title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Consent for publication | Not applicable. | PMC10338470 | ||
References | PMC10338470 | |||
Abstract | PMC10435932 | |||
Introduction | cough | BRONCHIECTASIS, SIDE EFFECT, ADVERSE EVENTS, BRONCHIAL HYPERREACTIVITY, BRONCHOSPASM | Tobramycin inhalation solution (TIS) is a treatment option for patients with frequent exacerbations of bronchiectasis. A possible side effect of TIS is the development of chronic cough and bronchospasm, whereby the guidelines suggest a (in hospital) tolerance test with the first dose of TIS. However, data on respiratory adverse events are not consistent. In the present analysis from the BATTLE study (NCT02657473), we evaluated the added value of the tolerance test and aimed to observe the development of inhaled treatment related bronchial hyperreactivity. | PMC10435932 |
Methods | Fifty‐seven | ADVERSE EVENT | Fifty‐seven patients from the BATTLE study were analyzed. Patients were randomized to receive TIS or placebo OD for 1 year. A tolerance test was performed with spirometry measurements before and after the first dose and with a bronchodilator in advance. Adverse events were strictly monitored. | PMC10435932 |
Results | Fifty‐seven, airway hyperresponsiveness | AIRWAY HYPERRESPONSIVENESS | Fifty‐seven patients (100%) passed the tolerance test with no decrease in spirometry measurements or development of local intolerability. During the study treatment, a total of five TIS‐treated patients (17.8%) withdrew due to airway hyperresponsiveness after a mean of 9.2 (SD13.9) weeks and one placebo‐treated patient (3.5%) after 2 weeks (TIS vs. placebo; | PMC10435932 |
Conclusion | heterogenous bronchiectasis, airway hyperresponsiveness | AIRWAY HYPERRESPONSIVENESS, ADVERSE EFFECTS | The use of inhaled medication is well tolerated in the heterogenous bronchiectasis population, without signs of airway hyperresponsiveness after the first dose of inhaled medication. From this observation, it can be concluded that there is no additional value for this advised tolerance test. However, closely monitoring on adverse effects during the first weeks after starting TIS is recommended.In this sub‐analysis from the BATTLE RCT, the use of inhaled medication (TIS or NaCl 0.9%) was evaluated whereby no signs of airway hyperresponsiveness were observed after the first dose. It can be concluded that there is no additional value for this advised tolerance test. However, during study treatment, airway hyperresponsiveness was seen after a mean of 9.2 (SD 13.9) weeks, whereby closely monitoring on adverse/site effects during the first weeks of TIS is recommended.
| PMC10435932 |
INTRODUCTION | CHRONIC INFLAMMATION, BRONCHIECTASIS | Bronchiectasis is characterized by the presence of dilated bronchi and chronic inflammation, which leads to persistent coughing and sputum production with recurrent exacerbations. | PMC10435932 | |
METHODS | PMC10435932 | |||
Study population | In the present analysis, data from the BATTLE RCT were included. | PMC10435932 | ||
Objectives | bronchiectasis, airway hyperresponsiveness | ADVERSE EVENTS, AIRWAY HYPERRESPONSIVENESS, BRONCHIECTASIS | The primary objective of this study is to evaluate the presence of airway hyperresponsiveness during the tolerance test in patients treated with TIS as compared with placebo. Secondary objectives were time to first signs of airway hyperresponsiveness for patients treated with TIS as compared with placebo, number of treatment‐related adverse events, and etiology of bronchiectasis patients in whom intolerability of the inhaled medication occurs. | PMC10435932 |
Tolerance test | Patients were clinically stable at the start of the study, and a tolerance test with the first dose of the study medication was performed for each patient at the outpatient ward. Patients were excluded if they failed the tolerance test. Study visits were planned every 3 months for 1 year, and a diary card was used every week to obtain information on the development of possible side effects (Figure All patients underwent this supervised test dose by using the InnoSpire Deluxe at the outpatient ward at visit 0 (the start of the study) to assess the occurrence of local intolerability. Patients continued their own maintenance inhaled medication during the tolerance test and next to the study medication.A spirometry measurement was performed 20 min before the first dose of the study medication. All patients received a short‐acting beta agonist (200 mcg salbutamol dose aerosol with aerochamber) 5 min before the study medication. Spirometry measurements were repeated 20 min after the use of the inhaled study medication (Figure | PMC10435932 | ||
Statistical analysis | Statistical analysis was conducted using IBM SPSS 25 for Windows. Discrete variables were presented as counts (percentage) and continuous variables as mean with ±standard deviation (SD) if normally distributed or median with interquartile range (IQR) if not normally distributed. Comparison between groups was performed using the independent samples test if normally distributed and the Mann–Whitney U test if not normally distributed. For comparison between groups with multiple variables, a chi‐square test was used. Within each treatment group, changes in FEV1 and FVC pre and post study medication were analyzed using the Wilcoxon signed rank test. A | PMC10435932 | ||
RESULTS | PMC10435932 | |||
Patients | Fifty‐seven | Fifty‐seven patients out of 58 who participated in the BATTLE studyPatient characteristics.
Abbreviations: AZM, azithromycin; ICS, inhalation corticosteroids; IQR, interquartile range; LABA, long acting β agonist; LAMA, long‐acting anticholinergics; SABA, short acting β agonist; SAMA, short acting anticholinergics; SD, standard deviation. | PMC10435932 | |
Tolerance test | airway obstruction, SD | AIRWAY OBSTRUCTION | The tolerance test was performed in 57 patients, whereof 2 (3.5%) patients did not receive salbutamol dose aerosol in advance. All patients passed the tolerance test without severe airway obstruction (defined as a decrease in FEVTolerance test.
Abbreviations: FEV1, forced expiratory volume in one second; FVC, forced vital capacity; SD, standard deviation.A total of 16 patients (28%) were known to have FEV1% of predicted <50% before the use of the inhaled study medication, of which 11 patients (68.8%) were treated with TIS. For this subpopulation with a FEV1 <50% of predicted, a significant improvement was found in the FEV1% of predicted from 39.1% (SD 7.4) to 41.5% (SD 8.9) during the tolerance test ( | PMC10435932 |
Reasons for study discontinuation | renal impairment, bronchiectasis, allergic reaction, swelling, idiopathic bronchiectasis, tinnitus, ototoxicity, COPD | RENAL IMPAIRMENT, BRONCHIECTASIS, ALLERGIC REACTION, ADVERSE EVENTS, TINNITUS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, IDIOPATHIC BRONCHIECTASIS, ASTHMA, OTOTOXICITY | During the study treatment, a total of 18 (31.6%) patients withdrew from the study: 11 (19.3%) TIS‐treated patients after a mean of 10 weeks (SD 10.6) and 7 (12%) placebo‐treated patients after a mean of 7.7 (SD 6.4) weeks (Overview of reasons for study discontinuation.
