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RESULTS | The AG and CG, respectively, completed 91 ± 12% and 99 ± 4% of the planned training sessions. All subjects allocated to either training intervention completed ≥75% of the training sessions and were included in the analyses. | PMC10680576 | ||
Distribution of fat mass, lean mass, and anthropometry | SE | No difference between the groups at baseline was observed (Table Distribution of fat mass, lean mass, and anthropometry before and after 10 weeks of abdominal and treadmill aerobic endurance exercise.
Abbreviations: AG, abdominal aerobic endurance exercise group; BMI, body mass index; CG, control group.Distribution of ... | PMC10680576 | |
Maximal oxygen uptake and maximal muscle strength | In both groups, absolute (AG: 0.26 ± 0.28 L minMaximal oxygen uptake and maximal muscle strength before and after 10 weeks of abdominal and treadmill aerobic endurance exercise.
Abbreviations: AG, abdominal aerobic endurance exercise group; CG, control group; HRTorso rotation 1RM increased more (25 kg, 27%, | PMC10680576 | ||
DISCUSSION | overweight | It has been well accepted that exercise‐induced lipolysis occurs predominantly through whole‐body fat release, rather than from local adipose tissue storages adjacent to the working muscles. However, to date no study has investigated the concept of spot reduction/lipolysis by comparing abdominal aerobic endurance train... | PMC10680576 | |
Spot versus generalized fat reduction during abdominal aerobic endurance training | In contrast to our hypothesis, the current study found that fat mass stored in the trunk decreased more in the AG than in the CG. In fact, intragroup analyses showed that trunk fat mass decreased by 1170 g (7%) in the AG, with no detectable change observed in the CG. To the best of our knowledge, our study is the first... | PMC10680576 | ||
Spot reduction, intensity, and metabolic versus circulatory demands | McArdle, lean mass | MCARDLE | It remains unclear whether the effects observed in the current study are predominantly related to metabolic or circulatory mechanisms during training or recovery after exercise. The rate of peripheral adipocyte lipolysis, from subcutaneous or visceral adipose tissue, is documented to be highest during exercise with low... | PMC10680576 |
Clinical implications and limitations | muscle mass | Each full training session in the AG, combining treadmill and abdominal aerobic endurance exercise, lasted in total 84 min, almost double the duration compared to the moderate intensity treadmill intervention in the CG. The smaller muscle mass used in the abdominal endurance exercise, as compared to whole‐body treadmil... | PMC10680576 | |
CONCLUSIONS | overweight | The current randomized controlled trial provides evidence that aerobic endurance training of a specific body segment may in fact lead to increased utilization of adipose tissue locally stored. Specifically, our data highlight that 10 weeks of aerobic endurance training of the abdominal region, with relatively high inte... | PMC10680576 | |
AUTHOR CONTRIBUTIONS | Jan Helgerud and Jan Hoff conceived and designed the study. Iben Krogsæter conducted the experiments. Iben Krogsæter, Jan Hoff, Eivind Wang, and Mathias Forsberg Brobakken analyzed the data. Mathias Forsberg Brobakken and Eivind Wang wrote the manuscript. All authors critically read, revised, and approved the manuscrip... | PMC10680576 | ||
CONFLICT OF INTEREST STATEMENT | None. | PMC10680576 | ||
ETHICS STATEMENT | The study was approved by the institutional review board for medical and health research ethics ( | PMC10680576 | ||
Supporting information |
Data S1.
