocardial infarction, liver or kidney dysfunction, diabetes mellitus, tractional retinal detachment, Diabetic Retinopathy, tamponade, postvitrectomy, choroidal or retinal disease, cerebrovascular accident, IOL, hypertension, T2DM, coagulation mechanism disorder
SYSTEMIC DISEASE, DIABETES MELLITUS, RETINAL TEAR, DIABETIC RETINOPATHY, EVENTS, INTRAOPERATIVE BLEEDING, POSTOPERATIVE COMPLICATIONS, PROLIFERATION, EYE, TRACTIONAL RETINAL DETACHMENT, IOL, LENS, TYPE 2 DIABETES MELLITUS, COMPLICATIONS, INTRAOCULAR PRESSURE, MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT, NEOVASCULAR...
This was a prospective, randomized clinical trial (NCT 05478967). The study followed the tenets of the Declaration of Helsinki and was approved by the Institutional Review Board of the Peking University People's Hospital. Written informed consent was signed by all participants before enrollment.The present study enroll...
PMC9875129
Results
vitreous hemorrhage, TRD, NVG, fifty-four
VITREOUS HEMORRHAGE, NEOVASCULAR GLAUCOMA, ENDOPHTHALMITIS, VITREOUS HEMORRHAGE, RESOLUTION
One hundred fifty-four eyes were enrolled in the study and allocated randomly into two groups: 78 eyes in the IVA group and 76 eyes in the control group. During follow-up, 26 eyes were excluded: 16 cases because of the loss of follow-up and 10 eyes because of the administration of intravitreal silicone oil injection. F...
PMC9875129
Discussion
PDR, TRD, Diabetic retinopathy, blindness, ischemia, tamponade
DIABETIC RETINOPATHY, BLINDNESS, ISCHEMIA, COMPLICATION, BLIND, NEOVASCULARIZATION, SCLERA, REGRESSION
Diabetic retinopathy (DR) is one of the leading causes of being legally blind in working-aged people and is responsible for up to 4.8% of blindness worldwide. Although PPV was the standard management for PDR with VH or TRD, they may suffer from postoperative VH. This complication will hinder fundus monitoring and/or ad...
PMC9875129
Data availability statement
The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.
PMC9875129
Ethics statement
The studies involving human participants were reviewed and approved by Institutional Review Board of People's Hospital of Peking University. The patients/participants provided their written informed consent to participate in this study.
PMC9875129
Author contributions
JQ and XL contributed to the interpretation of the data. The first draft of the manuscript was written by JQ and all authors commented on previous versions of the manuscript. All authors contributed to the study's conception and design. All authors read and approved the final manuscript.
PMC9875129
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.
PMC9875129
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 ...
PMC9875129
References
PMC9875129
Aims
cord injury
KCL‐286 is an orally available agonist that activates the retinoic acid receptor (RAR) β2, a transcription factor which stimulates axonal outgrowth. The investigational medicinal product is being developed for treatment of spinal cord injury (SCI). This adaptive dose escalation study evaluated the tolerability, safety ...
PMC10835503
Methods
BLIND
The design was a double blind, randomized, placebo‐controlled dose escalation study in 2 parts: a single ascending dose adaptive design with a food interaction arm, and a multiple ascending dose design. RARβ2 mRNA expression was evaluated in white blood cells.
PMC10835503
Results
rash
ADVERSE EVENTS, EYE DISORDERS
At the highest single and multiple ascending doses (100 mg), no trends or clinically important differences were noted in the incidence or intensity of adverse events (AEs), serious AEs or other safety assessments with none leading to withdrawal from the study. The AEs were dry skin, rash, skin exfoliation, raised liver...
PMC10835503
Conclusion
KCL‐286 was well tolerated by healthy human participants following doses that exceeded potentially clinically relevant plasma exposures based on preclinical in vivo models. Target engagement shows the drug candidate activates its receptor. These findings support further development of KCL‐286 as a novel oral treatment ...
PMC10835503
What is already known about this subject
injuries
SCAR
Retinoic acid receptor (RAR) β signalling is involved in central nervous system (CNS) regeneration.RARβ is a neuronal transcription factor that regulates numerous pathways in CNS regeneration; these include, axonal outgrowth, synaptogenesis, modulation of the glial scar and axonal pathfinding.KCL‐286 is a preclinical ...
PMC10835503
What this study adds
nerve injuries, cord injury
KCL‐286 was tested in healthy male adults to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of this agent under investigation for the treatment of spinal cord injury.Safety and pharmacokinetic data indicate that KCL‐286 is well tolerated at a 100‐mg daily dose, which equates to a dose shown ...