Abbreviations: ns, non‐significant; SD, standard deviation.Of these six patients who stopped the study, one TIS‐treated patient (16.7%) was an actual smoker, whereas the other patients never smoked. For one TIS‐treated patient, the etiology of bronchiectasis was defined as asthma; two patients were known to have idiopathic bronchiectasis, one post‐infective, and one with immunodeficiency‐related bronchiectasis. The placebo‐treated patient was known to have asthma‐related bronchiectasis. None of them was known to have chronic obstructive pulmonary disease (COPD) (Table Regarding specific adverse events based on the aminoglycoside safety profile in the patients who have been withdrawn, no TIS‐treated patients experienced ototoxicity; one patient (9%) showed reversible renal impairment after a treatment period of 9 months; and one patient (9%) showed an allergic reaction with swelling and irritation of the lips after the use of TIS, which was not seen during the tolerance test. One (9%) placebo‐treated patient experienced ototoxicity with tinnitus during the treatment period. For this patient, an audiogram was performed, which showed no signs of medication related ototoxicity. An overview of all the adverse events and serious adverse events in the total population is shown in Table | PMC10435932 |
DISCUSSION | renal impairment, bronchiectasis, dyspnea, heterogenous bronchiectasis, cough, airway hyperresponsiveness | RENAL IMPAIRMENT, BRONCHIECTASIS, ADVERSE EVENTS, AIRWAY OBSTRUCTION, AIRWAY HYPERRESPONSIVENESS, ADVERSE EFFECTS | The present sub‐analysis of the BATTLE studyA total of 57 patients underwent a tolerance test with the first dose of the inhaled medication (TIS or placebo) with salbutamol DA in advance. None of these patients showed a lung function decline or other signs of airway hyperresponsiveness after the tolerance test. Despite a normal tolerance test, airway hyperresponsiveness developed especially during the first weeks of maintenance treatment, whereby in our study, six (10.5%) out of the 57 patients showed airway obstruction, dyspnea, or chronic cough. None of the other adverse effects of TIS during the study could be predicted by the tolerance test.Based on this observation, no additional value was seen for this advised tolerance test; however, closely monitoring in the first weeks after the start of maintenance inhalation treatment seems more relevant.Higher percentages, up to 30%, in the occurrence of airway hyperresponsiveness were described in previous studies with TIS; however, bronchodilation in advance was not standard used in these studies.Only in a few studies in bronchiectasis was a tolerance test or supervised test dose performed before the use of an inhaled treatment option.Maintenance use with inhaled antibiotics is time‐consuming and takes about 20–30 min a day, and it includes the preparation of the device, the use of the inhaled medication, and the cleaning protocol afterwards. This time‐consuming therapy has been a reason for a total of seven patients (38.9%) to be withdrawn from our study. They experienced an insufficient effect of the treatment in combination with a too intensive study schedule. Other adverse events obtained in our study were (reversible) renal impairment after the use of TIS, which was at comparable rates to those described in the recently published iBEST studyIn our study, bronchiectasis patients with pre‐existing low spirometry measurements were included (FEV1 < 50% of predicted), and even in this population, the use of the inhaled study medication was well tolerated. Only one patient dropped out of the study after a period of 3 weeks due to airway hyperresponsiveness despite the use of a bronchodilator.In conclusion, the use of inhaled medication (TIS or NaCl 0.9%) is well tolerated in the heterogenous bronchiectasis population without signs of airway hyperresponsiveness after the first dose of inhaled medication. From this observation, it can be concluded that there is no additional value for this advised tolerance test. However, closely monitoring adverse/site effects during the first weeks of TIS is recommended. | PMC10435932 |
AUTHOR CONTRIBUTIONS | W. G. Boersma and Lotte C. Terpstra designed and drafted the manuscript. All authors were involved in revising the manuscript and have given final approval of the version to be published. | PMC10435932 | ||
CONFLICT OF INTEREST STATEMENT | WGB reported grants paid to his institution from GlaxoSmithKline and reported consulting fee for the Adviesraad 2021. IB and HH reported grants form Longfonds and CF fonds paid to their institution. LCT and DG have nothing to disclose. | PMC10435932 | ||
ETHICS STATEMENT | This study is a sub analysis of the BATTLE study. The BATTLE study protocol was reviewed and approved by independent ethics committees and institutional review boards from all the six participating centres. The study was performed in accordance with the Good Clinical Practice guidelines, the International Conference on Harmonization guidelines and the most recent version of the Declaration of Helsinki. Written informed consent for participation and publication of our results was obtained from all the participants at the screenings visit. The BATTLE study is registered on Clinical trials.gov number: NCT02 657473. | PMC10435932 | ||
Supporting information |
Click here for additional data file. | PMC10435932 | ||
ACKNOWLEDGEMENTS | Not applicable. | PMC10435932 | ||
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions. | PMC10435932 | ||
REFERENCES | PMC10435932 | |||
1. Introduction | obesity, depression, anxiety, diabetes | OBESITY, PREGNANCY-INDUCED HYPERTENSION, SECONDARY, COMPLICATIONS, DIABETES | Mental health problems and obesity are two common complications during pregnancy and postpartum. The preconception period is considered an appropriate period for prevention. Therefore, insights into interpregnancy mental health and the impact on weight and body composition are of interest to developing effective weight management strategies. The primary aim of this study is to assess the difference in women’s mental health during the interpregnancy period and the association with pre-pregnancy body mass index (BMI) and body composition. The secondary aim is to study whether this association is affected by socio-demographic factors, interpregnancy interval and sleep. The study is a secondary analysis of the INTER-ACT e-health-supported lifestyle trial. Women were eligible if they had a subsequent pregnancy and mental health measurements at 6 weeks after childbirth and at the start of the next pregnancy (In high-income countries, it is estimated that 1 in 10 mothers experience perinatal mental health problems [Negative maternal mental health is associated with women’s weight, body composition and sleep. Women with excessive GWG reported higher levels of maternal anxiety 2 days after childbirth compared to women with adequate GWG [Prenatal lifestyle interventions focusing on diet and physical activity showed a positive impact on reducing GWG; however, the effect on the reduction in perinatal complications (e.g., diabetes and pregnancy-induced hypertension) is limited [The interpregnancy period, which starts after childbirth and ends at the start of the next pregnancy, is an opportune time to address maternal mental health problems, as a history of depression and anxiety is a significant risk factor for postpartum depression [To the best of our knowledge, no studies have investigated the changes in mental health during the interpregnancy period in women with excessive GWG. Insight into the changes in interpregnancy mental health and the impact on weight and body composition can assist in the development of effective and timely weight management strategies in women at risk. The primary aim of this study is to assess the difference in mental health between 6 weeks after childbirth and the start of the next pregnancy and investigate its association with pre-pregnancy weight and body composition. The secondary aim is to study whether this association is affected by socio-demographic factors, interpregnancy interval and sleep. | PMC10384439 |
2. Materials and Methods | weight gain, eating behavior, weight retention, gestational diabetes | PREGNANCY-INDUCED HYPERTENSION, GESTATIONAL DIABETES, COMPLICATIONS | The interpregnancy coaching for a healthy future (INTER-ACT) (ClinicalTrials.gov; NCT02989142) intervention is a combined e-health-supported and face-to-face coaching program, from childbirth to the end of the next pregnancy, in women with excessive gestational weight gain in the previous pregnancy. The primary aim of the study was to assess the effectiveness of the INTER-ACT intervention on pregnancy and birth-related complications (a composite outcome: gestational diabetes, pregnancy-induced hypertension, cesarean section and large-gestational-age babies) in the subsequent pregnancy. Secondary outcomes (postpartum maternal mental health, postpartum weight retention and body composition and postpartum lifestyle behaviors such as eating behavior and physical activity) have already been analyzed [ | PMC10384439 |