Click here for additional data file. | PMC10680576 | ||
ACKNOWLEDGMENTS | The authors thank the participants for their time and effort during this study. No funding was received for conducting this study or to assist with the preparation of this manuscript. | PMC10680576 | ||
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10680576 | ||
REFERENCES | PMC10680576 | |||
Objectives | MM | To investigate the effect of a device-assisted suction against resistance Mueller maneuver (MM) on transient interruption of contrast (TIC) in the aorta and pulmonary trunk (PT) on computed tomography pulmonary angiogram (CTPA). | PMC10598181 | |
Methods | pulmonary artery embolism, MM | PULMONARY ARTERY EMBOLISM | In this prospective single-center study, 150 patients with suspected pulmonary artery embolism were assigned randomly with two different breathing maneuvers (Mueller maneuver (MM) or standard end-inspiratory breath-hold command (SBC)) during routine CTPA. The MM was performed using a patented prototype (Contrast Booste... | PMC10598181 |
Results | MM | Overall, patients with MM showed an attenuation of 338.24 HU in the pulmonary trunk, compared to 313.71 HU in SBC ( | PMC10598181 | |
Conclusions | Performing the MM with the application of the prototype is an effective way of preventing the TIC phenomenon during i.v. contrast-enhanced CTPA scanning compared to the standard end-inspiratory breathing command. | PMC10598181 | ||
Clinical relevance | MM | PULMONARY EMBOLISM | Compared to standard end-inspiratory breathing command, the device-assisted Mueller maneuver (MM) improves contrast enhancement and prevents the transient interruption of contrast (TIC) phenomenon in CTPA. Therefore, it may offer optimized diagnostic workup and timely treatment for patients with pulmonary embolism. | PMC10598181 |
Key Points | PMC10598181 | |||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10598181 | ||
Introduction | pulmonary artery embolism, VTE, venous thromboembolism | PULMONARY ARTERY EMBOLISM, SECONDARY, DEEP VEIN THROMBOSIS | The clinical picture of pulmonary artery embolism secondary to deep vein thrombosis falls under the term venous thromboembolism (VTE) [In case of a suspected PE, laboratory testing of D-Dimer is often performed. In this context, the sensitivity of different point-of-care tests is reported as above 90%, however, specifi... | PMC10598181 |
Materials and methods | PMC10598181 | |||
Sample size estimation | MM | Based on a one-sided Fisher’s exact test and prevalence of TIC phenomenon of 5% in the MM (Mueller maneuver) group compared to 20% in SBC (standard breathing command) group, an assumed | PMC10598181 | |
Patient collective and study design | pulmonary artery embolism, breathing impairment, MM | HEARING IMPAIRMENT, PULMONARY ARTERY EMBOLISM | In our prospective, institutional-review-board-approved (2019-400 M-§23bMPG) single-center study, patients with suspected pulmonary artery embolism were enrolled and randomly assigned into two groups (MM and SBC) with different breathing maneuvers during routine CTPA. Patients were enrolled based on the following crite... | PMC10598181 |
Computed tomography imaging acquisition and reconstruction | CTPA was performed on a 128-slice single-source CT scanner system (SOMATOM Definition AS + , Siemens Healthcare GmbH). Scanning was performed in the cranio-caudal direction. A total of 60 ml iodine-based contrast agent (75% Imeron 350, Bracco, 25% NaCl 0.9%) was applied with a flow rate at 4 mL/s followed by a NaCl cha... | PMC10598181 | ||
Device and inspiration maneuver | PMC10598181 | |||
Group 1: Mueller maneuver | inferior vena cava, PIU | CAVITY, CONTRACTION | The Mueller maneuver was performed using a dedicated prototype Contrast Booster system (Contrast Booster™ System, Ulrich GmbH & Co. KG) which allows both the patient via bio-feedback and the radiological staff outside the scanner room to monitor the correct performance of the Mueller maneuver throughout the scan and in... | PMC10598181 |
Group 2: Standard breathing command | –20 mmHg), inferior vena cava | CAVITY | The control group had to follow a standard automated breathing command telling the patient just shortly before the scan started “Please breathe in and hold your breath” and after completion of the scan “Continue breathing.”The applied approach and complex physiological implications are summarized in Fig. Mueller maneuv... | PMC10598181 |
