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Old Age; DebilityNCT04715581

Perioperative Multicomponent Rehabilitation and Outcomes in Elderly Patients With Frailty

A study testing Preoperative nutritional optimization, Perioperative exercise training and Postoperative exercise training in people with Old Age; Debility and Digestive Cancer, run by Peking University First Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is designed to investigate the effect of a perioperative multicomponent rehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer. Read more about this study

Who is it for?
Ages 65 to 89 years
Conditions the study is for
Old Age; Debility, Digestive Cancer, Surgery
What is being tested?
Preoperative nutritional optimization, Perioperative exercise training and Postoperative exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
1 siteChina
Study dates
25 Nov 2021to Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 89 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥65 years but <90 years;
  • 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;
  • Clinical Frailty Scale ≥5;
  • Provide written informed consent.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dong-Xin Wang, MD contact

+8613910731903

wangdongxin@hotmail.com

Huai-Jin Li, MD contact

+8613488659162

sophie.lee.coffee@gmail.com

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Huai-Jin Li, MD, sophie.lee.coffee@gmail.com

    Recruiting

Other trials in China

About this study

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

The study is designed to investigate the effect of a perioperative multicomponent rehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Read the 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 perioperative multicomponent rehabilitation on early and long-term outcomes in elderly patients with frailty.

Being tested
Preoperative nutritional optimization, Perioperative exercise training, Postoperative exercise training
Keywords
older patients, frailty, digestive cancer, nutrition therapy, outcomes, perioperative multicomponent rehabilitation
Medical subject headings
Frailty, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative nutritional optimizationDietary supplement

    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.

  • Perioperative exercise trainingBehavioural

    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.

  • Postoperative exercise trainingBehavioural

    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.
Study groups in NCT04715581
Study groupRoleWhat they receive
Perioperative multicomponent rehabilitation groupExperimentalPatients 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.
Receives: Dietary Supplement: Preoperative nutritional optimization; Behavioral: Perioperative exercise training; Behavioral: Postoperative exercise training
Control groupNo interventionPatients in the control group will maintain normal diet and normal activity before surgery, normal activity after surgery, and normal activity after discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 7 days after surgery.

  2. Recurrence-free survival after surgery.

    Events include recurrence, metastasis, or all-cause death, whichever come first.

    Measured: Up to two years after surgery.

Secondary outcomes (16)

  1. Intensive care unit admission after surgery (sub-study).

    Intensive care unit admission after surgery.

    Measured: Up to 30 days after surgery.

  2. Incidence of delirium within 7 days after surgery (sub-study).

    Delirium will be assessed with the 3-Dimensional Confusion Assessment Method.

    Measured: Up to 7 days after surgery.

  3. Time to oral fluid intake after surgery (sub-study).

    Time to oral fluid intake after surgery.

    Measured: Up to 30 days after surgery.

  4. Time to oral food intake after surgery (sub-study).

    Time to oral food intake after surgery.

    Measured: Up to 30 days after surgery.

  5. Time to out-of-bed activity after surgery (sub-study).

    Time to out-of-bed activity after surgery.

    Measured: Up to 30 days after surgery.

  6. 6-minute walk distance at hospital discharge (sub-study).

    6-minute walk distance at hospital discharge.

    Measured: At hospital discharge, up to 30 days after surgery.

  7. Length of hospital stay after surgery (sub-study).

    Length of hospital stay after surgery.

    Measured: Up to 30 days after surgery.

  8. 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.

    Measured: Up to 30 days after surgery.

  9. All-cause 30-day mortality after surgery (sub-study).

    All-cause 30-day mortality after surgery.

    Measured: Up to 30 days after surgery.

  10. 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.

    Measured: At 30 days after surgery.

  11. 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.

    Measured: At 30 days after surgery.

  12. 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.

    Measured: At 30 days after surgery.

  13. Overall survival after surgery.

    Events include all-cause death.

    Measured: Up to 2 years after surgery.

  14. 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.

    Measured: Up to 2 years after surgery.

  15. Event-free survival after surgery.

    Events include recurrence/metastasis, new-onset diseases, new-onset tumors, or all-cause mortality, whichever come first.

    Measured: Up to 2 years after surgery.

  16. Physical activity at 30 days after surgery (sub-study).

    Physical activity will be assessed with International Physical Activity Questionnaire-Long.

    Measured: At 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2021
  2. Study start25 Nov 2021
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized controlled trial.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04715581
Sponsor's protocol ID
2020-331
Status last verified
Oct 2026
First submitted
15 Jan 2021
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28055103

  • 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.

    PubMed 22881367

  • Song X, Mitnitski A, Rockwood K. Prevalence and 10-year outcomes of frailty in older adults in relation to deficit accumulation. J Am Geriatr Soc. 2010 Apr;58(4):681-7. doi: 10.1111/j.1532-5415.2010.02764.x. Epub 2010 Mar 22.