2.1. Study Design | The INTER-ACT RCT was a multicenter RCT with a longitudinal study design. Participants received the first study visit 6 weeks after childbirth. The intervention group received the next study visit on week 12 and months 6, 12, 18, 24 and 30 after childbirth and the control group at months 6, 12, 18, 24 and 30. Once participants were pregnant, the visits on previous dates were discontinued and replaced with a pregnancy visit in the first, second and third trimesters. The intervention group received 4 e-health-supported face-to-face coaching sessions during the first 6 months after childbirth in addition to usual care (weeks 6, 8 and 12 and month 6). The control group received usual care only.To address the current research question, we focused on the group of women who started a subsequent pregnancy and who completed mental health questionnaires at 6 weeks after childbirth and at the start of the next pregnancy.The study was conducted according to the guidelines of the Declaration of Helsinki and was approved on 9 March 2017 by the Clinical Trial Centre/Ethical Committee UZ Leuven (protocol code B322201730956/S59889). All participants confirmed their participation by written informed consent. | PMC10384439 | ||
2.2. Participants | MAY | Participants were enrolled in 6 Flemish hospitals between May 2017 and April 2019. Women were informed and recruited by trained study nurses 2 to 3 days after childbirth if they had excessive GWG according to the 2009 National Academy of Medicine (NAM) guideline [A total of 1450 women were enrolled and registered in the electronic case report form (eCRF) system ‘Castor’ ( | PMC10384439 | |
2.3. Measurements | Anxiety, anxiety, depressive symptoms, depression, Depression | All participants were assessed at 6 weeks after childbirth and at the start of the next pregnancy by completing self-reported questionnaires. A personal link to the questionnaire was sent from the eCRF two weeks before the scheduled study visit.Mental health was assessed by using the Edinburgh Postnatal Depression Scale (EPDS) and the Gotland Male Depression Scale (GMDS) for symptoms of depression, the Spielberger State Trait Anxiety Inventory 6-item (sSTAI-6) and the Edinburgh Depression Scale-3 Anxiety item (EDS-3A) for symptoms of anxiety, the Sense Of Coherence-13item (SOC-13) for measuring the sense of coherence and a Linear Analogue Scale (LAS) for measuring quality of life (QoL). Characteristics and cut-off scores of the mental health questionnaires are presented in The EPDS is suitable for assessing symptoms of depression and anxiety during the postpartum period [The GMDS complemented the EPDS as it is a valid instrument for assessing non-typical suicidality-related symptoms of depression. The use of the GMDS as a supplement on the GMDS can increase the detection rate of depressive symptoms [Previous research indicates that three questions from the EPDS questionnaire are also sensitive to the measurement of anxiety [The SOC is measured with the 13-item short scale (SOC-13), derived from the original 29-item Orientation to Life Questionnaire [QoL was assessed using the Linear Analogue Scale (LAS). Participants were asked to score QoL on a scale from 0 to 100, with 0 representing a poor quality of life and 100 an extremely good quality of life. The LAS was one comprehensive score, summarizing physical, psychological and social aspects.Age, level of education, ethnicity, employment status, family composition, family income, a history of depression and a history of anxiety were self-reported at baseline. Questions on breastfeeding and maternal sleep were based on previous research and self-reported at each time point [Interpregnancy mental health was calculated based on 2 measurement points: 6 weeks after childbirth (start interpregnancy) and at the start of the next pregnancy (end of interpregnancy, defined as the timepoint nearest to the start of the next pregnancy and at least within 1 year preconception).The difference in mental health during the interpregnancy period was calculated as the difference between mental health at 6 weeks after childbirth vs. at the start of the next pregnancy for continuous variables and as a change of group according to the cut-off score (high/low) at 6 weeks after childbirth vs. the start of the next pregnancy for categorical variables.Interpregnancy interval was determined by calculating the difference in months between the start date of the next pregnancy (day of childbirth minus gestational age) minus the date of the previous childbirth. | PMC10384439 | |
2.4. Outcomes | Study nurses collected the self-reported pre-pregnancy weight before the previous pregnancy from the medical records 2 to 3 days after childbirth, and the self-reported pre-pregnancy weight of the next pregnancy was questioned by the INTER-ACT coach at the first INTER-ACT pregnancy visit. Body composition was electronically measured by using a Tanita MC 780 SMA bio-electric impedance (BIA) device (Tanita Corporation, Tokyo, Japan) with three frequencies (5, 50 and 250 KHz). BIA is a non-invasive, reliable and safe clinical approach, which is well accepted by patients [Waist circumference was assessed (rounded to 0.1 cm) by using a Seca 201 tape (Seca, Hamburg, Germany) and defined as the midway between the lowest rib and the hip bone [BMI was calculated as weight (kg)/height × height (mThe body measurements took place in the home of the participant, in hospital or elsewhere according to the preference of the participant. | PMC10384439 | ||
2.5. Data Analyses | USA).The, depression, weight retention, anxiety | REGRESSION | Statistical analyses were performed by using Statistical Package for the Social Science (SPSS) version 27.0 (IBM, Armonk, New York, NY, USA) and Statistical Analysis System (SAS) version 9.4 (Cary, New York, NY, USA).The Kolmogorov–Smirnov test in addition to plots and histograms was used to assess the normality of distribution of continuous variables. All mental health variables showed a skewed distribution and were therefore analyzed by using non-parametric tests.Descriptive characteristics were presented as mean and standard deviation or median and interquartile range for continuous variables and frequencies and percentages for categorical variables. To assess differences in participant characteristics between two groups, the unpaired To assess the difference in mental health at 2 different time points in the same patients, the Mc-Nemar test was used for categorical variables and the Wilcoxon signed ranked test for continuous variables.Participants were divided into low/high according to the pre-defined cut-off (We performed regression analyses to assess whether mental health at the start and end of the interpregnancy interval were independent factors associated with BMI and body composition at the start of the next pregnancy. The outcome variables were postpartum weight retention, change in BMI at the start of each pregnancy and body composition at the start of the second pregnancy (BMI, fat percentage, waist circumference and visceral fat). We considered the mental health variables as categorical variables: high/low at the start, high/low at the end and the four possible combinations (high at start and end, high at start but low at end, etc.). We took into account as explanatory variables the following: pre-pregnancy BMI at the start of the previous pregnancy (continuous variable), level of education, exclusive breastfeeding at 6 months, interpregnancy interval (short (≤18 months) vs. normal (18–59 months)), sleep, history of depression, history of anxiety and mental health variables). Stepwise variable selection was performed to assess whether the mental health variables showed independent statistical significance to the outcome variables (BMI and body composition at the start of the next pregnancy). | PMC10384439 |
3. Results | PMC10384439 | |||
3.1. Participant Characteristics | Of the 1450 women randomized in the INTER-ACT trial, 276 women had a next pregnancy and complete data (At baseline (6 weeks after childbirth), a difference in QoL was found between the intervention and control group (median score; 80 versus 81, | PMC10384439 | ||
3.2. Differences in Mental Health between 6 Weeks after Childbirth and Start of Next Pregnancy | anxiety, depressive symptoms | The rate of women with symptoms of anxiety (sSTAI-6 ≥ 40) increased by 13% between 6 weeks after childbirth and the start of the next pregnancy (36% vs. 49%, Also, the rate of women who reported depressive symptoms at the start of the next pregnancy doubled compared to 6 weeks after childbirth (GMDS ≥ 13; 17% versus 8% respectively, Of the women who experienced depressive symptoms (GMDS ≥ 13) at 6 weeks after childbirth (No statistically significant changes were shown for differences in EDS-3A, EPDS, SOC or QoL between 6 weeks after childbirth and the end of the next pregnancy ( | PMC10384439 | |
