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References
PMC9831378
Background:
SECONDARY
Fathers are important in establishing healthy behaviors in their children, but are rarely engaged in lifestyle programs. Focusing on physical activity (PA) of both fathers and their children by engaging them together in PA (i.e. “co-PA”) is therefore a promising novel strategy for interventions. The study aim was to in...
PMC9930712
Methods:
SECONDARY
This study is a non-randomized controlled trial (nRCT), including 98 fathers and one of their 6 to 8 years old children (intervention = 35, control = 63). The intervention was implemented over a 14-week period, and consisted of six (inter)active father-child sessions and an online component. Due to COVID-19, only 2/6 s...
PMC9930712
Results:
Significant intervention effects were found for co-PA (+ 24 min./day in the intervention compared to the control group, p = 0.002), and MPA of the father (+ 17 min./day, p = 0.035). For children, a significant increase in LPA (+ 35 min./day, p < 0.001) was found. However, an inverse intervention effect was found for th...
PMC9930712
Conclusion:
The Run Daddy Run intervention was able to improve co-PA, MPA of fathers and LPA of children, and decreasing their SB. Inverse intervention effects were however found for MPA and VPA of children. These results are unique given their magnitude and clinical relevance. Targeting fathers together with their children might ...
PMC9930712
Trial registration number:
This study is registered as a clinical trial (clinicaltrials.gov, ID number: NCT04590755, date: 19/10/2020).
PMC9930712
Keywords:
PMC9930712
Background
Physical inactivity is a global pandemic and a leading cause of physical and mental health issues [Lifestyle interventions targeting children’s health behaviours, including PA, have often included parents as an important focus of change, as parents play a critical role in the health behaviours of their children [It is ...
PMC9930712
Methods
PMC9930712
Study design
The design of the Run Daddy Run study was a non-randomized controlled trial (nRCT), with a two-group pretest-posttest control group. In this design, participants were recruited in sequence (see Fig. Measurements were performed immediately before the intervention (baseline) and immediately after the 14-week intervention...
PMC9930712
The Run Daddy Run intervention
PMC9930712
Development of the intervention
The Behaviour Change Wheel was used as a theoretical framework to systematically develop the intervention [
PMC9930712
Content of the intervention
FMS
FMS
The aim of the intervention was to improve father-child co-PA, and consequently the objectively measured PA levels of both. Secondary aims of the intervention were to target (co-) sedentary behaviour (SB), body mass index (BMI), family health climate regarding PA and the quality of father-child relationship. The Behavi...
PMC9930712
The intervention and restrictions during COVID-19
MAY
During the baseline measurements (November-January 2019–2020), no COVID-19 restrictions were applicable. During the post-test measurements (in June 2020), “mild” COVID-19 restrictions were applicable, meaning that (1) catering industry (e.g. restaurants, bars, cafés) and (non-essential) shops were open, (2) school were...
PMC9930712
Sample size
The required sample size to evaluate the effect of the intervention was calculated, using the software GPower 3.0.10 [
PMC9930712
Participants and recruitment
RECRUITMENT
The Run Daddy Run intervention targeted fathers and (one of) their children of the first three years of primary school (i.e. 6–8 years old). For more information on recruitment, see [Father-child dyads were recruited through convenience and snowball sampling, in November 2019-January 2020 (see also [
PMC9930712
Co-physical activity
Co-PA includes all types of PA that involves “active play”, and is jointly performed by the father and the child (e.g. playing soccer together, rough-and-tumble play, cycling). Co-PA was measured using a 7-day recall diary, investigating all physical activities fathers and children performed together in the last seven ...
PMC9930712
Physical activity and sedentary Behaviour
PMC9930712
Data collection
Device-based
Device-based measures of PA and SB data were collected using wrist-worn accelerometers (Axivity AX3, 3-axial) (continuous wave-form data, sampling frequency 100-Hz). Compared to hip-worn accelerometers, wrist-worn accelerometers have better wear time adherence and acceptability [
PMC9930712
Data processing
Minus
Based on the accelerometer data, participants’ total volume of PA (mean Euclidean Norm Minus One (ENMO, in m
PMC9930712
Secondary outcomes: body mass index, PA family health climate and quality of the father-child relationship
Fathers’ Body Mass Index (BMI, in kg/m²) was calculated based on self-reported height and weight through the online questionnaire. BMI z-scores (i.e. a sex- and age adjusted measure of BMI) of children were also calculated based on their weight and height, which were proxy-reported by the father in the questionnaire. T...
