Effects of a 12-week supervised resistance training program, combined with home-based physical activity, on physical fitness and quality of life in female breast cancer survivors: the EFICAN randomized controlled trial.

PURPOSE: This study assessed the effects of 12-week supervised resistance training combined with home-based physical activity on physical fitness, cancer-related fatigue, depressive symptoms, health-related quality of life (HRQoL), and life satisfaction in female breast cancer survivors. METHODS: A parallel-group, outcome assessor-blinded, randomized controlled trial included 60 female breast cancer survivors who had completed their core treatments within the previous 10 years. Through computer-generated simple randomization, participants were assigned to resistance training (RTG; two sessions/week for 12 weeks plus instructions to undertake ≥ 10,000 steps/d) or control (CG; ≥ 10,000 steps/d only). Outcomes were evaluated at baseline and week 12. Muscular strength was assessed with electromechanical dynamometry. A standardized full-body muscular strength score was the primary outcome. Secondary outcomes included cardiorespiratory fitness, shoulder mobility, cancer-related fatigue, depressive symptoms, HRQoL, and life satisfaction. RESULTS: Thirty-two participants were assigned to RTG (29 achieved ≥ 75% attendance) and 28 to CG (all completed the trial). Intention-to-treat analyses revealed that the standardized full-body muscular strength score increased significantly in the RTG compared to the CG (0.718; 95% CI 0.361-1.074, P < 0.001, Cohen's d = 1.04). This increase was consistent for the standardized scores of upper-body (0.727; 95% CI 0.294-1.160, P = 0.001, d = 0.87) and lower-body (0.709; 95% CI 0.324-1.094, P = 0.001, d = 0.96) strength. There was no effect on cardiorespiratory fitness, shoulder flexion, cancer-related fatigue, depressive symptoms, HRQoL, or life satisfaction. The sensitivity analyses confirmed these results. CONCLUSION: and implication for cancer survivors. In female breast cancer survivors who had completed their core treatments within the past 10 years, adding two weekly sessions of supervised resistance training to a prescription of home-based physical activity for 12 weeks produced a large increase in upper-, lower-, and full-body muscular strength, while other fitness components and patient-reported outcomes did not improve. TRIAL REGISTRATION NUMBER: ISRCTN14601208.

Mindfulness-Based Program for Anxiety and Depression Treatment in Healthcare Professionals: A Pilot Randomized Controlled Trial.

In primary health care, the work environment can cause high levels of anxiety and depression, triggering relevant expert and individual change. Mindfulness-Based Stress Reduction (MBSR) programs reduce signs of anxiety and depression. The purpose of this sub-analysis of the total project, was to equate the effectiveness of the standard MBSR curriculum with the abbreviated version in minimizing anxiety and depression. This randomized controlled clinical trial enrolled 112 mentors and resident specialists from Family and Community Medicine and Nurses (FCMN), distributed across six teaching units (TU) of the Spanish National Health System (SNHS). Experimental group participants received a MBRS training (abbreviated/standard). Depression and anxiety levels were measured with the Goldberg Anxiety and Depression Scale (GADS) at three different time periods during the analysis: before (pre-test) and after (post-test) participation, as well as 3 months after the completion of intervention. Taking into account the pre-test scores as the covariate, an adjusted analysis of covariance (ANCOVA) showed significant depletion in anxiety and depression in general (F (2.91) = 4.488; p = 0.014; η2 = 0.090) and depression in particular (F (2, 91) = 6.653; p = 0.002; η2 = 0.128 at the post-test visit, maintaining their effects for 3 months (F (2.79) = 3.031; p = 0.050; η2 = 0.071-F (2.79) = 2.874; p = 0.049; η2 = 0.068, respectively), which is associated with the use of a standard training program. The abbreviated training program did not have a significant effect on the level of anxiety and depression. The standard MBSR training program had a positive effect on anxiety and depression and promotes long-lasting effects in tutors and resident practitioners. New research is needed to demonstrate the effectiveness of abbreviated versions of training programs.

