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

Alberto Soriano-Maldonado, Álvaro Carrera-Ruiz, David M Díez-Fernández, Alba Esteban-Simón, Mercedes Maldonado-Quesada, Nuria Moreno-Poza, María Del Mar García-Martínez, Celia Alcaraz-García, Rosa Vázquez-Sousa, Herminia Moreno-Martos, Antonio Toro-de-Federico, Nur Hachem-Salas, Eva Artés-Rodríguez, Manuel A Rodríguez-Pérez, Antonio J Casimiro-Andújar, Alberto Soriano-Maldonado, Álvaro Carrera-Ruiz, David M Díez-Fernández, Alba Esteban-Simón, Mercedes Maldonado-Quesada, Nuria Moreno-Poza, María Del Mar García-Martínez, Celia Alcaraz-García, Rosa Vázquez-Sousa, Herminia Moreno-Martos, Antonio Toro-de-Federico, Nur Hachem-Salas, Eva Artés-Rodríguez, Manuel A Rodríguez-Pérez, Antonio J Casimiro-Andújar

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.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Assessment muscular strength (A) mid-thigh isometric pull test and upper-body muscular strength, (B) unilateral isometric knee extension in closed kinetic chain at 90°, (C) bilateral isometric seated bench press, (D) unilateral isometric seated bench press, (E) bilateral isometric seated row, (F) unilateral isometric seated row.

References

    1. Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68:394–424.
    1. Sociedad Española de Oncología Médica (SEOM). Las Cifras del Cáncer en España. Madrid; 2019
    1. Europa Press. Almería registra cada año cerca de 500 nuevos casos de cáncer de mama. Europa Press. Available at: . Published 2018. [Accessed on September 22, 2019]
    1. Canadian Cancer Society's Advisory Committee on Cancer. Canadian Cancer Statistics. Toronto, ON; 2016.
    1. Carioli G, Malvezzi M, Rodriguez T, et al. Trends and predictions to 2020 in breast cancer mortality in Europe. Breast 2017;36:89–95.
    1. Rockson SG. Lymphedema after breast cancer treatment. N Engl J Med 2018;379:1937–44.
    1. Yeboa DN, Evans SB. Contemporary breast radiotherapy and cardiac toxicity. Semin Radiat Oncol 2016;26:71–8.
    1. Spiegel D, Giese-Davis J. Depression and cancer: mechanisms and disease progression. Biol Psychiatry 2003;54:269–82.
    1. Stasi R, Abriani L, Beccaglia P, et al. Cancer-related fatigue. Cancer 2003;98:1786–801.
    1. Barone I, Giordano C, Bonofiglio D, et al. The weight of obesity in breast cancer progression and metastasis: clinical and molecular perspectives. Semin Cancer Biol 2019;Epub ahead of print.
    1. Hidding JT, Beurskens CHG, van der Wees PJ, et al. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One 2014;9:e96748.
    1. Hayes SC, Johansson K, Stout NL, et al. Upper-body morbidity after breast cancer. Cancer 2012;118:2237–49.
    1. Mols F, Vingerhoets AJJM, Coebergh JW, et al. Quality of life among long-term breast cancer survivors: a systematic review. Eur J Cancer 2005;41:2613–9.
    1. Runowicz CD, Leach CR, Henry NL, et al. American Cancer Society/American Society of Clinical Oncology Breast Cancer survivorship care guideline. CA Cancer J Clin 2016;66:43–73.
    1. Klassen O, Schmidt ME, Ulrich CM, et al. Muscle strength in breast cancer patients receiving different treatment regimes. J Cachexia Sarcopenia Muscle 2017;8:305–16.
    1. Peel AB, Thomas SM, Dittus K, et al. Cardiorespiratory fitness in breast cancer patients: a call for normative values. J Am Heart Assoc 2014;3:e000432.
