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Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

Recruiting
65-89 years
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion criteria:

  1. Age ≥65 years but <90 years;
  2. 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;
  3. Clinical Frailty Scale ≥5;
  4. Provide written informed consent.

Exclusion Criteria:

  1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
  2. Inability to communicate due to coma, profound dementia, or language barrier;
  3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
  4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
  5. 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;
  6. Other reasons that are considered unsuitable for study participation.

Study details
    Old Age; Debility
    Digestive Cancer
    Surgery
    Preoperative Rehabilitation
    Nutrition Therapy
    Outcomes

NCT04715581

Peking University First Hospital

14 August 2025

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