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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent prehabilitation group | Experimental | 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. |
|
| Control group | No Intervention | Patients in the control group will maintain normal diet and normal activity before surgery, normal activity after surgery, and normal activity after discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative nutritional optimization | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Recurrence-free survival after surgery. | Events include recurrence, metastasis, or all-cause death, whichever come first. | Up to two years after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensive care unit admission after surgery (sub-study). | Intensive care unit admission after surgery. | Up to 30 days after surgery. |
| Incidence of delirium within 7 days after surgery (sub-study). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Subjective sleep quality after surgery (sub-study). |
Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Xin Wang, MD | Contact | +8613910731903 | wangdongxin@hotmail.com | |
| Huai-Jin Li, MD | Contact | +8613488659162 | sophie.lee.coffee@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28055103 | Background | Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5. | |
| 22881367 | Background | Collard RM, Boter H, Schoevers RA, Oude Voshaar RC. Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc. 2012 Aug;60(8):1487-92. doi: 10.1111/j.1532-5415.2012.04054.x. Epub 2012 Aug 6. |
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This is a randomized controlled trial.
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|
| Preoperative exercise training | Behavioral |
|
|
| Postoperative exercise training | Behavioral |
|
|
Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.
| Up to 7 days after surgery. |
| Time to oral fluid intake after surgery (sub-study). | Time to oral fluid intake after surgery. | Up to 30 days after surgery. |
| Time to oral food intake after surgery (sub-study). | Time to oral food intake after surgery. | Up to 30 days after surgery. |
| Time to out-of-bed activity after surgery (sub-study). | Time to out-of-bed activity after surgery. | Up to 30 days after surgery. |
| 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. |
| Length of hospital stay after surgery (sub-study). | Length of hospital stay after surgery. | 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. | Up to 30 days after surgery. |
| All-cause 30-day mortality after surgery (sub-study). | All-cause 30-day mortality after surgery. | 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. | 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. | 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. | At 30 days after surgery. |
| Overall survival after surgery. | Events include all-cause death. | 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. | 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. | 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. | At 30 days after surgery. |
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. |
| 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. |
| 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. |
| 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. |
| 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) |
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
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