Image analysis | pulmonary embolism, Aycan | PULMONARY EMBOLISM | Image analysis was performed in a dedicated PACS-viewer solution (Aycan workstation PRO, Version 3.14.006, Aycan Medical Systems LLC). ROIs were placed in both the pulmonary trunk and the descending aorta at the transverse level of the pulmonary trunk by a radiology resident with 5 years of experience in CT imaging.The... | PMC10598181 |
Statistical analysis | Statistical analysis was performed with dedicated statistical analytics software (R statistics, version 4.1.0) [ | PMC10598181 | ||
Results | PMC10598181 | |||
Patient recruitment | pulmonary artery embolism | PULMONARY ARTERY EMBOLISM | Based on the inclusion criteria, 151 patients each with a suspected pulmonary artery embolism were enrolled and randomly assigned to two study groups with different breathing maneuvers. One patient withdrew from the CTPA examination and the study at his own request before the CT scan was performed. Therefore, the final... | PMC10598181 |
Comparison of Mueller maneuver and standard breathing command | pulmonary embolism | PULMONARY EMBOLISM | There were no significant differences in age, sex, and rate of pulmonary embolism between both study groups (all Patient collective and group comparisonHU in pulmonary trunc(mean (SD))HU in descending aorta(mean (SD))The mean CT attenuation in the pulmonary trunk was 338.24 HU (SD 102.07) in the MM group compared to 31... | PMC10598181 |
Discussion | pulmonary embolism, sub-collectives, MM | PULMONARY EMBOLISM | This prospective study showed that the performance of the device-assisted Mueller maneuver (MM) compared to the standard breathing command (SBC) did in tendency increase contrast attenuation in the pulmonary trunk in CTPA studies. Furthermore, the presence of the TIC phenomenon was reduced significantly to 0% in this s... | PMC10598181 |
Funding | Open Access funding enabled and organized by Projekt DEAL. The authors state that this work has not received any funding other than provision of the device prototype by ulrich GmbH & Co. KG. | PMC10598181 | ||
Declarations | PMC10598181 | |||
Guarantor | PD | The scientific guarantor of this publication is PD Dr. Matthias Frölich. | PMC10598181 | |
Conflict of interest | Niklas | The authors of this manuscript declare relationships with the following companies: Ulrich GmbH & Co. KG, Ulm, Germany.Niklas von Münchhausen—no conflicts of interest related to this work.Sonja Janssen—Medical Advisor ulrich GmbH & Co. KG.Johann S Rink—no conflicts of interest related to this work.Daniel Overhoff—no con... | PMC10598181 | |
Statistics and biometry | No complex statistical methods were necessary for this paper. | PMC10598181 | ||
Informed consent | Written informed consent was obtained from all subjects (patients) in this study. | PMC10598181 | ||
Ethical approval | Institutional Review Board approval was obtained. | PMC10598181 | ||
Study subjects or cohorts overlap | None of the study subjects or cohorts have been previously reported. | PMC10598181 | ||
Methodology | • prospective• randomised controlled trial / diagnostic or prognostic study• performed at one institution | PMC10598181 | ||
References | PMC10598181 | |||
Methods | TYPE 2 DIABETES MELLITUS | This multicenter, randomized, open-label, controlled study enrolled 100 adult patients with type 1 or type 2 diabetes mellitus (A1C ≥ 6.5% and ≤ 9.5%, i.e., 48 to 80 mmol/mol) who were assigned with the Omnipod or with the A7+TouchCare pump for 3 months. The primary study outcome was the glucose management indicator (G... | PMC10449223 | |
Results | diabetes | PREMATURE, DIABETES | Premature withdrawals occurs respectively in 2 and 9 participants in the Omnipod and TouchCare groups. In the Per Protocol analysis, the difference in GMI between groups was 0.002% (95% confidence interval -0.251; 0.255). The non-inferiority was demonstrated since the difference between treatments did not overlap the p... | PMC10449223 |
Conclusions | This study showed that the A7+TouchCare insulin pump was as efficient as the Omnipod pump in terms of performance and satisfaction. | PMC10449223 | ||
Clinical trail registration | The study was registered in the ClinicalTrials.gov protocol register ( | PMC10449223 | ||
Data Availability | Ethical and legal restrictions apply to the data as public data-sharing was not planned in the information letter given to and signed by participants at inclusion in the study. Data-sharing would therefore require an amendment of the information given to patients after acceptance by the ethics committee and then partic... | PMC10449223 | ||