3.3. Mental-Health-Related Characteristics | PMC10384439 | |||
3.3.1. Socio-Demographic Factors and Interpregnancy Interval | obesity, depressive feelings, anxiety, depressive symptoms | OBESITY | Women with a history of depressive feelings or a history of anxiety feelings reported more often depressive symptoms (EPDS ≥ 10, GMDS ≥ 13), anxiety (sSTAI-6 ≥ 40, EDS-3A ≥ 5) or a low SOC (SOC-13 ≤ 70) at the start of the next pregnancy. Also, women with obesity before the start of the previous pregnancy reported more common depressive symptoms (EPDS ≥ 10, GMDS ≥ 13) and anxiety (sSTAI-6 ≥ 40, EDS-3A ≥ 5) at the start of the next pregnancy compared to healthy weight or overweight women. Details are presented in There was no further statistically significant association between mental health at the start of the next pregnancy (sSTAI-6, EDS-3A, EPDS, GMDS, SOC, QoL or the interpregnancy differences in anxiety (STAI-6; group 1–4)) and parity, level of education, employment status, ethnicity, method of delivery and family composition (There was no association between the length of the interpregnancy interval and maternal mental health at 6 weeks after childbirth or at the start of the next pregnancy. | PMC10384439 |
3.3.2. Sleep | Women with less than 6 h of sleep per night at the start of the next pregnancy more often reported a low SOC (SOC < 70; 5 h or less = 54%; 5–6 h = 59%) compared to women with more than 6 h of sleep per night (SOC < 70; 6–7 h = 35% and more than 7 h = 45%) ( | PMC10384439 | ||
3.4. Association with Pre-Pregnancy BMI and Body Composition | REGRESSION | Regression analyses showed that when taking into account pre-pregnancy BMI of the previous pregnancy, level of education and breastfeeding, only sense of coherence at the start of the next pregnancy was independently associated with women’s BMI and fat percentage at the start of the next pregnancy and BMI change between two pregnancies ( | PMC10384439 | |
4. Discussion | depression, overweight or obesity, anxiety, depressive symptoms | We showed a significant increase in anxiety (+13%, In contrast to the STAI-6 (symptoms of anxiety), sense of coherence is a personality trait that indicates the ability to understand, manage and give meaning to situations. It increases resistance to stress and promotes the person’s development [We also found that symptoms of anxiety and low SOC at the start of the next pregnancy were significantly more common in women with less than 6 h of sleep per night. However, studies investigating sleep during the preconception period and its impact on mother and child outcomes are rather scarce [A remarkably high prevalence (49%) of women who experienced higher levels of anxiety (sSTAI-6 ≥ 40) at the start of the next pregnancy was shown. Most importantly, two-thirds of these women had already high levels of anxiety at 6 weeks after childbirth (i.e., during the postpartum period of the previous pregnancy), without improvement at the next pregnancy. Similarly, one-third of women who were not anxious at 6 weeks after childbirth evolved to experience levels of anxiety at the start of the next pregnancy. A possible reason for the high prevalence of levels of anxiety and depression could be the fact that we only included women with excessive GWG in a previous pregnancy, of which more than 50% were women with overweight/obesity. From recent systematic reviews, it is shown that a high maternal BMI is associated with higher levels of anxiety and depression [Women who dropped out of the study were more likely to be living with overweight or obesity before the previous pregnancy and reported worse mental health scores at 6 weeks after childbirth (A statistically significant increase in levels of depression during the interpregnancy period was shown using the GMDS questionnaire. However, this finding was not supported by the EPDS questionnaire, which is a validated and reliable scale to measure depressive symptoms in women after childbirth [The strength of our study was the use of data from a large longitudinal prospective randomized controlled trial. Furthermore, we analyzed four different mental health outcomes. Including SOC and QoL in addition to depression and anxiety provided new insights and added value to the knowledge of the overall concept of mental health [Our study also has some limitations. Firstly, our study included only women with previous excessive GWG, which is, in general, prevalent in 40–50% of women [ | PMC10384439 | |
5. Conclusions | depressive, anxiety, weight reduction | STRESSFUL EVENTS | Our data show a significant increase in anxiety and depressive symptoms between the start and the end of the interpregnancy period. Of the women who were not anxious at the start, 39% experienced anxiety at the end of interpregnancy. Sense of coherence at the start of the next pregnancy was independently associated with women’s pre-pregnancy BMI and fat percentage. Our results indicate that the interpregnancy period appears to offer an opportunity to develop innovative preventative interventions. We believe that the development of preconception lifestyle interventions that focus on both weight reduction and support in understanding, managing and giving meaning to stressful events (sense of coherence) may be of added value to optimize women’s preconception health. | PMC10384439 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10384439 | ||
Author Contributions | Conceptualization, H.V.U., A.B., L.A. and R.D.; methodology, H.V.U., A.B., L.A. and R.D.; software, L.A.; validation, H.V.U., A.B., L.A. and R.D.; formal analysis, H.V.U. and L.A.; investigation, H.V.U. and L.A.; resources, A.B. and R.D.; data curation, L.A.; writing—original draft preparation, H.V.U.; writing—review and editing, L.A., A.B., R.D., Y.J., C.V.H. and A.S.; visualization, H.V.U. and A.B.; supervision, A.B.; project administration, L.A., A.B. and R.D.; funding acquisition, A.B. and R.D. All authors have read and agreed to the published version of the manuscript. | PMC10384439 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved on 9 March 2017 by the Institutional Review Board (or Ethics Committee) of UZ Leuven (protocol code B322201730956/S59889). | PMC10384439 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10384439 | ||
Data Availability Statement | The study protocol is publicly available. Data requests may be submitted to the Principal Investigator accompanied by a proposal with a planned objective for use of data. | PMC10384439 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10384439 | ||
References | Depression, Anxiety, anxiety, depressive symptoms | REGRESSION, SECONDARY | Flow chart of participant follow-up.Differences in sSTAI-6 and GMDS during the interpregnancy period. sSTAI-6 N = 276; GMDS N = 131; Symptoms of anxiety = sSTAI-6 ≥ 40; depressive symptoms = GMDS ≥ 13; and GMDS was recoded from 3 to 2 categories (<13 and ≥13) because of only 1 case in category 3. group 1 = No symptoms of anxiety at 6 weeks after childbirth and no symptoms of anxiety at the start of next pregnancy; group 2 = Symptoms of anxiety at 6 weeks after childbirth and still symptoms of anxiety at the start of next pregnancy; group 3 = No symptoms of anxiety at 6 weeks after childbirth but symptoms of anxiety at the start of next pregnancy; and group 4 = Symptoms of anxiety at 6 weeks after childbirth but no symptoms of anxiety at the start of next pregnancy.Association between sleep duration and SOC/anxiety at the start of next pregnancy. sSTAI-6 = Spielberger State-Trait Anxiety Inventory 6-item. Significance level was calculated using the Pearson Chi-Square test.Characteristics of the mental health questionnaires.EPDS = Edinburgh Postnatal Depression Scale; GMDS = Gotland Male Depression Scale; sSTAI-6 = spielberger; State-Trait Anxiety Inventory- 6 item; EDS-3A = Edinburgh Depression Scale-3 Anxiety subscale; SOC = Sense Of Coherence; QoL = Quality of Life; Association between mental health (SOC, sSTAI-6, EDS-3A, EPDS, GMDS and QoL) and pre-pregnancy BMI and body composition (regression models after stepwise variable selection).Pre-pregnancy BMI at the start of previous pregnancy (continuous variable), level of education (1 = secondary school, 2 = bachelor/master), exclusive breastfeeding at 6 months (1 = yes, 2 = no), interpregnancy interval (1 = short vs. 2 = normal) and Sense of coherence at the start of next pregnancy (continuous variable). * = Outcome variable. | PMC10384439 |
Purpose | Communicated by Westerterp/Westerblad.The acute physiological, perceptual and neuromuscular responses to volume-matched running and cycling high intensity interval training (HIIT) were studied in team sport athletes. | PMC9813096 | ||
Methods | In a randomized cross-over design, 11 male team sport players completed 3 × 6 min (with 5 min between sets) repeated efforts of 15 s exercising at 120% speed (s | PMC9813096 | ||