PMC9930712
Results
PMC9930712
Descriptive statistics
In total, data of 98 father-child dyads were analyzed at baseline (mean age fathers/male caregivers: 43.79 ± 5.92 years, mean age primary school aged children: 8.19 ± 0.99 years; 50.90% boys). The flow diagram of participants throughout the study can be found in Fig. 
PMC9930712
Primary outcomes
PMC9930712
Co-physical activity
Results for the self-reported co-PA outcomes are shown in Table 
PMC9930712
Physical activity
For PA of the father, relative to the control group, the intervention group significantly improved from pre- to post-test for total volume of PA (+ 6.1 m
PMC9930712
Secondary outcomes: sedentary behaviour, body mass index, PA family health climate and quality of the father-child relationship
SECONDARY
Results for the secondary outcomes are shown in Table 
PMC9930712
Discussion
SECONDARY
This study evaluated the effects of a theory-based, co-created intervention aiming to improve co-physical activity (i.e. the father and the child being active together), which was used as a strategy to increase PA in both children and fathers. The ‘Run Daddy Run’ intervention led to an increase in self-reported father-...
PMC9930712
Acknowledgements
Not applicable.
PMC9930712
Author contributions
JL and GC designed the project. RB conducted the accelerometer data processing. JL conducted the data analysis, under the supervision of RB. PJM provided additional input for the study design. JL wrote the original draft. GC, PJM, RB and SC edited the manuscript and provided feedback. All authors read and approved the ...
PMC9930712
Funding
The research of authors Julie Latomme and Ruben Brondeel is funded by Research Foundation Flanders. The funding body is not involved in the study design, collection, management, analysis and interpretation of data or in writing of the report.
PMC9930712
Data Availability
The datasets used and analyzed during the current study, and the full trial protocol, are available from the corresponding author on reasonable request.
PMC9930712
Ethics approval and consent to participate
This study was approved by the Committee of Medical Ethics of the Ghent University Hospital (Belgian registration number: B670201941599) and registered as a clinical trial on 19/10/2020 (Clinicaltrials.gov NCT04590755). Participants of this study received an information letter in which they were informed on the study, ...
PMC9930712
Consent for publication
Not applicable.
PMC9930712
Competing interests
The authors declare that they have no competing interests.
PMC9930712
Abbreviations
Minus
Physical activity.Light physical activity.Moderate physical activity.Vigorous physical activity.Moderate-to-vigorous physical activity.Sedentary behaviour.milli-gravitational unit.Euclidean Norm Minus One.Co-physical activity.Fundamental Movement Skills.
PMC9930712
References
PMC9930712
Introduction
cancer
CANCER
Open access funding provided by SCELC, Statewide California Electronic Library ConsortiumSince the beginning of the COVID-19 pandemic, the use of remote telemonitoring and telehealth platforms has been of steadily increasing interest, and implementation continues to rise [One population that has been identified as pote...
PMC10694107
Materials and methods
PMC10694107
Patients
gastrointestinal oncologic surgery
Patients undergoing gastrointestinal oncologic surgery (all colorectal surgery, pancreatectomy, hepatectomy and gastrectomy) at a single institution over 18 years of age who could read and write in English were eligible for inclusion. All eligible patients were screened. Only those patients who had completed all partic...
PMC10694107
Randomization and procedures
A study algorithm detailing randomization, subsequent allocation, and follow-up is shown in the CONSORT diagram in Fig. CONSORT diagramSatisfaction tool
PMC10694107
Outcomes
The primary outcome was feasibility as defined by the percent of patients completing electronic surveys at 70% of all time points. Acceptability was assessed by a patient satisfaction tool assessing ease of use, time burden of participation, and technological access after completion of the 30-day tracking period (Fig. 
PMC10694107
Statistical analysis
Univariate analysis was performed using SPSS version 28.0 (Armonk, New York). Patient characteristics including demographics and surgical treatment were compared between groups using Student’s t-test for continuous variables, the Pearson Chi-square test for categorical variables, and the Mann–Whitney U test for ordinal...
PMC10694107
Results
One hundred and six patients were screened, of which 83 (78.3%) consented to participate and 65 (78.3%) completed participation by August 31, 2022 (Fig. Patient demographicsPerioperative characteristicsLaparoscopic orMIS/robotic assisted Overall, 88% (57 patients) completed 70% of the time points. Patients in the inter...