Introduction | T2D, diabetes mellitus, T2D), T1D, hypoglycemic, Diabetes, diabetes | DIABETES, EVENTS, DIABETES MELLITUS, DIABETES | Treatment of patients with type 1 (T1D) and some type 2 (T2D) diabetes mellitus is based on insulin therapy in order to mimic the physiological pancreatic secretion according to a basal/bolus pattern obtained either by multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) with an external i... | PMC10449223 |
Materials and methods | PMC10449223 | |||
Study design and patients | DIABETES MELLITUS | This was a multicenter, randomized, open-label comparative study. The study was conducted between February 2020 and February 2021 in 8 hospital centers in France that recruited patients. The randomization was done in two parallel groups (1:1), with a stratified randomization by center with randomized blocks of 4. Rando... | PMC10449223 | |
Pump characteristics | The A7+TouchCare pump dimensions are 56.3x33.3x13.3 mm and it is made of a durable part of the pump (the Pump Base) that functions with a specific consumable (Reservoir-Patch). The pump is strapped to the body through its adhesive base. The insulin delivery is made thanks to a 5-mm cannula in stainless steel with a 90°... | PMC10449223 | ||
Continuous glucose monitoring | All patients were equipped with the Freestyle Libre sensor, a flash continuous glucose monitoring (CGM) system. This CGM requires scanning the sensor periodically for a continuous statement of glucose level. To obtain a complete visualization of glucose level on the last three months, the sensor was replaced every 14 d... | PMC10449223 | ||
Clinical data collections | cognitive impairment | EVENTS, SEVERE HYPOGLYCEMIA | Clinical data were recorded by the investigators on an electronic case report form (eCRF) at Visit 1 (inclusion visit), Visit 2 (1 month) and Visit 3 (3 months). Data generated by the insulin pump systems and the CGM were recorded throughout the study and extracted from web platforms available for the study. CGM wearin... | PMC10449223 |
Study outcomes | redness, pain | ADVERSE EVENTS | The primary study outcome was the glucose management indicator (GMI), an estimation of the laboratory A1C based on glucose parameters collected from CGM, on the last 10 weeks [An auto-questionnaire developed for the study was filled out by the patient at each visit to determine their satisfaction when using the insulin... | PMC10449223 |
Sample size | diabetes | DIABETES | The sample size was calculated based on an average GMI level obtained using the Omnipod pump of 7.8% (62 mmol/mol) according to the scientific committee. The non-inferiority between the study insulin pump devices was defined using the commonly accepted non-inferiority margin of 0.4% in similar study related to diabetes... | PMC10449223 |
Statistical analysis | diabetes | DIABETES MELLITUS TYPE 1, DIABETES | Statistical analyses were computed with SAS Version 9.4 (SAS Institute Inc., Cary, USA). Four analysis populations were defined for this study: the safety population which was composed of all patients having used the investigational device; the intent-to-treat (ITT) population composed of all included and randomized pa... | PMC10449223 |
Results | PMC10449223 | |||
Patients disposition and baseline characteristics | DYSFUNCTION | Overall, 100 patients were included and 93 were randomized and used the allocated study device (ITT Population): 45 patients in the Omnipod group and 48 patients in the A7+TouchCare group. Among them, 78 completed the study: 43 (95.6%) in the Omnipod group and 35 (72.9%) in the A7+Touchcare group. The main reasons for ... | PMC10449223 | |
Flow chart. | As shown in | PMC10449223 | ||
Characteristics of study participants at baseline (ITT population). | Data are n (%) or means±SD; ND: not determined;* Last laboratory A1C value of less than 1 month; No significant difference was observed between the two groups. | PMC10449223 | ||
Primary outcome | In the PP population, the GMI after 3 months of use (Visit 3) was similar in the Omnipod group (mean ± SD: 7.4±0.8%, 57 mmol/mol) and the A7+TouchCare group (7.3±0.8%, 56 mmol/mol). As summarized in | PMC10449223 | ||
Glucose management indicator (GMI): Non inferiority analysis at Visit 3 (Month 3). | * LSmeans (SEM); Difference Omnipod—A7+Touch Care; Missing values in the mITT population were replaced by the median value. | PMC10449223 | ||