Results | Absolute mean | PMC9813096 | ||
Conclusion | Cycling HIIT in team sport athletes is unlikely to meet the requirements for improving run-specific metabolic adaptation but might offer a greater lower limb neuromuscular load. | PMC9813096 | ||
Keywords | PMC9813096 | |||
Introduction | As an appropriate stimulus for improving In many team sports, practitioners and rehabilitation staff will choose training practices that simultaneously reduce musculoskeletal load while promoting appropriate central and peripheral stimuli. The use of cycle-based HIIT has been used with team sport athletes over periods of 2–6 weeks to improve intermittent running and cycling performance (Jones et al. Running and cycling at the same relative intensity evoke distinct physiological and perceptual responses that suggest different stimuli could be applied when adopted by the same athlete (Carter et al. | PMC9813096 | ||
Methods | stature | With Department of Sport and Exercise Sciences ethics approval, 11 male university standard team sport players (age 20.0 ± 0.8 y, stature 181 ± 5 cm, body mass 82.3 ± 12.4 kg) participated in this study after providing written informed consent. Participants represented a range of team sports, including soccer, rugby and basketball. An a priori sample size calculation using G*Power 3.1.9.6 (Faul et al. Participants completed two HIIT trials using either running (H/P Cosmos, Pulsar, Nussdorf-Traunstein, Germany) or cycling (Lode Excalibur Sport, Lode Medical Technology, Groningen, The Netherlands) in a randomized cross-over design, with 5–7 days between trials (temperature: 20.6 ± 0.8 cf. 20.4 ± 0.7 ℃, | PMC9813096 | |
Statistical analysis | All comparisons are reported as effect sizes (Cohen’s d; mean difference between trials/pooled standard deviation) and 95% confidence intervals (ES [95% CI]), with threshold values of 0.0–0.2, trivial; 0.21–0.6, small; 0.61–1.2, moderate; 1.21–2.0, large; > 2.0, very large. These arbitrary thresholds were used in the absence of accepted minimum thresholds for changes in the measurements of interest. Effects with confidence intervals that crossed a small positive or negative change were classified as unclear. For those wishing to interpret the analysis using a more traditional approach, we provide | PMC9813096 | ||
Results | breathlessness | sPhysiological responses to maximal running and cycling tests. Data are mean ± SD*denotes different to cycling value (Physiological responses to running and cycling HIIT sessions are shown in Table Physiological responses to running and cycling HIIT sessions*denotes different to cycling value (Time spent > 90%There were large differences in mean HR with running higher than cycling for absolute (ES [95% CI] = 1.53 [0.53–2.41], There were small differences in dRPE-O (69.8 ± 18.7 cf. 60.5 ± 14.7; ES [95% CI] = 0.55 [− 0.32–1.38], Differential rating of perceived exertion (dRPE) for overall exertion (dRPE-O; closed circle), leg-muscle exertion (dRPE-L; closed square) and breathlessness (dRPE-B; closed triangle) during running and cycling HIIT sessions. Values are mean (bars; overall = grey, leg = white, breathlessness = diagonal) and individual responses. *denotes difference between exercise modes (There was a trivial reduction in MVC (600.9 ± 105.6 to 597.0 ± 107.6 N; ∆% − 0.5 ± 5.8%) after running HIIT (ES [95% CI] = − 0.04 [− 0.80–0.8], MVC before and after running and cycling-based HIIT sessions. Values are mean (bars; running = grey, cycling = white) and lines are individual responses. *Indicates different to before value ( | PMC9813096 | |
Discussion | breathlessness, fatigue | Running elicited a higher Given the greater capacity and requirement for oxygen consumption during running, absolute mean Time spent at > 90% While understanding the The higher reported breathlessness (dRPE-B) for running probably reflected the higher metabolic demand and central responses (e.g., oxygen uptake, breathing rate, etc.) of this exercise modality, albeit our data were consistent with this effect being trivial to very large. Differences in favour of a higher rating of leg-exertion (dRPE-L) for cycling were more certain (small to large effects), and accompanied a greater reduction in MVC after this mode of exercise with similar certainty (small to large). Our use of dRPE therefore offered a potentially sensitive measure capable of differentiating between the specific central and peripheral inputs during HIIT (Mclaren et al. Understanding the neuromuscular response to short-duration HIIT is necessary because of the potential impact on subsequent training sessions (Leveritt and Abernethy The study is not without limitations. First, the use of male university standard team sport athletes means that our findings might not translate directly to those athletes of a higher or lower standard or to female participants. Given the task-dependent nature of fatigue (Enoka and Duchateau | PMC9813096 | |
Conclusion | This study examines the responses to a specific HIIT training session using cycle ergometry and running in team sport athletes, offering valuable insight to those team sport practitioners using cycle-based training with their athletes. These data highlight cycling elicited lower responses compared to running during short-duration (15 s) high intensity interval training. The time above the threshold for adaptation (i.e., > 90% | PMC9813096 | ||
Author contributions | CT and JH conceived and designed research. RB, CT and JH conducted experiments. CT and JH analyzed data. CT wrote the manuscript. All authors read and approved the manuscript. | PMC9813096 | ||
Funding | This project did not receive any funding. | PMC9813096 | ||
Declaration | PMC9813096 | |||
Conflict of Interest | The authors declare that they have no conflict of interest. | PMC9813096 | ||
References | PMC9813096 | |||
Abstract | Presented to the ASCO Virtual Annual Meeting, June 2021 (Abstract ID 3598). | PMC10338899 | ||
Background | Evidence is lacking regarding the earliest timing of initiating adjuvant chemotherapy to maximize its efficacy safely. A trial was designed and conducted to evaluate the safety and oncological efficacy of early adjuvant chemotherapy compared with conventional adjuvant chemotherapy. The short-term outcomes are reported here. | PMC10338899 | ||
Methods | Toxicity | STAGE II COLON CANCER | A multicentre, randomized (1 : 1), open-label, phase III trial was conducted comparing early adjuvant chemotherapy with conventional adjuvant chemotherapy in patients with stage III colon cancer. Patients who underwent radical surgery who had stage III colon cancer confirmed by histopathological assessment were screened and randomized into the early adjuvant chemotherapy arm or the conventional adjuvant chemotherapy arm. The primary endpoint was 3-year disease-free survival. The adjuvant chemotherapy with FOLFOX was delivered between postoperative day 10 and 14 in the early adjuvant chemotherapy arm, and between postoperative day 24 and 28 in the conventional adjuvant chemotherapy arm. Toxicity and quality of life were evaluated. | PMC10338899 |
Results | toxicity | Between 9 September 2011 and 6 March 2020, 443 patients consented to randomization at eight sites. The intention-to-treat population included 423 patients (209 in the early adjuvant chemotherapy arm and 214 in the conventional adjuvant chemotherapy arm), and the safety population included 380 patients (192 in the early adjuvant chemotherapy arm and 188 in the conventional adjuvant chemotherapy arm). There was no statistically significant difference in overall toxicity (28.1 per cent in the early adjuvant chemotherapy arm and 28.2 per cent in the conventional adjuvant chemotherapy arm, | PMC10338899 | |
Conclusion | toxicity | SURGICAL COMPLICATIONS, STAGE II COLON CANCER | Adjuvant chemotherapy can be safely initiated 2 weeks after surgery with toxicity and quality of life comparable to conventional adjuvant chemotherapy for stage III colon cancer.The aim of this study was to evaluate the safety of early initiation of adjuvant chemotherapy within 2 weeks after surgery in patients with stage III colon cancer. Findings revealed that there was no statistically significant difference in overall toxicity, surgical complications, and quality of life between the early and conventional adjuvant chemotherapy arms. | PMC10338899 |