PMC10694107
Discussion
PGHD, gastrointestinal oncologic operations
COMPLICATIONS
This study is one of the first to incorporate PGHD in the form of vital signs, mobility, and ePROs, coupled with nursing intervention triggered by set thresholds [However, there are many questions to be answered regarding the applicability and utility of such an approach in the perioperative care of such patients. The ...
PMC10694107
Funding
Open access funding provided by SCELC, Statewide California Electronic Library Consortium. This study was funded by NIH grant, sponsor ID NR019866-01.
PMC10694107
Declarations
PMC10694107
Conflict of interest
The authors declare they have no conflict of interest to disclose.
PMC10694107
Ethical approval
Informed consent was obtained from all individual patients included in the study. This study was approved by the institutional review board and was performed in accordance with the ethical standards as laid down by the Declaration of Helsinki.
PMC10694107
References
PMC10694107
Abstract
PMC10013951
Introduction
knee arthroplasty, TKA, pain
We aimed to evaluate the efficacy of electroacupuncture in relieving acute pain after total knee arthroplasty (TKA) and related mechanism.
PMC10013951
Methods
electroacupuncture, postoperative acute pain, sham‐acupuncture
In this randomized, single‐blind, and sham‐acupuncture controlled study. Forty patients with postoperative acute pain were recruited and randomly divided electroacupuncture group (
PMC10013951
Results
calcarine fissure, acute pain, TKA
CORTEX
Compared with the HCs, patients with acute pain following TKA had significantly decreased ALFF value in right middle frontal gyrus, right supplementary motor area, bilateral precuneus, right calcarine fissure and surrounding cortex, and left triangular part of inferior frontal gyrus (false discovery rate corrected
PMC10013951
Conclusions
acute pain, pain
The functional activities of related brain regions decreased in patients with acute pain after TKA. The enhancement of the functional activity of precuneus may be the neurobiological mechanism of electroacupuncture in treating pain following TKA. Bingxin Kang, Chi Zhao, and Jie Ma contributed equally.
PMC10013951
INTRODUCTION
postoperative pain, human diseases, acute postoperative pain, acute pain, Tu, knee osteoarthritis, pain, knee arthroplasty, KOA, TKA, migraine
DISORDERS, CHRONIC PAIN, MIGRAINE, KNEE OSTEOARTHRITIS
Total knee arthroplasty (TKA) can effectively treat end‐stage knee osteoarthritis (KOA) by reducing pain and helping patients to resume daily life activities. Acute postoperative pain after TKA prolongs rehabilitation duration, weakens the therapeutic effect, and thereby decreases the patient's quality of life. Intense...
PMC10013951
MATERIALS AND METHODS
PMC10013951
Standard protocol approvals, registration, and consents
The study took place at Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine from November 1, 2020 to October 31, 2021. The study protocol was preregistered with ClinicalTrials.gov (No.ChiCRT2000033778, June 14, 2020,
PMC10013951
Study participants
loss of consciousness, neurological and psychiatric disorders, pain, KOA, claustrophobia, head trauma, NRS
HYPERPYREXIA, ORGANIC DISEASE, DISEASES
Enrolled were KOA patients having undergone primary unilateral TKA. The inclusion criteria included (1) aged 60–80 years; (2) right‐handed; (3) a pain intensity score of 5 or higher on a 0–10 Numerical Rating Scale (NRS); (4) a score > 24 on the Minimum Mental State Examination. The excluded criteria included (1) a his...
PMC10013951
Experimental design and sample size
postoperative pain, NRS, sham‐acupuncture, pain
A participant‐blinded, randomized and sham‐acupuncture (SA) controlled clinical trial was applied. Previous studies have shown that 15 participants should be included in each group to ensure stable statistical effect for brain fMRI analysis (Qiu et al., The study lasted for 5 days: from postoperative day (POD) 3 to POD...
PMC10013951
Masking and intervention
The group allocation information was sealed an envelope and given to the acupuncturist. The surgeons, principal investigators, study staff, data analysts, and the participants were blinded to grouping. Using the sham electroacupuncture design in the previous literature(Liu et al., In SA group, noninserted sham needles ...
PMC10013951
Clinical assessment
depression, Depression, NRS, pain
SECONDARY
Nonsteroidal anti‐inflammatory drug was used for analgesia, and supplementary dosage could be administered if needed. No additional analgesic medication was asked for in both EA and SA groups throughout the study. All patients underwent rs‐fMRI scan twice. The demographic information and clinical scale data (dependent ...