Laboratory A1C | In the mITT population, there was no relevant variation in laboratory A1C which remained stable between inclusion (mean ± SD: 7.8±0.7%, 62 mmol/mol) and Visit 3 (7.7±0.7%, 61 mmol/mol) without statistically significant difference (p = 0.565) between the two groups. | PMC10449223 | ||
Freestyle Libre data | The mean (± SD) CGM wearing rate was not significantly different between the Omnipod group and the A7+TouchCare group at each visit: 91.3±11.4% vs. 90.0±13.6% (p = 0.625) at inclusion, 94.5±7.0% vs.91.6±11.8% (p = 0.200) at Visit 2, and 91.3±11.3% vs. 89.2±19.4% (p = 0.568) at Visit 3.Regardless of devices, the average... | PMC10449223 | ||
Continuous glycaemic parameters at each visit (ITTm population). | hypoglycemia | HYPOGLYCEMIA, EVENTS | Data are means ± SDThe mean number of hypoglycemia events per week, regardless of device, remained stable between inclusion (5.6±3.3) and Visit 3 (5.5±3.6) without difference between groups (p = 0.602, at Visit 3) ( | PMC10449223 |
Insulin dose administered | As shown in | PMC10449223 | ||
Insulin doses administered at each visit (mITT population). | Data are means±SD | PMC10449223 | ||
Patients’ satisfaction and preference | Results of the satisfaction questionnaire at Visit 2 and Visit 3 in the mITT population are provided in | PMC10449223 | ||
Satisfaction questionnaire at Visit 2 and Visit 3 (mITT population). | pain | Data are means±SDFor each question, the scale went from 1 (very unsatisfied) to 5 (very satisfied), except for Question 7 about pain for which 5 was painful and 1 was not painful at all.At Visit 3, patients randomized in the A7+TouchCare group had to indicate their preference for the insulin pump device on a scale from... | PMC10449223 | |
Device-related adverse events | ketonemia, Redness | EVENT, ADVERSE EVENT, KETONEMIA, REDNESS | Irritation/itching were reported in 26.7% and 27.1% of patients in the Omnipod and the A7+Touch Care, respectively. Redness were reported in 24.4% and 37.5% of patients in the Omnipod and the A7+Touch Care, respectively. As shown in One serious adverse event related to the A7+ Touch Care pump (3 episodes of ketonemia) ... | PMC10449223 |
Discussion | T1D, diabetes-related, diabetes | ADVERSE EVENTS, RECRUITMENT, ADVERSE EFFECTS, DYSFUNCTION, DIABETES | The A7+TouchCare is an insulin patch pump system recently available on the market in some European countries. The aim of the study was to determine the clinical performance and patients’ satisfaction of the A7+TouchCare compared to the Omnipod insulin patch pump, which was the only patch pump available in France to dat... | PMC10449223 |
Conclusion | diabetes | DIABETES | Both Omnipod and A7+TouchCare pumps showed similar performance to achieve glycemic control in patients with diabetes and the level of satisfaction was quite similar between groups. Although patients preferred the Omnipod as insulin management system and more specifically the patch delivery system (POD) of the Omnipod p... | PMC10449223 |
Supporting information | PMC10449223 | |||
Skin tolerability and adverse events between inclusion and Visit 3 (Safety population). | (DOCX)Click here for additional data file. | PMC10449223 | ||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.(PDF)Click here for additional data file.(PDF)Click here for additional data file.The authors would like to thank CRO Axonal-Biostatem (Castries, France) for study management, data management and statistics, and Thierry Radeau Consulting (Epinay-Sous-Senart, France) for medical ... | PMC10449223 | ||
Introduction | impulsive traits, SUDs, SUD, impulsivity | DISORDER, DISORDERS, RELAPSE | Around 35.6 million people between the ages of 15–64 suffer from substance use disorders (SUD) worldwide, corresponding to 0.7% of the global population [Besides the workforce developing a treatment for SUDs, offering effective treatments for this population remains challenging due to their harmful consumption, relapse... | PMC10629638 |
Methods | PMC10629638 | |||
Study design | This is a randomized clinical trial study, non-blinded, controlled, 1:1 with pre-post intervention comparison.This article was written according to SPIRIT Guidelines [ | PMC10629638 | ||
SPIRIT schedule presenting participant timeline. | PMC10629638 | |||
Study setting | SUDs | DISORDER | The participants were in a closed treatment for SUDs in a Therapeutic Community (TC), where people with SUDs stayed voluntarily or involuntarily to recover from the disorder in a controlled environment during a limited period [ | PMC10629638 |