Introduction | tumour, colon cancer | TUMOUR, COLON CANCER | Adjuvant chemotherapy (AC) after radical surgery is the current standard treatment for high-risk stage II and III colon cancer with a survival benefit due to eradication of micrometastasesMany preclinical studies suggest that surgery due to manipulation of the tumour may affect tumour kinetics, facilitate circulation of tumour cells, and increase metastatic potentialAlthough the negative impact of delaying AC is evident, initiating AC immediately after surgery for colon cancer has been avoided. This is due to concerns that cytotoxic agents can compromise tissue healing of wounds and the anastomosis. Patients need enough time to recover to be able to tolerate cytotoxic therapy safely. However, the postoperative recovery interval has been reduced due to minimally invasive surgery and Enhanced Recovery After Surgery (ERAS) protocols. Therefore, more patients should be physiologically able to tolerate AC earlier than in the past.Most previous studies have focused on how long you can delay AC rather than how early is safe. Therefore, a prospective randomized trial was designed and conducted to evaluate the safety and oncological efficacy of early AC (EAC) compared with conventional AC (CAC). In this study, the short-term outcomes of this trial are reported. | PMC10338899 |
Methods | PMC10338899 | |||
Study design and participants | AJCC Cancer, tumours, malignancy, colorectal surgeons, non-cancer-related disease, perforation, tumour obstruction, hypersensitivity, unresectable disease | ADENOCARCINOMA OF THE COLON, TUMOURS, POSTOPERATIVE COMPLICATIONS, COLON CANCER, CANCER; METASTATIC, ONCOLOGY, STAGE II COLON CANCER, HYPERSENSITIVITY | A multicentre, randomized (1 : 1), open-label, phase III trial was conducted comparing EAC with CAC in patients with stage III colon cancer. Patients were recruited from eight centres in South Korea. All centres were tertiary medical institutes with sub-specialist colorectal surgeons. Patients with stage III colon cancer were screened after surgery to determine whether they met the inclusion criteria: age greater than or equal to 18 years with Eastern Cooperative Oncology Group (ECOG) performance status 0–2; histologically confirmed adenocarcinoma of the colon (tumours greater than 12 cm from the anal verge or above the peritoneal reflection); undergone standard, minimally invasive, curative R0 resection with D3 lymphadenectomy; discharged within 10 days after surgery; stage III based on the Seventh Edition of the AJCC Cancer Staging Manual; fully recovered hepatic, renal, and haematological function, as assessed by serum chemistry with calculated creatinine clearance, liver function test, and full blood cell count; and able to understand and willing to consent. The main exclusion criteria were: rectal cancer; metastatic or radically unresectable disease; stage I or II colon cancer based on the Seventh Edition of the AJCC Cancer Staging Manual; any contraindication for chemotherapy, including age greater than 85 years or life expectancy under 5 years due to non-cancer-related disease; hypersensitivity to treatment component(s); unable to be discharged 10 days after surgery due to any postoperative complications; emergency operation for tumour obstruction or perforation; history or presence of synchronous malignancy; previous chemotherapy; and being pregnant or breastfeeding.The study was conducted as per the Declaration of Helsinki and the Good Clinical Practice guidelines. The study protocol was approved by the Kyungpook National University Hospital Ethics Committee (version 1.3) on 21 January 2012, and its equivalent in other participating institutions. All participants provided written informed consent before enrolment. Trial oversight was maintained by a combined trial steering committee and a data monitoring committee. This study was registered at ClinicalTrials.gov (NCT01460589). | PMC10338899 |
Randomization and procedure protocol | stomatitis, malignancy, death, Cancer | ADVERSE EVENT, RECURRENCE, STOMATITIS, ADVERSE EVENTS, ADVERSE EVENT, DISEASE, EVENT, CANCER | The anaesthetic evaluation and patient information regarding the operative procedure were performed according to the local practices of each investigation centre. Radical surgery was performed as per the oncological quality criteria for resection. Preoperative and postoperative data were reported on specific forms. If the histological assessment confirmed stage III disease and the patient met the inclusion criteria, eligible patients were randomly assigned (1 : 1) to the EAC arm or the CAC arm. The randomization sequence was concealed from the investigators, and randomization was performed using a web-based software platform (Velos, Fermont, CA, USA) and centrally coordinated by the Clinical Research Coordination Centre of the Kyungpook National University Cancer Centre (Daegu, Korea).The assigned AC was delivered between postoperative day (POD) 10 and 14 in the EAC arm, and between POD 24 and 28 in the CAC arm. The AC regimen was FOLFOX, which comprised oxaliplatin 85 mg/mToxicity was evaluated based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0, and dose modifications were based on the most severe adverse events and the investigator’s discretion. Adverse events were monitored during and after the study treatment, and a complete laboratory examination was performed on day 1 of each treatment cycle. For treatment-related adverse events of grade 1, treatment was continued at the total dose. For grade 2, treatment was withheld and restarted after recovery to grade 1. The dose was reduced for grade 3 adverse events and grade 4 stomatitis with a delay in the treatment schedule, if necessary. Treatment was discontinued in the event of any documented disease recurrence, grade 4 or 5 adverse events, or a patient’s refusal.After completing the protocol treatment, patients were followed up according to a predefined surveillance schedule until recurrence, development of another malignancy, or death. Carcinoembryonic antigen level assessment with a general blood test and abdominopelvic CT scans were performed every 3 to 6 months for the first 2 years and every 6 months thereafter. Chest CT scans were performed every 8 to 12 months. A colonoscopy was routinely performed 1 year and 5 years after surgery. | PMC10338899 |
Endpoints | death, Cancer | RECURRENCE, ADVERSE EVENTS, SECONDARY, SURGICAL COMPLICATIONS, CANCER | The primary endpoint was 3-year DFS, defined as the time from the date of the operation to the earliest date of recurrence.The secondary endpoint was OS, defined as the time from the date of the operation to the date of death due to all causes or the date of the last follow-up, chemotherapy-related adverse events according to CTCAE 4.0, surgical complications during chemotherapy according to the Clavien–Dindo classification, and quality of Life (QoL) assessment according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30. The patients completed baseline questionnaires after providing consent and before initiating AC. When patients visited the outpatient clinic, follow-up questionnaires were administered to patients 1, 3, 6, and 12 months after surgery.The review of case report forms was conducted annually for quality control by the Kyungpook National University Cancer Centre (Daegu, Korea). | PMC10338899 |
Statistics | The expected 3-year DFS with CAC was 72 per cent based on a literature reviewAll randomized patients were defined as the intention-to-treat (ITT) population. Patients with protocol violations, which meant the date of initiating chemotherapy did not meet the protocol, were excluded from the per-protocol population. Safety analyses were performed on the safety population, which meant all patients who received at least one cycle of chemotherapy after randomization. QoL analyses were performed on patients in the safety population who answered QoL questionnaires at baseline and follow-up.The χStatistical analyses were performed using SPSS | PMC10338899 | ||
Results | PMC10338899 | |||
Patient and disease characteristics | LATE SURGICAL COMPLICATION | Between 9 September 2011 and 6 March 6 2020, 443 patients consented to randomization at eight sites; 221 and 222 patients were allocated to the EAC arm and the CAC arm respectively (Flow diagram of study populationEAC, early adjuvant chemotherapy; CAC, conventional adjuvant chemotherapy.A total of 43 patients (17 in the EAC arm and 26 in the CAC arm) did not receive treatment as per the study protocol. In the EAC arm, two patients could not initiate AC due to the late surgical complications, and 39 patients (15 in the EAC arm and 24 in the CAC arm) received other regimens for AC, including intravenous fluorouracil/leucovorin (FL), oral capecitabine, and oxaliplatin with oral capecitabine. The safety population included 380 patients (192 in the EAC arm and 188 in the CAC arm) because safety data were missing for 2 patients in the CAC arm. The QoL population included 280 patients (148 in the EAC arm and 132 in the CAC arm) because QoL data were missing for 100 patients (44 in the EAC arm and 56 in the CAC arm) among the safety population.The baseline and pathological characteristics of the ITT population, the safety population, and the QoL population are shown in Baseline characteristicsValues are | PMC10338899 | |