    1. Jones LW, Courneya KS, Mackey JR, et al. Cardiopulmonary function and age-related decline across the breast cancer survivorship continuum. J Clin Oncol 2012;30:2530–7.
    1. Rock CL, Doyle C, Demark-Wahnefried W, et al. Nutrition and physical activity guidelines for cancer survivors. CA Cancer J Clin 2012;62:242–74.
    1. Mishra SI, Scherer RW, Geigle PM, et al. Exercise interventions on health-related quality of life for cancer survivors. Cochrane Database Syst Rev 2012;CD007566.
    1. Meneses-Echávez JF, González-Jiménez E, Ramírez-Vélez R. Effects of supervised exercise on cancer-related fatigue in breast cancer survivors: a systematic review and meta-analysis. BMC Cancer 2015;15:77.
    1. Zeng Y, Huang M, Cheng ASK, et al. Meta-analysis of the effects of exercise intervention on quality of life in breast cancer survivors. Breast Cancer 2014;21:262–74.
    1. Bedillion MF, Ansell EB, Thomas GA. Cancer treatment effects on cognition and depression: the moderating role of physical activity. Breast 2019;44:73–80.
    1. Strasser B, Steindorf K, Wiskemann J, et al. Impact of resistance training in cancer survivors: a meta-analysis. Med Sci Sport Exerc 2013;45:2080–90.
    1. Hasenoehrl T, Keilani M, Palma S, et al. Resistance exercise and breast cancer related lymphedema–a systematic review update. Disabil Rehabil 2019;1–0. Epub ahead of print.
    1. Paramanandam VS, Roberts D. Weight training is not harmful for women with breast cancer-related lymphoedema: a systematic review. J Physiother 2014;60:136–43.
    1. Nelson NL. Breast cancer–related lymphedema and resistance exercise. J Strength Cond Res 2016;30:2656–65.
    1. Schmitz KH, Ahmed RL, Troxel AB, et al. Weight lifting for women at risk for breast cancer–related lymphedema. JAMA 2010;304:2699.
    1. Hardee JP, Porter RR, Sui X, et al. The effect of resistance exercise on all-cause mortality in cancer survivors. Mayo Clin Proc 2014;89:1108–15.
    1. Neil-Sztramko SE, Winters-Stone KM, Bland KA, et al. Updated systematic review of exercise studies in breast cancer survivors: attention to the principles of exercise training. Br J Sports Med 2019;53:504–12.
    1. Slade SC, Keating JL. Exercise prescription: a case for standardised reporting. Br J Sports Med 2012;46:1110–3.
    1. Fairman CM, Zourdos MC, Helms ER, et al. A scientific rationale to improve resistance training prescription in exercise oncology. Sport Med 2017;47:1457–65.
    1. Furmaniak AC, Menig M, Markes MH. Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database Syst Rev 2016;9:CD005001.
    1. McNeely ML, Campbell K, Ospina M, et al. Exercise interventions for upper-limb dysfunction due to breast cancer treatment. Cochrane Database Syst Rev 2010;6: CD005211.
    1. Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev 2012;11: CD006145.
    1. Speck RM, Courneya KS, Mâsse LC, et al. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv 2010;4:87–100.
    1. Zeng J, Wu J, Tang C, et al. Effects of exercise during or postchemotherapy in cancer patients: a systematic review and meta-analysis. Worldviews Evid Based Nurs 2019;16:92–101.
    1. Slade SC, Dionne CE, Underwood M, et al. Consensus on exercise reporting template (CERT): explanation and elaboration statement. Br J Sports Med 2016;50:1428–37.
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200.
    1. Tudor-Locke C, Bassett DR. How many steps/day are enough? Sport Med 2004;34:1–8.
    1. Michigan, American College of Sports Medicine. Starting a Walking Program. 2011.
    1. Robertson RJ, Goss FL, Rutkowski J, et al. Concurrent validation of the OMNI perceived exertion scale for resistance exercise. Med Sci Sport Exerc 2003;35:333–41.