PMC10013951
Rs‐fMRI data acquisition
The rs‐fMRI data were acquired using a Clinical 1.5 Tesla whole body MR imager (United Imaging, Shanghai, China). Although our previous clinical trial (Kang et al.,
PMC10013951
Data processing and analyzing
PMC10013951
Statistical analysis
Clinical outcomes were analyzed using a statistical package for windows version 25 (SPSS, IBM Inc., Chicago, IL). A single‐factor ANOVA/two‐sample
PMC10013951
ALFF analysis
The data was processed by the Data Processing Assistant for rs‐fMRI (Restplus) based on Statistical Parametric Mapping 12 (SPM 12, The blood oxygen level‐dependent time series for each voxel was converted to the frequency domain with fast Fourier transform. The square root of the power spectrum was computed and average...
PMC10013951
Correlation analysis
The EA‐stimulation difference (EA_ POD 7 vs. POD 3) and group difference (HCs vs. patients at POD 3) were chosen as the regions of interest (ROI). The mean values in the ROI between the two groups were analyzed using the receiver operating characteristic curves. Pearson's correlation coefficients were calculated to ind...
PMC10013951
RESULTS
PMC10013951
Baseline characteristics
Totally, 38 patients (20 in EA group, 18 in SA group) completed the two rs‐fMRI scans (baseline and after 5‐day treatment). Forty HCs completed one rs‐fMRI scan. Due to excessive head movement (>3 mm) in scan, 7 patients and 8 HCs were excluded (Figure Folw chart of screening, randomization and intervention. SA, sham‐a...
PMC10013951
Clinical outcomes
Depression
Table Clinical outcome measurements in the EA and SA groupsEA, electroacupuncture; SA, sham‐acupuncture; NRS, numerical rating scale; SDS, Self‐Rating Depression Scale.
PMC10013951
ALFF analysis
calcarine fissure
CORTEX
Compared with HCs, all patients at POD 3 had significantly lower ALFF in the right middle frontal gyrus (MFG), right supplementary motor area (SMA), bilateral precuneus, right calcarine fissure and surrounding cortex (CAL), and left triangular part of inferior frontal gyrus (IFGtriang) (Table Comparisons of ALFF values...
PMC10013951
Correlation between ALFF and pain intensity after intervention
Depression, NRS
The EA‐stimulation difference (EA_ POD 7 vs. POD 3) and group difference (HCs vs. patients at POD 3) as shown by ALFF overlapped in bilateral precuneus, which was chosen as the ROI. Correlation analysis revealed that the change (POD 7–POD 3) in ALFF of bilateral precuneus were negatively correlated with the change of N...
PMC10013951
Complications and adverse events
liver or kidney injury, infection, hematoma, skin ulcer
ADVERSE EVENTS, INFECTION, HEMATOMA, SKIN ULCER
All incisions were healed by the first intention. No skin ulcer, hematoma, infection, liver or kidney injury, or other adverse events was observed.
PMC10013951
DISCUSSION
head movements, pain, TKA, depression, Morton et, EA reduced
CORTEX
The transmission of pain in the central nervous system is highly complicated and involves multiple brain regions (Kim et al., We found that patients had lower ALFF in right MFG, right SMA, bilateral precuneus, right CAL, and left IFGtriang following TKA (preintervention), compared with HCs without any pain symptoms. MF...
PMC10013951
CONCLUSION
acute pain, TKA, pain
In conclusion, the functional activities in the right MFG, right SMA, bilateral precuneus, right CAL, and left IFGtriang in patients with acute pain after TKA decreased. EA on four acupoints (Futu, Zusanli, Yinglingquan, and Yanglingquan) can increase the functional activities of right cuneus, right angular gyrus, MOG,...
PMC10013951
AUTHOR CONTRIBUTIONS
LBX
BXK, CZ, and JM conceived the study; BXK drafted the study; HQW, XLG, HX, SZ, CXG, and XRX recruited the participants. XYA and JX collected clinical data. MMD and CZ were responsible for statistical analyses and tables. LBX and JS have primary responsibility for the final content. All authors contributed to writing and...
PMC10013951
CONFLICT OF INTEREST STATEMENT
The authors declare that they have no conflict of interest.
PMC10013951
ETHICS STATEMENT
This study was approved by the Ethics Committee of Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine and was in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent to participate was obtained from all of the ind...
