Preoperative Prehabilitation in Older Adults Undergoing HepatectomyNCT07877311
Prehabilitation Before Liver Surgery in Older Adults
A study testing Preoperative Prehabilitation Program in people with Preoperative Prehabilitation in Older Adults Undergoing Hepatectomy, run by Lining Xu at 6 sites in China.
Trial summary
Many older adults who need liver surgery (hepatectomy) are physically weak before their operation. This can make recovery harder and may lead to more complications after surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Preoperative Prehabilitation in Older Adults Undergoing Hepatectomy
- What is being tested?
- Preoperative Prehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2021to Dec 2027
- Phase
- Interventional
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective liver resection, Child-Pugh class A or B, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and ability to understand and comply with the prehabilitation programme
Who cannot join
- preoperative Barthel Index <70 (indicating pre-existing severe functional dependence), inability to participate due to severe cognitive impairment (Mini-Mental State Examination <20), uncontrolled psychiatric disease, severe musculoskeletal disorders limiting exercise, active coronary artery disease or heart failure (New York Heart Association class III or IV), end-stage renal disease requiring dialysis, concurrent major surgery, pregnancy or lactation, and enrolment in another interventional trial within 30 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Shenzhen Bao'an District Songgang People's Hospital
Shenzhen, Guangdong, 518105
Hubei Province Integrated Hospital of Chinese and Western Medicine
Wuhan, Hubei, 430015
Affiliated Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: Preoperative Prehabilitation for Older Adults Undergoing Hepatectomy
Many older adults who need liver surgery (hepatectomy) are physically weak before their operation. This can make recovery harder and may lead to more complications after surgery. "Prehabilitation" is a program of exercise and nutrition support that takes place before surgery, with the goal of helping patients get stronger and better prepared.
This study is testing whether a preoperative prehabilitation program helps older adults recover better after liver surgery. We want to find out if it reduces complications and helps patients return to their normal activities sooner.
Read more
We are looking for adults aged 65 and older who are scheduled to have liver surgery. Participants will be assigned by chance to either the prehabilitation program or standard care before surgery. The prehabilitation program includes guided exercise and nutrition advice over several weeks before the operation.
If this program works, it could become a routine part of care for older adults preparing for liver surgery, helping them have safer operations and smoother recoveries.
- Being tested
- Preoperative Prehabilitation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Prehabilitation ProgramBehavioural
Participants in the prehabilitation group receive a multimodal preoperative program initiated 2-4 weeks before scheduled hepatectomy. The program includes: (1) individualized supervised or home-based exercise training (aerobic and resistance exercises, 3-5 sessions per week); (2) nutritional assessment and counseling with protein supplementation as needed; and (3) psychological support including relaxation techniques and preoperative education. The program is delivered by a multidisciplinary team (physiotherapist, dietitian, and nurse) through weekly in-person or telehealth sessions. Participants also receive an individualized home program. The intervention continues until the day before surgery. This program is in addition to standard preoperative care. The control group receives standard preoperative care alone, without structured exercise, nutritional, or psychological prehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Group | Experimental | Not described Receives: Behavioral: Preoperative Prehabilitation Program |
| Control Group | Active comparator | Not described Receives: Behavioral: Preoperative Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of recovery of activities of daily living (ADL)
Measured: up to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jan 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Preoperative Prehabilitation in Older Adults Undergoing HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lining Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lining Xu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877311
- Sponsor's protocol ID
- ChinaPLAGH-S2022-664-01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the primary publication (including text, tables, figures, and appendices) will be shared. Additional documents available will include the Study Protocol and Statistical Analysis Plan. Data will become available beginning 6 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Proposals should be directed to \[xu\_lining@aliyun.com\]. To gain access, data requestors will need to sign a data access agreement.
Publications
Chan AW, Altman DG. Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors. BMJ. 2005 Apr 2;330(7494):753. doi: 10.1136/bmj.38356.424606.8F. Epub 2005 Jan 28.
PubMed 15681569Hughes MJ, Hackney RJ, Lamb PJ, Wigmore SJ, Christopher Deans DA, Skipworth RJE. Prehabilitation Before Major Abdominal Surgery: A Systematic Review and Meta-analysis. World J Surg. 2019 Jul;43(7):1661-1668. doi: 10.1007/s00268-019-04950-y.
PubMed 30788536Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
PubMed 26606383Lobo DN, Gianotti L, Adiamah A, Barazzoni R, Deutz NEP, Dhatariya K, Greenhaff PL, Hiesmayr M, Hjort Jakobsen D, Klek S, Krznaric Z, Ljungqvist O, McMillan DC, Rollins KE, Panisic Sekeljic M, Skipworth RJE, Stanga Z, Stockley A, Stockley R, Weimann A. Perioperative nutrition: Recommendations from the ESPEN expert group. Clin Nutr. 2020 Nov;39(11):3211-3227. doi: 10.1016/j.clnu.2020.03.038. Epub 2020 Apr 18.
PubMed 32362485Gillis C, Carli F. Promoting Perioperative Metabolic and Nutritional Care. Anesthesiology. 2015 Dec;123(6):1455-72. doi: 10.1097/ALN.0000000000000795.
PubMed 26248016VanderWeele TJ, Ding P. Sensitivity Analysis in Observational Research: Introducing the E-Value. Ann Intern Med. 2017 Aug 15;167(4):268-274. doi: 10.7326/M16-2607. Epub 2017 Jul 11.
PubMed 28693043Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
PubMed 21236455Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.
PubMed 28385477Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
PubMed 30426190Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11.
PubMed 26864728Sebio Garcia R, Yanez-Brage MI, Gimenez Moolhuyzen E, Salorio Riobo M, Lista Paz A, Borro Mate JM. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial. Clin Rehabil. 2017 Aug;31(8):1057-1067. doi: 10.1177/0269215516684179. Epub 2016 Dec 20.
PubMed 28730888van Rooijen SJ, Molenaar CJL, Schep G, van Lieshout RHMA, Beijer S, Dubbers R, Rademakers N, Papen-Botterhuis NE, van Kempen S, Carli F, Roumen RMH, Slooter GD. Making Patients Fit for Surgery: Introducing a Four Pillar Multimodal Prehabilitation Program in Colorectal Cancer. Am J Phys Med Rehabil. 2019 Oct;98(10):888-896. doi: 10.1097/PHM.0000000000001221.
PubMed 31090551Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.
PubMed 31968063Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PubMed 28489682Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe.
PubMed 23756434