    1. American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sport Exerc 2009;41:687–708.
    1. Fragala MS, Cadore EL, Dorgo S, et al. Resistance training for older adults: position statement from the national strength and conditioning association. J Strength Cond Res 2019;33:2019–52.
    1. Ferrari R, Kruel LFM, Cadore EL, et al. Efficiency of twice weekly concurrent training in trained elderly men. Exp Gerontol 2013;48:1236–42.
    1. Ferrari R, Fuchs SC, Kruel LFM, et al. Effects of different concurrent resistance and aerobic training frequencies on muscle power and muscle quality in trained elderly men: a randomized clinical trial. Aging Dis 2016;7:697–704.
    1. Izquierdo M, Ibañez J, González-Badillo JJ, et al. Differential effects of strength training leading to failure versus not to failure on hormonal responses, strength, and muscle power gains. J Appl Physiol 2006;100:1647–56.
    1. Sanborn K, Boros R, Hruby J, et al. Short-term performance effects of weight training with multiple sets not to failure vs. a single set to failure in women. J Strength Cond Res 2000;14:328–31.
    1. González-Badillo J, Rodríguez-Rosell D, Sánchez-Medina L, et al. Short-term recovery following resistance exercise leading or not to failure. Int J Sports Med 2015;37:295–304.
    1. Pareja-Blanco F, Rodríguez-Rosell D, Sánchez-Medina L, et al. Acute and delayed response to resistance exercise leading or not leading to muscle failure. Clin Physiol Funct Imaging 2017;37:630–9.
    1. González-Badillo JJ, Rodríguez-Rosell D, Sánchez-Medina L, et al. Maximal intended velocity training induces greater gains in bench press performance than deliberately slower half-velocity training. Eur J Sport Sci 2014;14:772–81.
    1. Villa-González E, Barranco-Ruiz Y, Rodríguez-Pérez MA, et al. Supervised exercise following bariatric surgery in morbid obese adults: CERT-based exercise study protocol of the EFIBAR randomised controlled trial. BMC Surg 2019;19:127.
    1. Jerez-Mayorga D, Chirosa Ríos LJ, Reyes A, et al. Muscle quality index and isometric strength in older adults with hip osteoarthritis. PeerJ 2019;7:e7471.
    1. Chamorro C, la Fuente C, Rubio J, et al. Absolute reliability and concurrent validity of a novel electromechanical pulley dynamometer for measuring shoulder rotation isometric strength in asymptomatic subjects. Study conducted at Pontificia Universidad Católica, Santiago, Chile. J Pak Med Assoc 2019;69:1000–5.
    1. Cerda Vega E, Jerez-Mayorga D, Machado Payer R, et al. Validity and reliability of evaluating hip abductor strength using different normalization methods in a functional electromechanical device. PLoS One 2018;13:e0202248.
    1. Siconolfi SF, Garber CE, Lasater TM, et al. A simple, valid step test for estimating maximal oxygen uptake in epidemiologic studies. Am J Epidemiol 1985;121:382–90.
    1. Marcora SM, Casanova F, Fortes MB, et al. Validity and reliability of the Siconolfi Step Test for assessment of physical fitness in patients with systemic lupus erythematosus. Arthritis Rheum 2007;57:1007–11.
    1. Montalbán-Méndez C, Soriano-Maldonado A, Vargas-Hitos JA, et al. Cardiorespiratory fitness and age-related arterial stiffness in women with systemic lupus erythematosus. Eur J Clin Invest 2018;48:e12885.
    1. Soriano-Maldonado A, Morillas-de-Laguno P, Sabio J, et al. Effects of 12-week aerobic exercise on arterial stiffness, inflammation, and cardiorespiratory fitness in women with systemic LUPUS erythematosus: non-randomized controlled trial. J Clin Med 2018;7:E477.
