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      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

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          Abstract

          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.

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          Most cited references58

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          Exercise interventions on health-related quality of life for cancer survivors.

          Cancer survivors experience numerous disease and treatment-related adverse outcomes and poorer health-related quality of life (HRQoL). Exercise interventions are hypothesized to alleviate these adverse outcomes. HRQoL and its domains are important measures for cancer survivorship. To evaluate the effectiveness of exercise on overall HRQoL and HRQoL domains among adult post-treatment cancer survivors. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, PEDRO, LILACS, SIGLE, SportDiscus, OTSeeker, and Sociological Abstracts from inception to October 2011 with no language or date restrictions. We also searched citations through Web of Science and Scopus, PubMed's related article feature, and several websites. We reviewed reference lists of included trials and other reviews in the field. We included all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing exercise interventions with usual care or other nonexercise intervention to assess overall HRQoL or at least one HRQoL domain in adults. Included trials tested exercise interventions that were initiated after completion of active cancer treatment. We excluded trials including people who were terminally ill, or receiving hospice care, or both, and where the majority of trial participants were undergoing active treatment for either the primary or recurrent cancer. Five paired review authors independently extracted information on characteristics of included trials, data on effects of the intervention, and assessed risk of bias based on predefined criteria. Where possible, meta-analyses results were performed for HRQoL and HRQoL domains for the reported difference between baseline values and follow-up values using standardized mean differences (SMD) and a random-effects model by length of follow-up. We also reported the SMDs between mean follow-up values of exercise and control group. Because investigators used many different HRQoL and HRQoL domain instruments and often more than one for the same domain, we selected the more commonly used instrument to include in the SMD meta-analyses. We also report the mean difference for each type of instrument separately. We included 40 trials with 3694 participants randomized to an exercise (n = 1927) or comparison (n = 1764) group. Cancer diagnoses in study participants included breast, colorectal, head and neck, lymphoma, and other. Thirty trials were conducted among participants who had completed active treatment for their primary or recurrent cancer and 10 trials included participants both during and post cancer treatment. Mode of the exercise intervention included strength training, resistance training, walking, cycling, yoga, Qigong, or Tai Chi. HRQoL and its domains were measured using a wide range of measures.The results suggested that exercise compared with control has a positive impact on HRQoL and certain HRQoL domains. Exercise resulted in improvement in: global HRQoL at 12 weeks' (SMD 0.48; 95% confidence interval (CI) 0.16 to 0.81) and 6 months' (0.46; 95% CI 0.09 to 0.84) follow-up, breast cancer concerns between 12 weeks' and 6 months' follow-up (SMD 0.99; 95% CI 0.41 to 1.57), body image/self-esteem when assessed using the Rosenberg Self-Esteem scale at 12 weeks (MD 4.50; 95% CI 3.40 to 5.60) and between 12 weeks' and 6 months' (mean difference (MD) 2.70; 95% CI 0.73 to 4.67) follow-up, emotional well-being at 12 weeks' follow-up (SMD 0.33; 95% CI 0.05 to 0.61), sexuality at 6 months' follow-up (SMD 0.40; 95% CI 0.11 to 0.68), sleep disturbance when comparing follow-up values by comparison group at 12 weeks' follow-up (SMD -0.46; 95% CI -0.72 to -0.20), and social functioning at 12 weeks' (SMD 0.45; 95% CI 0.02 to 0.87) and 6 months' (SMD 0.49; 95% CI 0.11 to 0.87) follow-up. Further, exercise interventions resulted in decreased anxiety at 12 weeks' follow-up (SMD -0.26; 95% CI -0.07 to -0.44), fatigue at 12 weeks' (SMD -0.82; 95% CI -1.50 to -0.14) and between 12 weeks' and 6 months' (SMD -0.42; 95% CI -0.02 to -0.83) follow-up, and pain at 12 weeks' follow-up (SMD -0.29; 95% CI -0.55 to -0.04) when comparing follow-up values by comparison group.Positive trends and impact of exercise intervention existed for depression and body image (when analyzing combined instruments); however, because few studies measured these outcomes the robustness of findings is uncertain.No conclusions can be drawn regarding the effects of exercise interventions on HRQoL domains of cognitive function, physical functioning, general health perspective, role function, and spirituality.Results of the review need to be interpreted cautiously owing to the risk of bias. All the trials reviewed were at high risk for performance bias. In addition, the majority of trials were at high risk for detection, attrition, and selection bias. This systematic review indicates that exercise may have beneficial effects on HRQoL and certain HRQoL domains including cancer-specific concerns (e.g. breast cancer), body image/self-esteem, emotional well-being, sexuality, sleep disturbance, social functioning, anxiety, fatigue, and pain at varying follow-up periods. The positive results must be interpreted cautiously due to the heterogeneity of exercise programs tested and measures used to assess HRQoL and HRQoL domains, and the risk of bias in many trials. Further research is required to investigate how to sustain positive effects of exercise over time and to determine essential attributes of exercise (mode, intensity, frequency, duration, timing) by cancer type and cancer treatment for optimal effects on HRQoL and its domains.
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            Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity.