Results of adjuvant chemotherapy and toxicity | toxicity, anastomotic stricture | SURGICAL COMPLICATIONS, RECURRENCE, LEAKAGE | The median times from operation to initiating AC were 13 (range 4–43) days in the EAC arm and 29 (range 17–53) days in the CAC arm (safety population) (Results of adjuvant chemotherapyValues are The median number of administered cycles and completeness of chemotherapy, including the rate of completion without dose reduction or delay, the rate of completion with dose reduction or delay, the rate of completion of FL with discontinuation of oxaliplatin, and the rate of discontinuation of chemotherapy, were similar between the two arms. The most common reason for discontinuation of chemotherapy was toxicity in both arms, and five patients in the CAC arm had to discontinue the study protocol treatment and change to another chemotherapeutic regimen due to recurrence, compared with no recurrence during AC in the EAC arm.Although there were two cases of postoperative surgical complications in the EAC arm (one case of anastomotic leakage and one case of anastomotic stricture) compared with none in the CAC arm, there was no statistically significant difference (1.0 per cent in the EAC arm The relative dose intensities of oxaliplatin in the two arms were similar and decreased to 80 per cent at the seventh cycle of AC in both arms (Relative oxaliplatin dose intensity during each cycle (safety population)*The ratio of the median of the actual dose to the initial dose that is recommended by guidelines. EAC, early adjuvant chemotherapy; CAC, conventional adjuvant chemotherapy,Details of toxicity are presented in | PMC10338899 |
Quality of life | The QoL data are shown in Comparison of quality of life between the early adjuvant chemotherapy arm and the conventional adjuvant chemotherapy arm
| PMC10338899 | ||
Discussion | colorectal cancer, patientsAnastomotic leakage, toxicities, colorectal surgeons, colon cancer, colorectal resection | COLORECTAL CANCER, GASTROINTESTINAL CANCERS, RECURRENCE, POSTOPERATIVE COMPLICATIONS, COLON CANCER, STRICTURE, SURGICAL COMPLICATIONS, LEAKAGE, COMPLICATIONS | Traditionally, AC is initiated between 4 and 8 weeks after radical surgery for colon cancer to achieve the balance between postoperative recovery and therapeutic effect. Although many studies have reported a correlation between poor prognosis and late initiation of AC (more than 8 weeks postoperatively)In the era of minimally invasive surgery and ERAS, it is necessary to re-evaluate traditional chemotherapy regimens. The traditional concept of AC after a minimum of 4 weeks after surgery was formed several decades ago when open surgery was generally performed for gastrointestinal cancers. This demanded longer hospitalization, recovery time (until returning to oral intake), and wound management. However, minimally invasive surgery for colorectal cancer has now become the standard of care for the majority of patientsAnastomotic leakage, one of the worst complications following colorectal surgery, is usually diagnosed between 3 and 8 days after surgeryA potential concern after the early introduction of cytotoxic agents is late anastomotic complications. In this study, two patients in the EAC arm showed leakage on POD 16 and a stricture on POD 18 respectively, and both required surgical intervention. Although it is generally considered that anastomotic healing is completed by POD 10–12, the rate of late anastomotic leakage after general recovery was reported to be 6 to 7.7 per cent in colorectal resection, regardless of the timing of ACThere were five cases of recurrence during AC in the CAC arm and no cases in the EAC arm. These findings need to be evaluated further with longer-term follow-up and to investigate if patients with adverse features should be considered for earlier AC.In the present study, postoperative QoL was investigated to evaluate if a shorter interval between surgery and following AC impairs general condition and daily living according to a patient’s subjective feelings, in addition to surgical complications. AC affects the QoL of patients who undergo colon cancer surgery, not only during AC, but also after its completionThis study has limitations. The time interval between the two arms according to the study design was only 2 weeks. Due to the short interval between the two arms and various medical and personnel issues, there was an overlap of the time interval. Consequently, interpretation of the results should be made with some caution as 58 patients (25 in the EAC arm and 33 in the CAC arm) were excluded from the safety analyses because of protocol violations. Among them, 15 patients were enrolled in the study by surgeons immediately after recovery from surgery, but all declined to receive chemotherapy after discussions with medical oncologists. Another 40 patients chose a chemotherapy regimen other than FOLFOX. However, the outcomes of variables (chemotherapy dose, compliance, and toxicities) analysed in the safety population were similar when analyses including those patients were performed.This study was performed in tertiary hospitals with sub-specialist colorectal surgeons, high rates of minimally invasive surgery, and low rates of surgical complications. This might impact the generalizability of the results to other centres nationally or internationally. Early initiation of AC is not appropriate for all patients and may not be appropriate for those who have open surgery, frail patients, or those with postoperative complications. | PMC10338899 |
Supplementary Material | Click here for additional data file. | PMC10338899 | ||
Acknowledgements | J.Y.K. and J.S.P. contributed equally to this study as co-corresponding authors. K.H.L. and S.Y.P. contributed equally to this study as co-first authors. | PMC10338899 | ||
Funding | This study was supported by the International Colorectal Research Summit Grant 2015 and sponsored by the Korean Society of Coloproctology; the National Research Foundation of Korea (NRF). A grant was provided by the South Korean government (Ministry of Science and ICT, South Korea) (Grant No. 2021R1A5A2021614). | PMC10338899 | ||
Author contributions | Kyung Ha Lee (Investigation, Resources, Visualization, Writing—original draft, Writing—review & editing), Soo Yeun Park (Data curation, Formal analysis, Investigation, Resources, Software, Validation, Visualization, Writing—original draft), Seung Ho Song (Investigation, Writing—review & editing), Hye Jin Kim (Investigation, Writing—review & editing), Jong Gwang Kim (Investigation, Writing—review & editing), Byung Woog Kang (Investigation, Writing—review & editing), In Kyu Lee (Investigation, Writing—review & editing), Yoon Suk Lee (Investigation, Writing—review & editing), So Hyun Kim (Investigation, Writing—review & editing), Seong Kyu Baek (Investigation, Writing—review & editing), Sung Uk Bae (Investigation, Writing—review & editing), Gyung Mo Son (Investigation, Writing—review & editing), Ki Beom Bae (Investigation, Writing—review & editing), Gyu-Seog Choi (Conceptualization, Funding acquisition, Investigation, Resources, Supervision, Writing—review & editing), Jun Seok Park (Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Visualization, Writing—review & editing), and Ji Yeon Kim (Conceptualization, Investigation, Supervision, Writing—review & editing). | PMC10338899 | ||
Disclosure | The authors declare no conflict of interest. | PMC10338899 | ||
Supplementary material | PMC10338899 | |||
Data availability | The data are available upon contact with the authors. | PMC10338899 | ||
References | PMC10338899 | |||
Subject terms | trunk flexor, Pain, Oswestry Disability, pain, lumbar multifidus muscle thickness, disability | SECONDARY | This study investigated the effectiveness of an early aquatic exercise program on trunk muscle function and functional recovery of patients with lumbar fusion. Twenty-eight subjects were divided into two equal groups. Patients in the aquatic group performed two 60-min aquatic exercise sessions and three 60-min home exercise sessions per week for 6 weeks, whereas those in the control group performed five sessions of 60-min home exercises per week for 6 weeks. The primary outcomes were the Numerical Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI), and the secondary outcomes were Timed Up and Go Test (TUGT), trunk flexor and extensor muscle strength, lumbopelvic stability, and lumbar multifidus muscle thickness measured pre- and post-intervention. Compared with participants in the control group, those in the experimental group showed significant improvement in NPRS, ODI, trunk extensor strength, lumbopelvic control, lumbar multifidus muscle thickness, and relative change in multifidus muscle thickness (significant time by group interactions, P < 0.05). Participants in both groups showed significant time effects (P < 0.001) for TUGT and trunk flexor strength outcome. Aquatic exercise combined with home exercise was superior to home exercise alone in reducing pain, disability and improving muscle strength, lumbopelvic stability, and lumbar multifidus muscle thickness. | PMC10317955 |
