Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04715581
• Other study ID #: 2020-331
• Status: Recruiting
• Phase: N/A
• Start date: November 25, 2021
• Est. completion date: December 2027

Study information

• Verified date: July 2023
• Source: Peking University First Hospital
• Contact: Dong-Xin Wang, MD
• Phone: +8613910731903
• Email: wangdongxin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 538
• Est. completion date: December 2027
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 89 Years

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.

Related Conditions & MeSH terms

• Digestive Cancer
• Frailty
• Nutrition Therapy
• Old Age; Debility
• Outcomes
• Preoperative Rehabilitation
• Surgery

Intervention

Dietary Supplement:
• Preoperative nutritional optimization
Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7). 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. The duration of nutritional optimization: The day admitted to the hospital to the surgery to one day prior to the surgery.

Behavioral:
• Preoperative exercise training
The respiratory training will be performed for at least 2-3 times per day. Respiratory training include thoracic breathing exercise and cough training. 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. 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. The duration of exercise training: The day admitted to the hospital to the surgery to one day prior to the surgery.
• Postoperative exercise training
Muscle strength training in the bedside and walking in the ward. 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. 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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (40)

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* Note: There are 40 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intensity of pain after surgery (sub-study).	Intensity of pain will be assessed twice daily with the numeric rating scale which is a 11-point scale where 0=no pain and 10=the worst pain.	Up to 7 days after surgery.
Other	Subjective sleep quality after surgery (sub-study).	Subjective sleep quality will be assessed daily with the numeric rating scale which is a 11-point scale where 0=the best sleep and 10=the worst sleep.	Up to 7 days after surgery.
Other	Sleep architecture during the night of surgery (sub-study, part of enrolled patients).	Sleep will be evaluated with the polysomnographic monitoring during the night of surgery.	During the night of surgery.
Other	Quality of life at 1 year 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.	At 1 year after surgery.
Other	Cognitive function at 1 year 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.	At 1 year after surgery.
Other	Serum level of irisin before anesthesia	Blood samples will be collected before anesthesia. Serum will be separated and immediately frozen at -80 °C. Irisin concentration will be measured using a commercial ELISA kit, according to the manufacturer's instructions.	Intraoperative (Before anesthesia on the day of surgery)
Other	Serum level of irisin on postoperative day 1	Blood samples will be collected before anesthesia. Serum will be separated and immediately frozen at -80 °C. Irisin concentration will be measured using a commercial ELISA kit, according to the manufacturer's instructions.	At the first day after surgery
Other	Physical activity at 3 months, 6 months and 1 year after surgery.	Physical activity will be assessed with International Physical Activity Questionnaire-Long.	At 3 months, 6 months and 1 year after surgery
Primary	A 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.	Up to 7 days after surgery.
Primary	Recurrence-free survival after surgery.	Events include recurrence, metastasis, or all-cause death, whichever come first.	Up to two years after surgery.
Secondary	Intensive care unit admission after surgery (sub-study).	Intensive care unit admission after surgery.	Up to 30 days after surgery.
Secondary	Incidence of delirium within 7 days after surgery (sub-study).	Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.	Up to 7 days after surgery.
Secondary	Time to oral fluid intake after surgery (sub-study).	Time to oral fluid intake after surgery.	Up to 30 days after surgery.
Secondary	Time to oral food intake after surgery (sub-study).	Time to oral food intake after surgery.	Up to 30 days after surgery.
Secondary	Time to out-of-bed activity after surgery (sub-study).	Time to out-of-bed activity after surgery.	Up to 30 days after surgery.
Secondary	6-minute walk distance at hospital discharge (sub-study).	6-minute walk distance at hospital discharge.	At hospital discharge, up to 30 days after surgery.
Secondary	Length of hospital stay after surgery (sub-study).	Length of hospital stay after surgery.	Up to 30 days after surgery.
Secondary	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.	Up to 30 days after surgery.
Secondary	All-cause 30-day mortality after surgery (sub-study).	All-cause 30-day mortality after surgery.	Up to 30 days after surgery.
Secondary	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.	At 30 days after surgery.
Secondary	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.	At 30 days after surgery.
Secondary	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.	At 30 days after surgery.
Secondary	Overall survival after surgery.	Events include all-cause death.	Up to 2 years after surgery.
Secondary	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.	Up to 2 years after surgery.
Secondary	Event-free survival after surgery.	Events include recurrence/metastasis, new-onset diseases, new-onset tumors, or all-cause mortality, whichever come first.	Up to 2 years after surgery.
Secondary	Physical activity at 30 days after surgery (sub-study).	Physical activity will be assessed with International Physical Activity Questionnaire-Long.	At 30 days after surgery.