Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

Peking University

Status: Enrolling

Conditions: Preoperative Rehabilitation; Surgery; Digestive Cancer; Nutrition Therapy; Outcomes; Old Age; Debility

Treatments: Dietary Supplement: Preoperative nutritional optimization; Behavioral: Preoperative exercise training; Behavioral: Postoperative exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT04715581

2020-331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: All

Ages: 65 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 2 patient groups

Multicomponent prehabilitation group

Experimental group

Description:

Patients in the intervention group will receive nutritional optimization and exercise training before the surgery, exercise training after the surgery, and home-based rehabilitation after discharge.

Treatment:

Behavioral: Postoperative exercise training

Behavioral: Preoperative exercise training

Dietary Supplement: Preoperative nutritional optimization

Control group

No Intervention group

Description:

Patients in the control group will maintain normal diet and normal activity before surgery, normal activity after surgery, and normal activity after discharge.