PMC10835503
INTRODUCTION
RA, cord injury, road accidents
The reported global prevalence of spinal cord injury (SCI) is between 0.7 and 1.2 million incident cases per year with falls and road accidents being the major causes.The retinoic acid (RA) signalling pathway has been shown to be involved in axonal outgrowth. The pathway consists of the nuclear receptors, the RA recept...
PMC10835503
MATERIAL AND METHODS
PMC10835503
Study oversight
PD, SAD
BLIND
The present study is a phase 1, first‐in‐human double blind, randomized, placebo‐controlled trial, in male healthy volunteers, consisting of a single ascending dose (SAD) adaptive design with a food interaction (FI) arm, and a multiple ascending dose (MAD) design, to evaluate the safety, tolerability, PK and pharmacody...
PMC10835503
Study design
SAD
SECONDARY, BLIND
This was a prospective, Phase I, double blind, randomized, placebo controlled, dose escalating study conducted at 2 sites. The study comprised 2 parts: Part A included SAD in 8 cohorts (S1 to S8) with a food interaction (FI) arm of 1 cohort and Part B MAD in 5 cohorts (M1 to M5) in which the volunteers were dosed once ...
PMC10835503
Study participants
Healthy adult males aged between 19 and 45 years were randomized into the trial. Female volunteers were excluded from this study as at that time reproductive toxicology data were not complete in female models. Participants had a body mass index ≥18 and ≤30 kg/m
PMC10835503
Sample collection and analysis
BLOOD
Blood and urine samples for PK analysis were collected from the individuals in all groups within 2 h before dosing and at 0.5, 1 1.25, 1.5, 2, 3, 5, 8, 12, 24, 36 and 48 h after dosing. Venous blood samples were collected in heparin treated tubes, and centrifuged within 30 min (400 × g, 4°C, 10 min). The upper plasma l...
PMC10835503
PK assessments
PMC10835503
Determination of drug concentrations and dose proportionality
Plasma and urine PK parameters of KCL‐286 were analysed using noncompartmental analysis. Actual dosing and PK sampling times were used for PK parameters. Linear log trapezoidal method (linear on ascending and log on descending concentrations) was used to integrate the plasma concentration time profiles out to the time ...
PMC10835503
Starting dose and escalation decisions
Safety results and limitations imposed by the protocol were the primary consideration when deciding on the starting dose and subsequent dose for the next cohort. To calculate the starting dose, the no‐observed‐adverse‐effect level from Day‐28 dog toxicokinetic study was used for planned ceiling exposure and dose level....
PMC10835503
Statistical methods
The data processing and statistical analysis of the results were performed by Richmond Pharmacology Limited. The PK parameters were computed using WinNonlin™ PK software (version 6.3 or higher Pharsight Corp, Sunnyvale, CA, USA). All other analyses were conducted using SAS PC Version 9.4 or later (SAS Institute, NC, US...
PMC10835503
Nomenclature of targets and ligands
Key protein targets and ligands in this article are hyperlinked to corresponding entries in
PMC10835503
RESULTS
PMC10835503
Subjects
SAD
A total of 109 healthy male participants took part in the study. The SAD substudy comprised 56 randomized participants: 42 participants across the single dose KCL‐286 treatment arms and 14 participants in the placebo arm. Across the cohorts, participants randomized to KCL‐286 included 3 to 1 mg, 4 to 2 mg, 5 to 48 mg a...
PMC10835503
SAD
SAD
Plasma concentration–time profiles overlaid for each dose group in the SAD (linear) are in Figure Overlaid mean plasma KCL‐286 concentration Summary of pharmacokinetic parameters at Day 1 (PK set)—single ascending dose.Abbreviations: Ae, KCL‐286 excreted unchanged in a collection period; AeData show mean and standard d...
PMC10835503
MAD
Plasma concentration–time profiles overlaid for each dose group of the MAD cohorts are in Figure Overlaid mean plasma KCL‐286 concentration Summary of pharmacokinetic parameters (PK set)—multiple ascending dose.Abbreviations: Ae, KCL‐286 excreted unchanged in a collection period; AeData show mean and standard deviation...
PMC10835503
Food effect
Plasma concentration–time profiles and plasma PK parameters following single oral doses of 6 mg KCL‐286 in fasted and fed participants are shown in Figure Summary of overall pharmacokinetic parameters (PK set)—food interaction.Abbreviations: Ae, KCL‐286 excreted unchanged in a collection period; AeData show mean and st...
