Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

Официальное название

Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study

Обзор

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Подробное описание

Frailty is an age-related syndrome characterized with diminished physiological reserve that results in decreased homeostatic capacity and increased vulnerability to any stress from minor to major. Approximately 10% to 20% of adults aged 65 years and older present with frailty, and the incidence doubles among those of 85 years and older. Among elderly cancer patients especially those with digestive cancer, the prevalence of frailty and pre-frailty can be as high as 50%. Malnutrition often coexists with frailty, and indeed contribute to the development of frailty. As a matter of fact, the proportion of malnutrition also increases with age even in high-income countries.

Frailty is strongly associated with worsening outcomes in surgical patients, including higher delirium, high non-delirium complications, high perioperative mortality, as well as decreased activity of daily life, cognitive dysfunction and work disability in long-term survivors. Furthermore, malnutrition as a prominent factor in the development of frailty also has adverse impacts on the duration of hospitalization, complications, and survival after surgery. Therefore, it is urgently needed to understand how to enhance the recovery of these patients following surgery.

Exercises and rehabilitation, in combination with nutritional supplement, may reverse or mitigate frailty, promote postoperative recovery, and improve clinical outcomes. However, the reported effectiveness varies with interventions and are not sufficiently robust to guide good clinical practice. The purpose of this study is to investigate the effect of multimodal prehabilitation on early and long-term outcomes in elderly patients with frailty.

Вмешательства

• Пищевая добавка Preoperative nutritional optimization
  1. Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7). 2. Protocol of nutritional optimization: Enteral nutritional powder (Ensure for patients without diabetes and Glucerna for patients with diabetes) twice a day. The target protein intake is 1.5-1.8 g/kg/d. Patients with iron deficient anemia (hemoglobin \<130 g/L for men and \<120 g/L for women) will be given oral iron therapy. 3. The duration of nutritional optimi
• Поведенческое Preoperative exercise training
  1. The respiratory training will be performed for at least 2-3 times per day. Respiratory training include thoracic breathing exercise and cough training. 2. Aerobic exercise will be performed for at least 1-2 times per day. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible. 3. Every training should be last for 45 minutes to 1 hour. If the patient can
• Поведенческое Postoperative exercise training
  1. Muscle strength training in the bedside and walking in the ward. 2. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible. 3. Exercise training is performed under the supervision of physiotherpists durign hospital stay, and is reminded by regular telephone calls and phone messages after hospital discharge.

Первичные конечные точки

• A composite of delirium and non-delirium complications within 7 days after surgery (sub-study). [Срок оценки: Up to 7 days after surgery.]
• Recurrence-free survival after surgery. [Срок оценки: Up to two years after surgery.]

Вторичные конечные точки (12)

• Intensive care unit admission after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• Incidence of delirium within 7 days after surgery (sub-study). [Срок оценки: Up to 7 days after surgery.]
• Time to oral fluid intake after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• Time to oral food intake after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• Time to out-of-bed activity after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• 6-minute walk distance at hospital discharge (sub-study). [Срок оценки: At hospital discharge, up to 30 days after surgery.]
• Length of hospital stay after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• Incidence of non-delirium complication within 30 days after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• All-cause 30-day mortality after surgery (sub-study). [Срок оценки: Up to 30 days after surgery.]
• Quality of life at 30 days after surgery (sub-study). [Срок оценки: At 30 days after surgery.]
• Cognitive function at 30 days after surgery (sub-study). [Срок оценки: At 30 days after surgery.]
• Sleep quality at 30 days after surgery (sub-study). [Срок оценки: At 30 days after surgery.]

Критерии участия

Критерии включения

• Age ≥65 years but <90 years;
• Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract;
• Clinical Frailty Scale ≥5;
• Provide written informed consent.

Критерии исключения

• Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
• Inability to communicate due to coma, profound dementia, or language barrier;
• Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
• Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
• Severe heart dysfunction (left ventricular ejection fraction <30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher;
• Other reasons that are considered unsuitable for study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 1 центр

• Peking University First Hospital — Пекин

Публикации

• Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. PMID 28055103
• Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6. PMID 22881367
• Song X, Mitnitski A, Rockwood K. Prevalence and 10-year outcomes of frailty in older adults in relation to deficit accumulation. J Am Geriatr Soc. 2010 Apr;58(4):681-7. doi: 10.1111/j.1532-5415.2010.02764.x. Epub 2010 Mar 22. PMID 20345864
• Mohile SG, Xian Y, Dale W, Fisher SG, Rodin M, Morrow GR, Neugut A, Hall W. Association of a cancer diagnosis with vulnerability and frailty in older Medicare beneficiaries. J Natl Cancer Inst. 2009 Sep 2;101(17):1206-15. doi: 10.1093/jnci/djp239. Epub 2009 Jul 28. PMID 19638506
• Verlaan S, Ligthart-Melis GC, Wijers SLJ, Cederholm T, Maier AB, de van der Schueren MAE. High Prevalence of Physical Frailty Among Community-Dwelling Malnourished Older Adults-A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2017 May 1;18(5):374-382. doi: 10.1016/j.jamda.2016.12.074. Epub 2017 Feb 24. PMID 28238676
• Guyonnet S, Rolland Y. Screening for Malnutrition in Older People. Clin Geriatr Med. 2015 Aug;31(3):429-37. doi: 10.1016/j.cger.2015.04.009. Epub 2015 May 13. PMID 26195101
• Zhang DF, Su X, Meng ZT, Cui F, Li HL, Wang DX, Li XY. Preoperative severe hypoalbuminemia is associated with an increased risk of postoperative delirium in elderly patients: Results of a secondary analysis. J Crit Care. 2018 Apr;44:45-50. doi: 10.1016/j.jcrc.2017.09.182. Epub 2017 Sep 29. PMID 29055835
• Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) Investigators. Preoperative vitamin D deficiency increases the risk of postoperative cognitive dysfunction: a predefined exploratory sub-analysis. Acta Anaesthesiol Scand. 2018 Aug;62(7):924-935. doi: 10.1111/aas.13116. Epub 2018 Mar 26. PMID 29578249

Идентификаторы

NCT: NCT04715581 · 2020-331

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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