- Four visits will be scheduled at diagnosis, after treatments, and 12 and 18 months after diagnosis. - The same procedure will be followed for each visit. - Each session will be composed of anthropometric data collection, a semi-structured interview, cognitive tests, postural control tests, neuromuscular fatigability tests and a cardiorespiratory fitness test. - Clinical and biological data will be collected during medical follow-ups. - Two hundred women newly diagnosed with breast can- cer by an oncologist and satisfying inclusion and exclu- sion criteria (Table 2) will be informed of the study protocol. - If interested, patients will receive an informa- tion letter from their oncologist and will be given the opportunity to ask any questions pertaining to it. - Four visits will be scheduled (the study timeline is presented in Fig. - Detailed patient assessments will be performed before treatment begins (visit 1: diagnosis);. - This study has been approved by the French ethics committee of human research CPP SUD EST VI (IDRCB: 2019-A02525–52) and will be per- formed according to the Declaration of Helsinki. - In order to longitudinally assess the evolution of biopsy- chosocial dimensions of CRF, the same procedure will be followed for each visit. - Each session will last 1.5 h and will be composed of anthropometric data collection, a semi-structured interview, cognitive tests, postural con- trol tests, neuromuscular fatigability tests and a cardiore- spiratory fitness test. - In addition, partici- pants will be asked to wear an actigraphy device (re- ceived by mail one week prior to each experimental. - Body height, body mass, lower limb fat mass (using impedancemetry) and calf circumference (CC) will be measured. - CC will be recorded to assess the dominant lower limb volume using the truncated cones technique [39] by dividing the lower limb volume into a series of segments. - Then, the lower limb volume will be used to normalize maximal strength of participants. - To investigate the social dimension of CRF, a semi- structured interview will be conducted (duration ~ 30 min). - Demographic (e.g., age, gender, socio-professional category, residence area, income) and sociability (e.g., family, friendly, professional) will be addressed. - The interview will be introduced by an open question on a typical week to then develop the sociability. - The entire interview will be audio recorded, fully transcribed and then will be the subject of a lexicographical treatment for rating quantity and intensity of sociability (on a scale from − 5 to 5). - Lastly, family, friendships, professional sociabilities and income will be considered in the SEM analysis.. - The Montreal Cognitive Assessment (MoCA), the Trail Making Test (TMT) and the Stroop test will be completed by participants to assess cognitive functions. - For example, the participants will be asked to connect numbers and letters in a defined sequence, count backwards from 100 by in- crements of 7, draw different figures and perform word as- sociations. - Time needed to complete each part and number of mistakes will be recorded to assess performance. - For each part, participants will be advised to name the ink color for each word, regardless of the semantic content, as quickly and accurately as possible. - The TMT and the Stroop test will be implemented on Inquisit software (Millisecond Software, LCC, Seattle, USA). - will be considered.. - Participants will be asked to stand up barefoot, as still as possible, during 60 s on a pressure distribution measure- ment platform (FDM-S, zebris Medical GmbH, Isny, Germany). - Feet position will be standardized using markings to keep both heels spaced apart by 10 cm and an angle of 15° between both feet. - Participants will be advised to keep arms alongside the body during record- ing. - Four conditions composed of two trials of a simple task and two trials of a dual task (counting backwards by 2 from a number close to 100) with eyes open or closed will be counterbalanced and interspersed with a 2 min rest period. - In eyes open conditions, participants will be asked to stare at a visual marker placed 2 m in front at eye level. - For the dual task, participants will be asked to count as fast as possible whilst remaining as immobile as possible. - The numbers of answers and errors will be re- corded. - Temporal analysis will be performed in order to investigate anterior-posterior and medial-lateral center of pressure (COP) distance, mean and maximal COP velocities and 95% confidence ellipse area. - 1.5 Hz frequency bands) will be com- puted. - Firstly, optimal electrical stimulation intensity will be deter- mined to set the supramaximal intensity used during the subsequent neuromuscular assessments by pro- gressively increasing the current (from 20-mA to 200-. - The last intensity obtained will be further increased by 20% to ensure stimulus supramaximality. - All elec- trical stimulations will be delivered with a constant current (Digitimer DS7A-H, Hertfordshire, UK) using square-wave stimuli of 200 μs duration with a max- imal voltage of 400-V and via rectangular self- adhesive electrodes (5 × 10 cm, Compex). - The cathode will be placed over the gastrocnemii. - if the difference between these MVCs is superior to 5%, a third one will be performed). - The higher peak force produced will be considered as the MVC in non-fatiguing conditions. - Next, pre-fatigue neuromuscular functions will be assessed on a third MVC, using a 100-Hz doublet during the force