    PubMed 20345864

  • Mohile SG, Xian Y, Dale W, Fisher SG, Rodin M, Morrow GR, Neugut A, Hall W. Association of a cancer diagnosis with vulnerability and frailty in older Medicare beneficiaries. J Natl Cancer Inst. 2009 Sep 2;101(17):1206-15. doi: 10.1093/jnci/djp239. Epub 2009 Jul 28.

    PubMed 19638506

  • Verlaan S, Ligthart-Melis GC, Wijers SLJ, Cederholm T, Maier AB, de van der Schueren MAE. High Prevalence of Physical Frailty Among Community-Dwelling Malnourished Older Adults-A Systematic Review and Meta-Analysis. J Am Med Dir Assoc. 2017 May 1;18(5):374-382. doi: 10.1016/j.jamda.2016.12.074. Epub 2017 Feb 24.

    PubMed 28238676

  • Guyonnet S, Rolland Y. Screening for Malnutrition in Older People. Clin Geriatr Med. 2015 Aug;31(3):429-37. doi: 10.1016/j.cger.2015.04.009. Epub 2015 May 13.

    PubMed 26195101

  • Zhang DF, Su X, Meng ZT, Cui F, Li HL, Wang DX, Li XY. Preoperative severe hypoalbuminemia is associated with an increased risk of postoperative delirium in elderly patients: Results of a secondary analysis. J Crit Care. 2018 Apr;44:45-50. doi: 10.1016/j.jcrc.2017.09.182. Epub 2017 Sep 29.

    PubMed 29055835

  • Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) Investigators. Preoperative vitamin D deficiency increases the risk of postoperative cognitive dysfunction: a predefined exploratory sub-analysis. Acta Anaesthesiol Scand. 2018 Aug;62(7):924-935. doi: 10.1111/aas.13116. Epub 2018 Mar 26.

    PubMed 29578249

  • Cruz-Jentoft AJ, Kiesswetter E, Drey M, Sieber CC. Nutrition, frailty, and sarcopenia. Aging Clin Exp Res. 2017 Feb;29(1):43-48. doi: 10.1007/s40520-016-0709-0. Epub 2017 Feb 2.

    PubMed 28155181

  • Wei K, Nyunt MSZ, Gao Q, Wee SL, Ng TP. Frailty and Malnutrition: Related and Distinct Syndrome Prevalence and Association among Community-Dwelling Older Adults: Singapore Longitudinal Ageing Studies. J Am Med Dir Assoc. 2017 Dec 1;18(12):1019-1028. doi: 10.1016/j.jamda.2017.06.017. Epub 2017 Aug 10.

    PubMed 28804010

  • Laur CV, McNicholl T, Valaitis R, Keller HH. Malnutrition or frailty? Overlap and evidence gaps in the diagnosis and treatment of frailty and malnutrition. Appl Physiol Nutr Metab. 2017 May;42(5):449-458. doi: 10.1139/apnm-2016-0652. Epub 2017 Mar 21.

    PubMed 28322060

  • Ethun CG, Bilen MA, Jani AB, Maithel SK, Ogan K, Master VA. Frailty and cancer: Implications for oncology surgery, medical oncology, and radiation oncology. CA Cancer J Clin. 2017 Sep;67(5):362-377. doi: 10.3322/caac.21406. Epub 2017 Jul 21.

    PubMed 28731537

  • Lin HS, Watts JN, Peel NM, Hubbard RE. Frailty and post-operative outcomes in older surgical patients: a systematic review. BMC Geriatr. 2016 Aug 31;16(1):157. doi: 10.1186/s12877-016-0329-8.

    PubMed 27580947

  • Fagard K, Leonard S, Deschodt M, Devriendt E, Wolthuis A, Prenen H, Flamaing J, Milisen K, Wildiers H, Kenis C. The impact of frailty on postoperative outcomes in individuals aged 65 and over undergoing elective surgery for colorectal cancer: A systematic review. J Geriatr Oncol. 2016 Nov;7(6):479-491. doi: 10.1016/j.jgo.2016.06.001. Epub 2016 Jun 21.

    PubMed 27338516

  • Richards SJG, Frizelle FA, Geddes JA, Eglinton TW, Hampton MB. Frailty in surgical patients. Int J Colorectal Dis. 2018 Dec;33(12):1657-1666. doi: 10.1007/s00384-018-3163-y. Epub 2018 Sep 14.

    PubMed 30218144

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative nutritional optimization, Perioperative exercise training and Postoperative exercise training in people with Old Age; Debility and Digestive Cancer, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dong-Xin Wang, MD (+8613910731903, wangdongxin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A composite of delirium and non-delirium complications within 7 days after surgery (sub-study). (time frame: Up to 7 days after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04715581, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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