PMC10835503
Assessment of dose proportionality
PMC10835503
SAD (includes 6‐mg dose from the food interaction substudy)
Increase in mean plasma exposure was between proportional and subproportional with dose in terms of mean CFor the 6‐mg fasted dose from the FI substudy, dose‐proportionality exposure increase was within 2‐fold of the nominal dose increment, and was considered to be effectively dose proportional and within normal variab...
PMC10835503
MAD
For the MAD cohorts, across the entire dose range steady‐state concentration was achieved from Day 3 or earlier at predose. Low concentrations of KCL‐286 were detected around 1 ng/mL from 36 or 48 h postdose through to the follow‐up time (nominally 168 h after dose 7). Over the entire dose range investigated there was ...
PMC10835503
Urine: All parts of the study
The amount of drug secreted in urine was proportional to the dose administered throughout all participants of the study (Tables 
PMC10835503
PD results
PMC10835503
Exploratory biomarker for target engagement
RARβ2 was not detected in WBCs isolated from plasma from placebo samples or the 1‐ and 12‐mg dosed MAD cohorts. In the MAD cohorts of 24, 75 and 100 mg dosing, RARβ2 expression upon ligand binding becomes upregulated and measurable (Figure Expression of retinoic acid receptor (RAR)β2 in white blood cells in multiple as...
PMC10835503
Safety evaluation
dry skin, epistaxis, stomatitis, abnormal dreams, TEAEs, pain, dizziness, nasal congestion, headache, paraesthesia, dysgeusia, TEAE, SAD
STOMATITIS, MEDICAL DEVICE SITE IRRITATION, EVENT, HYPERBILIRUBINAEMIA, DRY EYE, OCULAR HYPERAEMIA, PARAESTHESIA, EPISTAXIS, EVENTS, INJECTION SITE BRUISING, HYPERTRIGLYCERIDAEMIA
An overview of treatment‐emergent AEs (TEAEs) is provided for SAD in Table Across the SAD substudy, 56 TEAEs were reported by 31/56 (55.4%) participants. No dose relationship for any TEAE was evident. The most common TEAEs reported in the KCL‐286 treated participants included abnormal dreams (3 participants), skin exfo...
PMC10835503
DISCUSSION
nerve injuries, dry irritated, axonal regenerationThe TEAEs, SAD
MINOR
The treatment of nerve injuries including SCI is a major unmet clinical need as there are no therapies that can lead to axonal regeneration and functional recovery. RARβ2 activation is an attractive target to treat an SCI, as it is a neuronal located transcription factor that has multiple effects on pathways involved i...
PMC10835503
CONCLUSIONS
PD, injuries, SCIs
This study has demonstrated that KCL‐286 an orally available RARβ agonist, engages its receptor, and the safety, tolerability, PK and PD data support the use of up to 100 mg daily in fed conditions for future clinical studies in SCIs and other CNS injuries where axonal regeneration is required.
PMC10835503
AUTHOR CONTRIBUTIONS
P.
Jonathan P. T. Corcoran, Maria B. Goncalves, Adrian P. Mander, Tim Mant, Jane Holmes, Daryl Bendel, Jörg Täubel, John Posner, Henry Fok and Hana Hassanin made substantial contributions to the conception and design of the work and the analysis and interpretation of the data as well as drafting and revising the work. E.C...
PMC10835503
CONFLICT OF INTEREST STATEMENT
The authors declare no competing financial interests. MBG and J.P.T.C have a matter of composition patent for KCL‐286.
PMC10835503
Supporting information
Click here for additional data file.
PMC10835503
ACKNOWLEDGMENTS
We thank the NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London, for their support.
PMC10835503
DATA AVAILABILITY STATEMENT
The data in this article belong to the sponsor. The data may be made available to readers with permission from the corresponding author and sponsor.
PMC10835503
REFERENCES
PMC10835503
Background
hepatitis B
HEPATITIS B, VIRUS, CHRONIC HEPATITIS, HEPATITIS D
The geographical distribution of hepatitis B virus (HBV) and hepatitis D virus (HDV) genotypes is uneven and has its own clinical and organizational implications for health systems. Despite the introduction of vaccination and successful antiviral therapy the prevalence of chronic hepatitis B (with or without delta agen...