plat- eau and a stimulation sequence on the relaxed mus- cles beginning 2 s after the end of contraction: a 100- Hz doublet, a 10-Hz doublet and a simple stimula- tion, interspersed by 3 s. - The fatiguing exercise will be composed of 62 isometric MVC in ankle plantar flexors with the dominant leg (Fig. - duty cycle will be ensured using a metronome with visual and sound signals. - The post-fatigue neuromuscular functions will be assessed on the last MVC of the fatiguing exercise (62nd) with the same stimulation procedure as in pre-fatigue condition. - Peak force occurring during each 4-s MVC set will be recorded and the force-time relationship asymptote (F A . - expressed in percentage of the MVC in non- fatiguing conditions) will be used to represent a neuromuscular fatigability threshold, above which fat- igability drastically sets in . - will be considered in the SEM.. - Throughout the test, participants will be encouraged to maintain a constant cadence (approximately 60 rpm) and heart rate (HR) will be recorded with a heart rate monitor (HRM-Dual, Garmin, Olathe, USA). - Every 2 min [Lactate] b will be measured as previ- ously described and then intensity will be increased by 10 W steps. - Exercise will be stopped as soon as i) [Lactate] b ≥ 4 mmol. - Participants will be able to interrupt the exercise when they wish to do so, par- ticularly in the case of nausea, chest pain or dyspnea.. - This test will be used to determine the physiological and biomechanical parameters (i.e., HR, power output associ- ated with the first lactate threshold (LT1. - Power output at LT1 (W) will be considered in the SEM.. - As experimental sessions will accompany medical follow-ups, clinical and biological data will be also re- corded. - Cancer stage and details related to treatments (e.g., type, duration and dose) will be recorded in a med- ical file by their oncologist. - Venous blood samples will be collected by medical staff. - Plasma will be obtained after a 10 min centrifugation at 4 °C, then divided into. - Following assays will be performed on plasma for the assessment of inflammation (IL-6, TNFɑ, IL-8, IL-1β). - The surface of the muscular tissues will be se- lected according to the CT Hounsfield unit and normal- ized to stature in order to calculate the lumbar skeletal muscle index (LSMI). - 38.5cm 2 / m 2 ) will be used to characterize sarcopenia [49]. - and IL-6, IL-1β, TNFɑ (pg/mL) concentrations will be considered in the SEM.. - Participants will be asked to complete questionnaires, alone in quiet conditions, and bring it back the day of the experimental session. - The subsequent instructions will be provided: “Please answer all questions yourself by circling the number that best applies to you. - The EORTC QLQ-C30 Fatigue scale score (FA item) will be used to assess the general degree of CRF (ranging from 0 to 100. - EORTC QLQ-FA12 subscales will be used to as- sess physical, cognitive and emotional dimensions of CRF [51]. - and anxiety and depression scales (/21) will be considered.. - One week prior to each experimental session, partici- pants will be asked to wear a portable device (eTact®, BodyCap, Caen, France) containing a tri-axial acceler- ometers enabling to record every acceleration from the body (sampling frequency: 25 Hz, measurement range:. - They will be ad- vised to wear the device continuously for 7 days (days and nights) regardless of daily activities. - Sleep character- istics will be obtained using the eTact® Analysis software (BodyCap, Caen, France), which assess the individual sleep quality based on the actigraphy data collected over selected periods. - Considered sleep parameter will be sleep time (i.e, duration of effective sleep period) and sleep efficiency (i.e., percentage of time spent sleeping during the rest period). - From the software, total activity duration during wake period will be calculated as the ac- cumulated time in each activity intensity band (i.e., low,. - In addition, participants will be asked to complete a sleep diary (including estimated sleep onset and offset hour) during the actigraphy mea- surements. - Hypotheses will be addressed by constructing a biopsy- chosocial model of the relationships among biological, physical, emotional, cognitive and social dimensions of CRF using multilevel SEM. - The model will be tested with the maximum likelihood method using Lavaan R package for SEM [57].. - A primary cross-sectional analysis will be completed using data collected at each visit, and then subsequently by using the longitudinal data set. - All patients with localized breast cancer will be in- cluded, inherently incorporating various conditions of cancer stages and treatment. - Written informed consent will be obtained from each partici- pant prior their inclusion in the study.. - https://doi.org/10.1007/s . - https://doi.org/10.1007/s x.. - https://doi.org/10.1002/. - https://doi.. - https://doi.org/10.1038/. - https://doi.org/10.1200/JCO . - https://doi.org/10.1093/annonc/. - https://doi.org/10.1200/. - doi.org/10.1007/s . - https://doi.org . - https://doi.org/10.1186/s y.. - https://doi.org/10.1023/A . - doi.org/10.1111/j x.. - https://doi.org X310200.. - https://doi.org/10.1046/j x.. - https://doi.org/10.1152/japplphysiol . - https://doi.org/10.1249/MSS . - https://doi.org/10.1016/S . - https://doi.org/10.1186/s . - https://doi.org/10.1111/j tb09716.x.. - https://doi.org/10.1207/s15327906mbr2502_4.. - https://doi.org/10.1007/
Xem thử không khả dụng, vui lòng xem tại trang nguồn hoặc xem
Tóm tắt