Introduction | disability, stenosis, trunk muscle, pain | DEGENERATIVE CHANGE, STENOSIS | Lumbar fusion is a common spine surgery often performed to relieve symptoms related to spinal degenerative changes, stenosis, and spondylolisthesisExercise in water, compared with that on land, reduces loadTherefore, through this study, we aimed to examine the effects of an early aquatic rehabilitation program on pain, disability, trunk muscle strength, lumbopelvic stability, and lumbar multifidus (LM) muscle thickness following lumbar spine fusion. We hypothesized that a 6-week aquatic rehabilitation program would significantly improve trunk muscle strength, lumbopelvic stability, and LM muscle thickness and reduce pain and disability in patients who have undergone lumbar fusion. | PMC10317955 |
Discussion | pain, disability, LM muscle thickness, lumbopelvic, trunk muscle function | To the best of our knowledge, this is the first study to investigate the effects of an early aquatic rehabilitation program on pain, disability, and trunk muscle function following lumbar spine fusion. Our data supported most of the hypotheses, with the 6-week aquatic rehabilitation program significantly improving trunk muscle strength, lumbopelvic stability, and LM muscle thickness, and reducing pain and disability in patients after lumbar fusion compared with the home exercise program.Significant improvement in pain score was observed only in the experimental group. Although no research has been performed on the effects of aquatic exercise for lumbar fusion, similar pain relief effects of aquatic exercise intervention were observed in patients after total knee and hip replacementIn this study, both the aquatic rehabilitation program and home exercise program significantly improved the disability score, although better results were observed with aquatic exercise than with home exercise. We observed a 37.82% decrease in ODI in the experimental group, which was better than the previously reported data (18% and 36%)The TUGT is an assessment tool that reflects the lower extremity function and the static and dynamic balance of patients who undergo lumbar fusion. This assessment also evaluates movements necessary for ambulation in daily lifeThe experimental group exhibited significantly improved trunk extensor strength. After surgery, the trunk extensor muscle is damaged, and the patient is typically afraid to do land exercises. However, the buoyancy of water can reduce the body’s weight and load on the muscle. This can help overcome the sense of fear and pain experienced by patients that typically lead to reduced movement, thereby enhancing their willingness to move in the water. In addition, an aquatic environment may allow patients to perform exercises to reestablish motor control without exacerbating their symptomsThe lumbopelvic stability test revealed a significant intervention effect between patients in the experimental and control groups. Studies have shown that strengthening the lumbar stabilizer muscles such as transverse abdominis and multifidus can improve trunk control abilityA recent study, conducted in 2021, reported that hip abductor strengthening exercises can increase the size of LM musclesSeveral limitations of this study may partially interfere with the results. First, as the study lacked a long-term follow-up, it is unclear whether the observed improvements could be maintained for a longer period of time. Second, the study was not blinded, and thus, the outcome could not entirely exclude bias in the measurement of results. Finally, although the exercise frequency of the participants in the control group was recorded, no therapist supervised their exercises, whereas the participants in the experimental group were supervised twice while they received their aquatic exercise training. Hence, it is unclear whether the positive effects are attributable to hydrotherapy or supervision. | PMC10317955 | |
Methods | PMC10317955 | |||
Trial design | This was an experimental, randomized controlled trial. Participants were randomly allocated to an experimental group or a control group for 6 weeks of intervention. This study was approved by the Institutional Review Board of Cheng Hsin General Hospital (425-103-02) and registered on 13/11/2016 at Thai Clinical Trials (registration number TCTR20161113001) and consistent with the CONSORT checklist. All experiments were performed in compliance with applicable guidelines and regulations. | PMC10317955 | ||
Participants | cardiovascular disease, cognitive dysfunction | CARDIOVASCULAR DISEASE, NEUROLOGICAL DISORDERS | Twenty-eight patients who underwent surgery with lumbar fusion and were referred from the Department of Orthopedics to the Department of Rehabilitation of the Cheng Hsin General Hospital for physiotherapy between October 2014 and December 2016 were recruited. Participants scheduled for first lumbar fusion surgery, those aged between 20 and 65 years, and those with unilateral leg symptoms prior to surgery were included. Those who had previously undergone back surgeries; those with severe cardiovascular disease, neurological disorders, or cognitive dysfunction; and pregnant patients were excluded. All participants signed written informed consent forms before participation. All data were collected at the Department of Rehabilitation in Cheng Hsin General Hospital. | PMC10317955 |
Sample size and randomization | Oswestry Disability | The sample size was calculated using the G*Power software, with alpha = 0.05 and 80% power for the outcome of the Oswestry Disability Index (ODI) by using the formula proposed by Abbott | PMC10317955 | |
Intervention | MAY, APPENDIX | Participants from both groups started the 6-week intervention 4 weeks after surgery. Those in the experimental group received two sessions of 60-min aquatic training, with three 60-min sessions of home exercises each week for 6 weeks, whereas those in the control group performed home exercises only (five 60-min sessions each week for 6 weeks). The aquatic pool was 7 m wide and 10 m long, with a graded depth from 0.9 to 1.3 m. The temperature of the pool was set at 34–36 °C, and the therapist and participant ratio was 1:2. A physiotherapist with 8 years of experience in aquatic therapy provided the aquatic training sessions. This intervention was administered from January 2015 to May 2016.The aquatic exercise protocol consisted of 5 min of warm-up with stretching of the leg muscles and walking in water, 50 min of main exercises, and 5 min of cooldown stretching exercises (Online Appendix | PMC10317955 | |
Outcome measures | disability, Pain, pain | SECONDARY, CONTRACTION | The primary outcomes were pain intensity and disability, and the secondary outcomes were mobility, muscle strength, lumbopelvic stability, and LM muscle thickness. The measurement of secondary outcomes and evaluation of exercise intervention were performed by the first author (AH Huang), and the primary outcomes were evaluated by a physiotherapist with 5 years of working experience, who was blinded to the grouping of the participants.Pain intensity was assessed using the Numerical Pain Rating Scale (NPRS). The NPRS is an 11-point scale from 0 to 10, with 0 indicating “pain free” and 10 indicating “the worst painThe Timed Up and Go Test (TUGT) was used to assess the patients’ mobility. This test starts with the patient seated on a chair. At the start signal, the patient is instructed to stand up and walk as fast as possible for 3 m, turn, walk back to the chair, and return to the seated position. The time was recorded by a handheld stopwatch. Two trials were performed, and the best recorded time was used for analysisThe isometric muscle strength of the trunk extensors and flexors was measured in the sitting position using a hand-held dynamometer (MicroFET2; HOGGAN, Atlanta, GA, USA)Hip movement range was used to indicate the level of control of the lumbopelvic stability during the one-leg loading test in the supine positionRehabilitation ultrasound image measurement of the LM muscle thickness was conducted using a Philips HD11 XE ultrasound imaging apparatus with a 5–12-MHz linear transducer (Philips Medical Systems, Bothell, WA, USA). The participants were positioned in prone, with a pillow placed under the lower abdominals to minimize lumbar lordosisTo determine the relative variation of individual muscle thickness, the thickness value obtained in each contraction task was subtracted from the value obtained when the LM muscle was in the resting position and then divided by the value in the resting position. | PMC10317955 |
Statistical analysis | Data were analyzed using SPSS (version 20 for Mac; SPSS Inc., Chicago, IL, USA). Independent | PMC10317955 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-37237-3. | PMC10317955 | ||
Acknowledgements | This study was supported by a grant from Cheng Hsin General Hospital, Taipei, Taiwan (CH-104-18). This manuscript was edited by Wallace Academic Editing. The authors appreciate all participants for their contribution. | PMC10317955 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.