PMC10426108
Methods
CHRONIC HEPATITIS
Total 834 chronic hepatitis B (with or without delta agent) patients were included to the study from November 2017 to June 2019. The material was collected from the regional hepatological сenters from 13 cities of Kazakhstan. Genotyping of HBV/HDV isolates was carried out using phylogenetic analysis of null-binary sequ...
PMC10426108
Results
Overall 341 samples were PCR-positive and genotyped for HBV. Comparison and phylogenetic analysis of nucleotide sequences of HBV isolates showed that they were represented by genotypes HBV-D (95.9%), HBV-A (3.5%) and HBV-C (0.6%). At the same time, the identity of the nucleotide sequences of Kazakhstani isolates were: ...
PMC10426108
Conclusion
CHRONIC HEPATITIS
This study describes for the first time the molecular epidemiology of HBV and HDV in Kazakhstan. The data obtained expand the knowledge of the global epidemiology of viruses; have potential implications for public health policy and for further clinical research on chronic hepatitis in Kazakhstan.
PMC10426108
Trial registration
ClinicalTrials.gov NCT05095181 (registered on 27/10/2021).
PMC10426108
Supplementary Information
The online version contains supplementary material available at 10.1186/s12879-023-08524-1.
PMC10426108
Keywords
PMC10426108
Introduction
hepatitis B infection, cirrhosis, Cirrhosis, HBV infection
CIRRHOSIS, INFECTION, HEPATITIS B INFECTION, CIRRHOSIS, SUPERINFECTION, DISEASES
The burden of hepatitis B infection is highest in the WHO Western Pacific Region and the WHO African Region, where 116 million and 81 million people, respectively, are chronically infected. Sixty million people are infected in the WHO Eastern Mediterranean Region, 18 million in the WHO South-East Asia Region, 14 millio...
PMC10426108
Materials and methods
PMC10426108
Study population
chronic hepatitis B
The study involved 834 adults with chronic hepatitis B (the presence of HBsAg in the blood or serum for more than 6 months), who were treated in regional hepatological centers during the November 2017 to June 2019 in 13 cities of Kazakhstan.
PMC10426108
Ethics statement
Study was approved by the institutional review board of Local Ethical Committee of the National Scientific Center of Surgery named after A.N. Syzganov (Almaty, Kazakhstan) on 14 September 2017. Informed written consent was obtained after detailed explanation of the study at the time of sampling from all participants.
PMC10426108
Serological analysis
HbsAg (Abbott ARCHITECT
PMC10426108
DNA isolation
-20
Venous blood from HBV and HDV positive patients were used for studies. HBV DNA and HDV RNA were isolated using the GeneJET Viral DNA/RNA Purification Kit (Thermo Fisher Scientific™, USA) according to the manufacturer’s instructions. 200 µl of venous blood with EDTA was used for isolation. cDNA from RNA was obtained usi...
PMC10426108
PCR for DNA amplification
SEPARATION, AMPLIFICATION, POSITIVE
PCR was performed using a set of specific primers proposed by Sitnik et al. (2004) for HBV and Shahinsaz et al. (Shahinsaz et al., 2006) for HDV, the characteristics of which presented in Tables S1 and S2 [In the absence of a PCR product of a given size, a second round of PCR was performed with nested primers and under...
PMC10426108
Sequencing of PCR products and nucleotide sequence analysis of HBV and HDV
SEPARATION
Before sequencing, PCR products of HBV/HDV were purified from primer and nucleotide residues using ExoSAP-IT™ PCR Product Cleanup Reagent (Applied Biosystems™, USA) according to the manufacturer’s instructions. The purified PCR products were sequenced in two directions, using a forward and reverse FHBS1-RHBS1 or FHBS2-...
PMC10426108
Genotyping and HBV/HDV reference sequences
Verification of HBV DNA and HDV RNA sequences was carried out using the Nucleotide BLAST application as well as using the Genotyping (HBV) application [Genotyping of HBV/HDV isolates was carried out using phylogenetic analysis of null-binary sequences of Kazakhstani isolates, in comparison with the reference sequences ...
PMC10426108
Results
Among 834 patients registered in hepatological centers of the Republic of Kazakhstan, 487 samples were positive for HBsAg at the time of the study, among which 341 were PCR-positive for HBV and genotyped. Among 487 HBsAg-positive samples, 261 samples were also positive for HDAg, while 256 were PCR-positive for HDV and ...