PMC10013951
TRIAL REGISTRATION
The trial was registered in Chinese Clinical Trial Registry (ChiCTR2000033778).
PMC10013951
PEER REVIEW
The peer review history for this article is available at
PMC10013951
ACKNOWLEDGMENTS
We are grateful to the participants who volunteered to participate in this research.
PMC10013951
DATA AVAILABILITY STATEMENT
The data sets used and analyzed during the current study are available from the corresponding author on reasonable request.
PMC10013951
REFERENCES
PMC10013951
Background
Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor.
PMC10147789
Aim
To determine the equally potent dose of ciprofol compared with propofol as an induction agent for general anesthesia in patients undergoing selective surgery, and to assess its safety.
PMC10147789
Method
ADVERSE EVENTS, SECONDARY
A total of 109 patients undergoing selective non-emergency, non-cardiothoracic or non-neurosurgical surgery requiring tracheal intubation for general anesthesia were enrolled. Ten patients per group were assigned to ciprofol-0.3, 0.4 and 0.5 mg/kg, and propofol-2.0 or 2.5 mg/kg groups, respectively to receive an intrav...
PMC10147789
Results
The success rates were 100% for all 5 groups. The mean time to MOAA/S ≤ 1 and the time to loss of the eyelash reflex were not different among the 5 groups, regardless of whether a top-up dose was needed. There were no significant differences in the incidences and severity of AEs in the dose ranges investigated of cipro...
PMC10147789
Conclusion
The efficacy and safety of a single bolus dose of ciprofol-0.5 mg/kg for the general anesthesia induction in selective surgery patients was comparable to that of propofol-2.0 mg/kg.
PMC10147789
Trial registration
Clinicaltrials.gov, NCT03698617, retrospectively registered.
PMC10147789
Supplementary Information
The online version contains supplementary material available at 10.1007/s11096-022-01529-x.
PMC10147789
Keywords
PMC10147789
Impact statements
Propofol is commonly used for procedural sedation, but since it has the disadvantage of a narrow therapeutic index, alternative sedation drugs with improved drug dosing properties are desirable.Ciprofol is a novel drug for procedural sedation and general anesthesia with a potency about 4–5 times higher than propofol, ...
PMC10147789
Introduction
Propofol is commonly used for procedural sedation [Ciprofol emulsion (HSK3486), a 2, 6-disubstituted phenol derivative [We assumed that ciprofol would have a similar success rate to propofol for the induction of general anesthesia and here we also provide guidance for its the clinical applications.
PMC10147789
Aim
Based on previous phase 2 results, in this phase 2 study, we aimed to: (1) determine the equally potent dose of ciprofol compared with propofol as an induction agent for general anesthesia in patients undergoing selective surgery; and (2) to assess its safety.
PMC10147789
Ethics approval
WEST
The study was approved by the Institutional Review Board (IRB) of Peking University First Hospital (Approval No. 2016-46; December 28th, 2016), West China Hospital, Sichuan University (Approval No. 2017-32; January 15th, 2018) and all other participating medical centers. Prior written informed consent was obtained from...
PMC10147789
Method
PMC10147789
Study design and patients
This was a phase 2a, 7-center, open-labeled, non-randomized and positive controlled clinical trial. The study consisted of two parts: part 1, dose escalation and part 2, dose expansion. The trial was registered at clinicaltrials.gov (NCT03698617).The inclusion criteria for participants were: 18–65 years old; non-pregna...
PMC10147789
Part I: Dose escalation
In a previous phase 1 study, the results indicated that ciprofol 0.4 mg/kg, administered as a single i.v. bolus dose, was suitable for inducing general anesthesia in healthy adults. Therefore, in this phase 2a study, we chose 3 doses of ciprofol (0.3, 0.4, 0.5 mg/kg) and 2 doses of propofol (2.0, 2.5 mg/kg). The plan w...
PMC10147789
For top-up doses and numbers selection
The sedation level was assessed using the Modified Observer’s Assessment of Alertness/Sedation scores (MOAA/S) [
PMC10147789
Part II: Dose expansion
Upon completion of the part I study, a part 2 study was performed. Based on the results of the 5 groups (n = 10 for each group the study started with), an additional 20 patients were planned to be enrolled in each of the ciprofol-0.3, 0.5 mg/kg and propofol-2.0 mg/kg groups, respectively.
PMC10147789