    1. Gademan MGJ, Hosper K, Deutekom M, et al. A poor association was found between self-reported physical activity and estimated maximal oxygen uptake of sedentary multiethnic women. J Clin Epidemiol 2014;67:462–7.
    1. Correll S, Field J, Hutchinson H, et al. Reliability and validity of the Halo digital goniometer for shoulder range of motion in healthy subjects. Int J Sports Phys Ther 2018;13:707–14.
    1. Teresa Hervás M, Navarro Collado MJ, Peiró S, et al. Versión española del cuestionario DASH. Adaptación transcultural, fiabilidad, validez y sensibilidad a los cambios. Med Clin 2006;127:441–7.
    1. Beaton DE, Katz JN, Fossel AH, et al. 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. J Hand Ther 2001;14:128–46.
    1. Arraras JI, Garrido E, Pruja E, et al. El Cuestionario de Calidad de Vida de la EORTC QLQ-C30 (Versión 2.0). Estudio psicométrico con pacientes con cáncer de mama. Clínica y Salud 2000;11:329–49.
    1. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365–76.
    1. Vera R, Pruja E, Arraras JI, et al. The EORTC breast cancer quality questionnaire (QLQ-BR23): a psychometric study with Spanish patients. Psicol Conductual 2001;9:81–97.
    1. Sprangers MA, Groenvold M, Arraras JI, et al. The European Organization for research and treatment of cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996;14:2756–68.
    1. Belmonte Martínez R, Garin Boronat O, Segura Badía M, et al. Validación de la versión española del functional assessment of cancer therapy questionnaire for breast cancer (FACT-B+4). Med Clin 2011;137:685–8.
    1. Brady MJ, Cella DF, Mo F, et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol 1997;15:974–86.
    1. Dapueto JJ, del Carmen Abreu M, Francolino C, et al. Psychometric assessment of the MSAS-SF and the FACIT-fatigue scale in Spanish-speaking patients with cancer in Uruguay. J Pain Symptom Manage 2014;47:936–45.
    1. Yellen SB, Cella DF, Webster K, et al. Measuring fatigue and other anemia-related symptoms with the functional assessment of cancer therapy (FACT) measurement system. J Pain Symptom Manage 1997;13:63–74.
    1. González VM, Stewart A, Ritter PL, et al. Translation and validation of arthritis outcome measures into Spanish. Arthritis Rheum 1995;38:1429–46.
    1. Radloff LS. The CES-D scale: a self report depression scale for research in the general population. Appl Psychol Meas 1977;1:385–401.
    1. Requena Hernández C, López Fernández V, González Boto R, et al. Propiedades psicométricas de la escala de satisfacción con la vida en mujeres mayores activas. Rev Esp Geriatr Gerontol 2009;44:146–8.
    1. Lorenzo-Seva U, Calderon C, Ferrando PJ, et al. Psychometric properties and factorial analysis of invariance of the satisfaction with life scale (SWLS) in cancer patients. Qual Life Res 2019;28:1255–64.
    1. Sander AP, Hajer NM, Hemenway K, et al. Upper-extremity volume measurements in women with lymphedema: a comparison of measurements obtained via water displacement with geometrically determined volume. Phys Ther 2002;82:1201–12.
    1. Fong SSM, Ng SSM, Luk WS, et al. Effects of Qigong exercise on upper limb lymphedema and blood flow in survivors of breast cancer. Integr Cancer Ther 2014;13:54–61.
    1. Ahmed RL, Thomas W, Yee D, et al. Randomized controlled trial of weight training and lymphedema in breast cancer survivors. J Clin Oncol 2006;24:2765–72.
    1. Bracha J, Katz-Leurer M. The immediate effect of upper arm exercise compared with lower or combined upper and lower arm exercise on arm volume reduction in women with breast cancer related lymphedema: a randomized preliminary study. Rehabil Oncol 2012;30:3–8.

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