PMC10426108
Hepatitis B virus genotyping results
hepatitis B, ’ blood
HEPATITIS B, VIRUS
Patients’ blood (487 samples in total) positive for HBsAg were obtained from the following regions of the Republic of Kazakhstan: Aktau, Atyrau, Oskemen, Turkestan, Taraz, Chimkent, Almaty, Astana, Kyzylorda, Pavlodar, Aktobe, Kostanay and Karaganda.In total, out of 487 samples, 341 samples were positive for PCR and ge...
PMC10426108
The result of a study of hepatitis D virus genotypes
VIRUS
Patient blood (261 samples) positive for HBsAg and anti-HDVAg ELISA were received from the following regions: Taraz, Chimkent, Almaty and Almaty region, Kyzyl-Orda, Pavlodar, Aktobe, Oskemen, Aktau, Atyrau, South Kazakhstan region.In total, out of 261 samples, 256 samples (98%) were PCR positive and genotyped. Comparis...
PMC10426108
Discussion
HDV
This study described for the first time the molecular (genetic) epidemiology of hepatitis B and hepatitis Delta viruses in Kazakhstan. A total sample of 341 people with HBV and 256 people with HDV were genotyped.The most common HBV genotype was the D genotype (95.9%), specifically subgenotype D1 (61.5%) in Kazakhstan. ...
PMC10426108
Conclusion
Current study was the first to describe the molecular epidemiology of HBV and HDV in Kazakhstan. The genotype D (namely, the D1 subgenotype) of the HBV was predominant, and in all cases, the genotype 1 of the HDV was identified. The data obtained expand the knowledge of the global epidemiology of HBV and HDV and have c...
PMC10426108
Acknowledgements
The authors thank the administration of the regional hepatological centers of Kazakhstan for their support in conducting the study.
PMC10426108
Author contributions
Conceptualization and Methodology: B.I.; Investigation and Data curation: B.A., K.Sh., G.A., and G.I.; Genetic testing: V.B., M.S., D.M., J.G., and I.S.; Formal analysis: D.S.; Writing - original draft preparation: B.I., B.A., and B.B.; Writing - review and editing: B.I. and A.B.; Funding acquisition: B.I.; Supervision...
PMC10426108
Funding
This research was funded by the Ministry of Healthcare of the Republic of Kazakhstan, grant number OR12165486 “National Programme for the Introduction of Personalized and Preventive Medicine in The Republic of Kazakhstan (2021–2023)” (Grant number OR12165486, registration number 0119РКИ0356).
PMC10426108
Data Availability
All data available by request to corresponding author.
PMC10426108
Declarations
PMC10426108
Ethics approval and consent to participate
This study is being carried out in accordance with relevant guidelines and regulations. All participants had given written informed consent to one of the study investigators in accordance with the Declaration of Helsinki. Study was approved by the institutional review board of Local Ethical Committee of the National Sc...
PMC10426108
Consent for publication
Not applicable.
PMC10426108
Clinical trial registration
ClinicalTrials.gov NCT05095181 (registered on 27/10/2021).
PMC10426108
Competing interests
The authors declare that they have no competing interests.
PMC10426108
List of abbreviations
hepatitis B, Hepatitis B virusHepatitis D
HEPATITIS B
Hepatitis B virusHepatitis D virusWorld Health OrganizationChronic hepatitis B
PMC10426108
References
PMC10426108
Objectives
SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
To explore the feasibility and effectiveness of telehealth-supervised exercise for adults with Systemic lupus erythematosus (SLE).
PMC9944478
Methods
fatigue, pain
This was a non-randomised controlled pilot trial comparing telehealth-supervised exercise (8 weeks, 2 days/week, 45 min, moderate intensity) plus usual care with usual care alone. Mixed methods were used to assess change in fatigue (FACIT-fatigue), quality of life (SF36), resting fatigue and pain (11-point scale), lowe...
PMC9944478
Results
Fifteen female adults with SLE were included (control group
PMC9944478
Conclusion
Key findings from this mixed-method investigation suggest that telehealth-supervised exercise was feasible for, and well-accepted by, adults with SLE and resulted in some modest health improvements. We recommend a follow-up RCT with more SLE participants.
PMC9944478
Introduction
chronic, multisystem, autoimmune disease
CARDIOPULMONARY DISEASES, AUTOIMMUNE DISEASE, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Systemic lupus erythematosus (SLE) is a chronic, multisystem, autoimmune disease characterised by an immune response to self-antigens.Telehealth is a possible strategy for delivering exercise interventions for people with SLE that may alleviate some of the reported barriers (i.e. exercise performed in the comfort of th...
PMC9944478
Methods
PMC9944478