¿Es la fuerza de prensión manual un buen indicador de condición física y composición corporal en pacientes con cáncer de mama que han terminado los tratamientos centrales de la enfermedad? Estudio EFICAN / A força de preensão manual é um bom indicador da condição física e da composição corporal em doentes com cancro da mama que completaram os tratamentos centrais da doença? Estudo EFICAN / Is handgrip strength a good indicator of physical fitness and body composition in breast cancer patients who have completed their core treatments? The EFICAN study

Objetivo: evaluar la asociación entre la fuerza de prensión manual (FPM) y diversos parámetros de condición física y composición corporal en mujeres supervivientes de cáncer de mama.Método: se realizó un estudio transversal con los datos basales del ensayo clínico EFICAN (Ejercicio FÍsico para supervivientes de CÁNcer de mama). Participaron 60 mujeres supervivientes de cáncer de mama que habían terminado los tratamientos centrales de la enfermedad en los 10 años previos al comienzo del estudio, que no presentaban enfermedad pulmonar o cardiovascular, cáncer de mama metastásico, ni tenían prevista una intervención para reconstrucción mamaria en un plazo de 3 meses desde el comienzo del estudio. Se evaluó la fuerza de prensión manual mediante dinamometría manual, la fuerza muscular isométrica pico mediante dinamometría electromecánica funcional, el fitness cardiorrespiratorio (VO2máx) se estimó a través del Siconolfi step test, la amplitud de movimiento (ADM) en flexión de hombro mediante goniometría digital, y la composición corporal mediante bioimpedancia.Resultados: se observó una asociación positiva de la FPM con la masa muscular (r=0.423), y con la fuerza isométrica de miembro superior (r=0.523) e inferior (r=0.335), y una asociación negativa de la FPM con el porcentaje de grasa corporal (r=-0.405). Sin embargo, no se encontró asociación entre FPM y VO2máx ni ADM del hombro (P>0.05).Conclusiones: estos resultados sugieren que la FPM puede ser un buen indicador de fuerza muscular, así como de composición corporal en mujeres supervivientes de cáncer de mama. Futuros estudios prospectivos deberán evaluar el valor predictivo de la FPM en esta población. (AU)

Objectives: this study evaluated the association between handgrip strength (HGS) and various parameters of physical fitness and body composition in female breast cancer survivors.Methods: a cross-sectional study was conducted with the baseline data from the EFICAN (Ejercicio FÍsico para supervivientes de CÁNcer de mama) clinical trial. 60 female breast cancer survivors who had completed the core treatments of the disease in the 10 years prior to the study beginning, who didn’t have any cardiovascular or pulmonary disease, metastatic breast cancer or awaited breast cancer reconstruction in the following 3 months, participated. Handgrip strength was assessed using a digital dynamometer, peak isometric strength was determined using an electromechanical dynamometer, cardiorespiratory fitness (VO2máx) was estimated through the Siconolfi step test, shoulder flexion mobility was assessed through digital goniometry and body composition was determined using a bioelectrical impedance device.Results: positive associations between HGS and muscle mass (r=0.423), isometric upper-limb (r=0.523) and lower-limb (r=0.335) strength were found, and a negative association between HGS and fat mass percentage (r=-0.405) was also found. However, no associations between HGS and VO2máx or shoulder flexion mobility were found (P>0.05).Conclusions: these results suggest that HGS may be a good indicator of muscular strength and body composition in female breast cancer survivors. Future prospective studies are needed to assess the predictive value of HGS in this population. (AU)

Objetivo: avaliar a associação entre a força de preensão manual (FPM) e vários parâmetros de condição física e composição corporal em mulheres sobreviventes de cancro da mama.Método: foi realizado um estudo transversal utilizando dados de base do ensaio clínico EFICAN (Physical Exercise for Breast Cancer Survivors). Participaram sessenta mulheres sobreviventes de cancro da mama que tinham concluído os tratamentos centrais da doença nos 10 anos anteriores ao início do estudo, que não tinham doenças pulmonares ou cardiovasculares, cancro da mama metastásico, ou que não estavam programadas para se submeterem à reconstrução da mama nos 3 meses seguintes ao início do estudo. A força de preensão manual foi avaliada por dinamometria manual, o pico de força muscular isométrica por meio de dinamometria electromecânica funcional, a capacidade cardiorrespiratória (VO2máx) foi estimada pelo Siconolfi step test, a amplitude de movimento (ADM) em flexão do ombro por meio de goniometria digital, e a composição corporal por bioimpedância.Resultados: observámos uma associação positiva de FPM com massa muscular (r=0,423), e com força isométrica de membro superior (r=0,523) e membro inferior (r=0,335), e uma associação negativa de FPM com percentagem de gordura corporal (r=-0,405). Contudo, não foi encontrada qualquer associação entre FPM e VO2max ou ADM de ombro (P>0.05).Conclusões: estes resultados sugerem que a FPM pode ser um bom indicador da força muscular, bem como da composição corporal das mulheres sobreviventes de cancro da mama. Os futuros estudos prospectivos devem avaliar o valor preditivo do FPM nesta população. (AU)

Effects of a 12-week resistance and aerobic exercise program on muscular strength and quality of life in breast cancer survivors: Study protocol for the EFICAN randomized controlled trial.