            The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure was developed to evaluate disability and symptoms in single or multiple disorders of the upper limb at one point or at many points in time. The purpose of this study was to evaluate the reliability, validity, and responsiveness of the DASH in a group of diverse patients and to compare the results with those obtained with joint-specific measures. Two hundred patients with either wrist/hand or shoulder problems were evaluated by use of questionnaires before treatment, and 172 (86%) were re-evaluated 12 weeks after treatment. Eighty-six patients also completed a test-retest questionnaire three to five days after the initial (baseline) evaluation. The questionnaire package included the DASH, the Brigham (carpal tunnel) questionnaire, the SPADI (Shoulder Pain and Disability Index), and other markers of pain and function. Correlations or t-tests between the DASH and the other measures were used to assess construct validity. Test-retest reliability was assessed using the intraclass correlation coefficient and other summary statistics. Responsiveness was described using standardized response means, receiver operating characteristics curves, and correlations between change in DASH score and change in scores of other measures. Standard response means were used to compare DASH responsiveness with that of the Brigham questionnaire and the SPADI in each region. The DASH was found to correlate with other measures (r > 0.69) and to discriminate well, for example, between patients who were working and those who were not (p<0.0001). Test-retest reliability (ICC = 0.96) exceeded guidelines. The responsiveness of the DASH (to self-rated or expected change) was comparable with or better than that of the joint-specific measures in the whole group and in each region. Evidence was provided of the validity, test-retest reliability, and responsiveness of the DASH. This study also demonstrated that the DASH had validity and responsiveness in both proximal and distal disorders, confirming its usefulness across the whole extremity.
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              Concurrent validation of the OMNI perceived exertion scale for resistance exercise.

              The criterion variables were total weight lifted (Wttot ) determined separately for women and men during BC and KE, and blood lactic acid concentration ([Hla]) determined for a combined female ( N = 10) and male ( N = 10) subset during BC. Subjects performed three separate sets of 4, 8, and 12 repetitions for BC and KE at 65% one-repetition maximum. Rating of perceived exertion for the active muscles (RPE-AM) was measured during the mid and final repetition and RPE for the overall body (RPE-O) during the final repetition. : For both female and male groups across the three sets: (a) RPE-AM ranged from 3.6 to 8.2 for BC and 5.1 to 9.6 for KE and (b) RPE-O ranged from 2.4 to 6.7 for BC and 4.2 to 7.6 for KE. Positive linear regressions ranged from r = 0.79 to 0.91 ( P < 0.01) between Wttot and RPE-AM (mid), RPE-AM (final), and RPE-O for both BC and KE in both sex groupings. A positive ( P < 0.01) linear regression was found between [Hla] and RPE-AM (final) (r = 0.87) during BC. RPE did not differ between women and men at any measurement point within each set for BC and KE. RPE-AM (final) was greater ( P < 0.01) than RPE-O in the three sets of BC and KE. Findings provided concurrent validation of the OMNI-RES to measure RPE for the active muscle and overall body in young recreationally trained female and male weight lifters performing upper- and lower-body resistance exercise.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                November 2019
                01 November 2019
                : 98
                : 44
                : e17625
                Affiliations
                [a ]Department of Education, Faculty of Education Sciences
                [b ]SPORT Research Group (CTS-1024), CERNEP Research Centre, University of Almería
                [c ]Hospital Universitario Torrecárdenas, Servicio de Radiodiagnóstico, Unidad de Mama, Almería, Spain
                [d ]Servicio Andaluz de Salud, Unidad de Gestión Clínica Almería Periferia
                [e ]Servicio Andaluz de Salud, Unidad de Gestión Clínica Ciudad Jardín
                [f ]Servicio Andaluz de Salud, Unidad de Gestión Clínica Mediterráneo-Torrecárdenas, Distrito Sanitario
                [g ]Area of Statistics and Operative Research, Department of Mathematics, Faculty of Sciences, University of Almería, Almería, Spain.
                Author notes
                []Correspondence: Alberto Soriano-Maldonado, SPORT Research Group (CTS-1024), Department of Education, Faculty of Education Sciences, University of Almería, Carretera de Sacramento, s/n, 04120, La Cañada, Almería, Spain (e-mail: asoriano@ 123456ual.es ).
                Article
                MD-D-19-07502 17625
                10.1097/MD.0000000000017625
                6946307
                31689771
                8f677dbf-7faa-4cf9-ba80-6c7521c52c67
                Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 24 September 2019
                : 24 September 2019
                Categories
                7000
                Research Article
                Study Protocol Clinical Trial
                Custom metadata
                TRUE

                breast cancer,cancer-related fatigue,exercise,health-related quality of life,muscular strength,resistance training

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