Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty
- Conditions
- Old Age; DebilityNutrition TherapyOutcomesSurgeryDigestive CancerPreoperative Rehabilitation
- Interventions
- Dietary Supplement: Preoperative nutritional optimizationBehavioral: Preoperative exercise trainingBehavioral: Postoperative exercise training
- Registration Number
- NCT04715581
- Lead Sponsor
- Peking University First Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 538
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multicomponent prehabilitation group Preoperative exercise training 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. Multicomponent prehabilitation group Preoperative nutritional optimization 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. Multicomponent prehabilitation group Postoperative exercise training 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.
- Primary Outcome Measures
Name Time Method Recurrence-free survival after surgery. Up to two years after surgery. Events include recurrence, metastasis, or all-cause death, whichever come first.
A composite of delirium and non-delirium complications within 7 days after surgery (sub-study). Up to 7 days after surgery. 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.
- Secondary Outcome Measures
Name Time Method All-cause 30-day mortality after surgery (sub-study). Up to 30 days after surgery. All-cause 30-day mortality after surgery.
Incidence of delirium within 7 days after surgery (sub-study). Up to 7 days after surgery. Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.
Quality of life at 30 days after surgery (sub-study). At 30 days after surgery. 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.
Cancer specific survival after surgery. Up to 2 years 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.
Physical activity at 30 days after surgery (sub-study). At 30 days after surgery. Physical activity will be assessed with International Physical Activity Questionnaire-Long.
Incidence of non-delirium complication within 30 days after surgery (sub-study). Up to 30 days after surgery. 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.
Sleep quality at 30 days after surgery (sub-study). At 30 days after surgery. 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.
Overall survival after surgery. Up to 2 years after surgery. Events include all-cause death.
Intensive care unit admission after surgery (sub-study). Up to 30 days after surgery. Intensive care unit admission after surgery.
Time to oral fluid intake after surgery (sub-study). Up to 30 days after surgery. Time to oral fluid intake after surgery.
Time to out-of-bed activity after surgery (sub-study). Up to 30 days after surgery. Time to out-of-bed activity after surgery.
Time to oral food intake after surgery (sub-study). Up to 30 days after surgery. Time to oral food intake after surgery.
6-minute walk distance at hospital discharge (sub-study). At hospital discharge, up to 30 days after surgery. 6-minute walk distance at hospital discharge.
Length of hospital stay after surgery (sub-study). Up to 30 days after surgery. Length of hospital stay after surgery.
Cognitive function at 30 days after surgery (sub-study). At 30 days after surgery. 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.
Event-free survival after surgery. Up to 2 years after surgery. Events include recurrence/metastasis, new-onset diseases, new-onset tumors, or all-cause mortality, whichever come first.
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China