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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
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 optimization: The day admitted to the hospital to the surgery to one day prior to the surgery.
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 not tolerate, the training time should be reduce to 30 minutes. 4. The duration of exercise training: The day admitted to the hospital to the surgery to one day prior to the surgery.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGA composite of delirium and non-delirium complications within 7 days after surgery (sub-study).
Delirium will be assessed with the 3-Dimensional Confusion Assessment Method. Non-delirium complications are defined as new onset medical events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or higher on Clavien-Dindo classification.
Time frame: Up to 7 days after surgery.
Recurrence-free survival after surgery.
Events include recurrence, metastasis, or all-cause death, whichever come first.
Time frame: Up to two years after surgery.
Intensive care unit admission after surgery (sub-study).
Intensive care unit admission after surgery.
Time frame: Up to 30 days after surgery.
Incidence of delirium within 7 days after surgery (sub-study).
Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.
Time frame: Up to 7 days after surgery.
Time to oral fluid intake after surgery (sub-study).
Time to oral fluid intake after surgery.
Time frame: Up to 30 days after surgery.
Time to oral food intake after surgery (sub-study).
Time to oral food intake after surgery.
Time frame: Up to 30 days after surgery.
Time to out-of-bed activity after surgery (sub-study).
Time to out-of-bed activity after surgery.
Time frame: Up to 30 days after surgery.
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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.
6-minute walk distance at hospital discharge (sub-study).
6-minute walk distance at hospital discharge.
Time frame: At hospital discharge, up to 30 days after surgery.
Length of hospital stay after surgery (sub-study).
Length of hospital stay after surgery.
Time frame: Up to 30 days after surgery.
Incidence of non-delirium complication within 30 days after surgery (sub-study).
Non-delirium complications are defined as new onset medical events other than delirium that are harmful to patients' recovery and required therapeutic intervention, i.e., grade II or higher on Clavien-Dindo classification.
Time frame: Up to 30 days after surgery.
All-cause 30-day mortality after surgery (sub-study).
All-cause 30-day mortality after surgery.
Time frame: Up to 30 days after surgery.
Quality of life at 30 days after surgery (sub-study).
Quality of life will be assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
Time frame: At 30 days after surgery.
Cognitive function at 30 days after surgery (sub-study).
Cognitive function will be assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function.
Time frame: At 30 days after surgery.
Sleep quality at 30 days after surgery (sub-study).
Sleep quality will be assessed with the Pittsburgh sleep quality index which is a 9-item questionnaire that assess subjective quality of sleep during the past 1 month. The score ranges from 0 to 21, with higher score indicating poor sleep quality.
Time frame: At 30 days after surgery.
Overall survival after surgery.
Events include all-cause death.
Time frame: Up to 2 years after surgery.
Cancer specific survival after surgery.
Events are cancer-specific death which is defined as death fully attributable to the cancer for which the index surgery is performed and usually involving cancer recurrence and/or metastasis after exclusion of other causes such as stroke and myocardial infarction. Deaths from other causes are censored at the time of death.
Time frame: Up to 2 years after surgery.
Event-free survival after surgery.
Events include recurrence/metastasis, new-onset diseases, new-onset tumors, or all-cause mortality, whichever come first.
Time frame: Up to 2 years after surgery.
Physical activity at 30 days after surgery (sub-study).
Physical activity will be assessed with International Physical Activity Questionnaire-Long.
Time frame: At 30 days after surgery.