Exercise effects on functional capacity and quality of life in older patients with colorectal cancer: study protocol for the ECOOL randomized controlled trial

BMC Geriatrics

Study Protocol

Carlos Rodríguez-López¹  María Teresa Vidán²  Javier Ortiz-Alonso²  Jose Antonio Serra-Rexach²  Luis Miguel Jiménez-Gómez³  Paula Dujovne-Lindenbaum³  Maria Elena Pérez-Menéndez³  Nicolas María González-Senac⁴  Jennifer Mayordomo-Cava⁴  María Luisa Cruz-Arnés⁴  Angela Macías-Valle⁵  Gabriel Rodríguez-Romo⁶  Pedro L Valenzuela⁷ 

[1] Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), Madrid, Spain;Department of Geriatrics, Hospital General Universitario Gregorio Marañón. Health Research Institute Gregorio Marañón (IiSGM), Dr.Esquerdo 46, 28007, Madrid, Spain;Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), Madrid, Spain;Department of Geriatrics, Hospital General Universitario Gregorio Marañón. Health Research Institute Gregorio Marañón (IiSGM), Dr.Esquerdo 46, 28007, Madrid, Spain;School of Medicine, Department of Medicine, Universidad Complutense, Madrid, Spain;Colorectal Surgery Unit - General Surgery Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain;Department of Geriatrics, Hospital General Universitario Gregorio Marañón. Health Research Institute Gregorio Marañón (IiSGM), Dr.Esquerdo 46, 28007, Madrid, Spain;Faculty of Physical Activity and Sport Sciences (INEF), Universidad Politécnica de Madrid, Madrid, Spain;Faculty of Physical Activity and Sport Sciences (INEF), Universidad Politécnica de Madrid, Madrid, Spain;Centro de Investigación Biomédica en Red de Fragilidad y Envejecimiento Saludable (CIBERFES), Madrid, Spain;Physical Activity and Health Research Group (PaHerg), Research Institute of the Hospital Universitario 12 de Octubre (“Imas12”), Madrid, Spain;

关键词: Training;    Physical therapy;    Colon;    Prehabilitation;    Rehabilitation;    Ageing;   

DOI  :  10.1186/s12877-023-04026-6

 received in 2023-02-01, accepted in 2023-05-08,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSurgery and treatment for colorectal cancer (CRC) in the elderly patient increase the risk of developing post-operative complications, losing functional independence, and worsening health-related quality of life (HRQoL). There is a lack of high-quality randomized controlled trials evaluating the potential benefit of exercise as a countermeasure. The primary aim of this study is to evaluate the effectiveness of a home-based multicomponent exercise program for improving HRQoL and functional capacity in older adults undergoing CRC surgery and treatment.MethodsThis randomized, controlled, observer-blinded, single-center trial aims to randomize 250 patients (>74 years) to either an intervention or a control group (i.e., usual care). The intervention group will perform an individualized home-based multicomponent exercise program with weekly telephone supervision from diagnosis until three months post-surgery. The primary outcomes will be HRQoL (EORTC QLQ-C30; CR29; and ELD14) and functional capacity (Barthel Index and Short Physical Performance Battery), which will be assessed at diagnosis, at discharge, and one, three, and six months after surgery. Secondary outcomes will be frailty, physical fitness, physical activity, inspiratory muscle function, sarcopenia and cachexia, anxiety and depression, ambulation ability, surgical complications, and hospital length of stay, readmission and mortality.DiscussionThis study will examine the effects of an exercise program in older patients with CRC across a range of health-related outcomes. Expected findings are improvement in HRQoL and physical functioning. If proven effective, this simple exercise program may be applied in clinical practice to improve CRC care in older patients.Trial registrationClinicalTrials.gov ID: NCT05448846.

【 授权许可】

CC BY   
© The Author(s) 2023

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