BACKGROUND: The number of people living with the side effects of breast cancer treatment (eg, loss of muscular mass and muscular strength, upper-limb mobility and disability, lymphedema, cardiac toxicity, and reduced quality of life) is increasing yearly. These consequences can be improved through exercise, specially combining resistance and aerobic training. Previous exercise trials have not been consistent in applying training principles and standardized reporting, and this partly explains the variability in obtained results. The aim of this study is to assess the effect of a 12-week supervised resistance exercise program combined with home-based aerobic exercise, compared with home-based aerobic exercise only, on muscular strength and several aspects of health-related quality of life in breast cancer survivors. To maximize transparency, replicability, and clinical applicability, the intervention is described following the consensus on exercise reporting template. METHODS: This study is a parallel-group randomized controlled trial in which 60 female breast cancer survivors, who have completed central treatments of the disease in the last 5 years, will be randomly assigned to either an experimental group that will perform a total of 24 progressive resistance training sessions for 12 weeks (ie, 2 weeks of individual training and 10 weeks of micro-group training) and will be requested to undertake 10,000 steps/d, or a control group that will be requested to undertake 10,000 steps/d, only. Outcomes will be evaluated at baseline and at week 12. Primary outcome measure is peak isometric muscular strength of the lower- and upper-body, assessed with several exercises through an electromechanical dynamometer. Secondary outcomes include cardiorespiratory fitness, upper-joint mobility and disability, health-related quality of life, cancer-related fatigue, depression, life satisfaction, and presence of lymphedema. DISCUSSION: This study aims to investigate the extent to which a 12-week supervised and progressive resistance exercise program, in addition to home-based aerobic physical activity, might improve muscular strength and health-related quality of life in breast cancer survivors. The comprehensive description of the intervention will likely contribute to enhancing exercise prescription in this population. TRIAL REGISTRATION NUMBER: ISRCTN14601208.

Controlled clinical trial comparing the effectiveness of a mindfulness and self-compassion 4-session programme versus an 8-session programme to reduce work stress and burnout in family and community medicine physicians and nurses: MINDUUDD study protocol.

BACKGROUND: Health personnel are susceptible to high levels of work stress and burnout due to the psychological and emotional demands of their work, as well as to other aspects related to the organisation of that work. This paper describes the rationale and design of the MINDUUDD study, the aim of which is to evaluate the effectiveness of a mindfulness and self-compassion 4-session programme versus the standard 8-session programme to reduce work stress and burnout in Family and Community Medicine and Nursing tutors and residents. METHODS: The MINDUDD study is a multicentre cluster randomised controlled trial with three parallel arms. Six Teaching Units will be randomised to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4) Control group (CG). At least 132 subjects will participate (66 tutors/66 residents), 44 in the EG8, 44 in the EG4, and 44 in the CG. Interventions will be based on the Mindfulness-Based Stress Reduction (MBSR) program, including some self-compassion practices of the Mindful Self-Compassion (MSC) programme. The EG8 intervention will be implemented during 8 weekly face-to-face sessions of 2.5 h each, while the EG4 intervention will consist of 4 sessions of 2.5 h each. The participants will have to practice at home for 30 min/day in the EG8 and 15 min/day in the EG4. The Five Facet Mindfulness Questionnaire (FFMQ), Self-Compassion Scale (SCS), Perceived Stress Questionnaire (PSQ), Maslach Burnout Inventory (MBI), Jefferson Scale of Physician Empathy (JSPE), and Goldberg Anxiety-Depression Scale (GADS) will be administered. Measurements will be taken at baseline, at the end of the programs, and at three months after completion. The effect of the interventions will be evaluated by bivariate and multivariate analyses (Multiple Linear Regression). DISCUSSION: If the abbreviated mindfulness programme is at least as effective as the standard program, its incorporation into the curriculum and training plans will be easier and more appropriate. It will also be more easily applied and accepted by primary care professionals because of the reduced resources and means required for its implementation, and it may also extend beyond care settings to academic and teaching environments as well. TRIAL REGISTRATION: The study has been registered at ClinicalTrials.gov ( NCT03629457 ; date of registration: 13.08.2018).