Eligibility criteria | DISORDER | The Therapeutic Community is restricted to individuals with a substance use disorder referred to inpatient treatment by social services, health services or even by themselves. This study has followed the Helsinki Declaration. The participants were informed about the purpose of the study, potential benefits and risks, a... | PMC10629638 | |
CONSORT flow diagram. | ideation, psychotic disorders, neurological or psychiatric diseases | DISORDER | The inclusion criteria were that participants must: 1. Be 18 years old or older; 2. Have Portuguese as their first language; 3. Were receiving at the study period an inpatient treatment for substance use disorder of any kind; 4. Had been in the service for at least 15 days and therefore, reporting no drug consumption f... | PMC10629638 |
Interventions | PMC10629638 | |||
MBRP+TAU | The MBRP+TAU group was structured to happen in eight weekly meetings of two hours each. Therapists delivered MBRP to groups of 5–15 participants in each cohort. The protocol aims at becoming aware of triggers, habitual patterns, and automatic reactions that permeate the addictive process [ | PMC10629638 | ||
TAU | The TAU received the usual treatment delivered by the TC staff. It was structured and planned by the institution, follows the determinations of the Brazilian Federation of Therapeutic Communities (FEBRACT), and includes spirituality activities, 12 steps, relapse prevention, Singular Care Plan, and physical education, d... | PMC10629638 | ||
MBRP fidelity | MBRP sessions were recorded with a recorder without internet access and were evaluated by an independent reviser. We used an Excel sheet graded from 0 to 67 to evaluate the fidelity, which is the total number of protocol activities. The group activities were graded by the number of activities divided by the number of c... | PMC10629638 | ||
Sample size | impulsivity | SECONDARY | The sample size was calculated using G*Power Software version 3.1.9.4 considering a significance level of 5%, 80% observed power and 5% of effect size on the primary outcome (impulsivity) and secondary outcome (inhibitory control and decision making) for the intervention. Calculations were based on the primary outcome.... | PMC10629638 |
Recruitment | RECRUITMENT, RECRUITMENT, DISORDERS | The recruitment process happened from July 2018 to December 2019. This research was conducted in an inpatient treatment facility called therapeutic community located in Sao Paulo—Brazil that exclusively offers treatment for substance use disorders. Recruitment for study happened when the patients were already interned ... | PMC10629638 | |
Measures | Research assistants administered the questionnaires and the behavioral tests after receiving training from APGD. The participants answered it at the pre-intervention (two weeks before the intervention) and post-intervention (during the next two weeks, followed by the end of the intervention). Each approach was conducte... | PMC10629638 | ||
Self-report measures | impulsivity | POSITIVE | Sociodemographic data questionnaire: age, gender, monthly income, educational level, substance use, relationship status, and previous treatments for drug use.UPPS-P: A 20-item questionnaire assessing the impulsivity facets: Perseverance, Premeditation, Sensation Seeking, Positive Urgency, and Negative Urgency. Each ite... | PMC10629638 |
Behavioral tasks | Stroop Word Color Test: The test evaluates the inhibitory control ability ([Iowa Gambling Test (versions: A’B’C’D’ and K’L’M’N’): The computerized task which evaluates learning and decision-making in reward and punishment situations in uncertain conditions [ | PMC10629638 | ||
Procedure | The protocol had three phases: 1. Pre-intervention; 2. The intervention delivered to participants in treatment; and 3. Post-intervention, as represented in | PMC10629638 | ||
Fluxogram of the experimental design. | PMC10629638 | |||
Allocation | The randomization of the participants was conducted by the site (https//: | PMC10629638 | ||
Data management | PMC10629638 | |||
Data management | Data collection used paper-and-pen self-reported measures and a computer for behavioral tasks. All the participant forms were stored in numerical order and in a secure place at the Research Center for Health and Substance Use (NEPSIS). The electronic data from the behavioral tasks are stored in a computer with a passwo... | PMC10629638 |
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