NCT07456943

Brief Summary

The goal of this observational study is to evaluate the effectiveness of the multimodal prehabilitation program at the Siriraj Integrated Preoperative and Prehabilitation Center (SiPAP) on improving preoperative walking capacity and functional status in patients undergoing elective intraabdominal cancer surgery. The main question it aims to answer is: \- Does the prehabilitation program lead to a significant change in 6-minute walk distance (6MWD) at preoperative admission as compared to at baseline assessment? Participants will receive the structured multimodal prehabilitation program, which represents the standard of care for patients in the ERAS protocol at the study site. Outcomes will be measured at preoperative admission and at 1 and 3 months after surgery.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
May 2026Dec 2027

First Submitted

Initial submission to the registry

March 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 2, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

PrehabilitationFunctional capacityPreoperative careAbdominal cancer surgery

Outcome Measures

Primary Outcomes (1)

  • Six-minute walk distance (6MWD)

    A six-minute walk test will be performed on a standardized 30-meter indoor track following American Thoracic Society guidelines. Distance that participants can walk in 6 minutes will be record as six-minute walk distance (6MWD)

    Preoperative period and postoperative period (1 and 3 months)

Secondary Outcomes (3)

  • Dominant handgrip strength

    Preoperative period and postoperative period (1 and 3 months)

  • Lower limb strength, balance, and functional mobility

    Preoperative period and postoperative period (1 and 3 months)

  • Functional capacity

    Preoperative period and postoperative period (1 and 3 months)

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who enroll to Enhanced Recovery After Surgery (ERAS) program, Siriraj Hospital and referred to the SiPAP program.

You may qualify if:

  • Diagnosed with intraabdominal malignancy (e.g., colorectal, esophageal, gastric, pancreatic, hepatic, biliary tract, urinary bladder, or endometrial malignancies).
  • Schedules for elective major surgery and formally enrollment in the ERAS program at Siriraj Hospital. (at Siriraj Hospital, patients scheduled for pre-specific elective major surgeries are enrolled into the ERAS program as individual hospital protocols for each ERAS module. All patients are informed about the ERAS program by their surgical team.)
  • Referred to the SiPAP center for prehabilitation in accordance with the ERAS preoperative protocol, with a minimum preoperative time of 14 days before the scheduled surgery date.
  • Able to understand the study protocol and provide written informed consent.

You may not qualify if:

  • Have emergency surgery
  • Reschedule the surgery for an earlier date, allowing less than 14 days for prehabilitation.
  • Severe cardiopulmonary or musculoskeletal conditions that contraindicate exercise (e.g., unstable angina, decompensated heart failure, severe COPD, or orthopedic disability).
  • Cognitive impairment or psychiatric illness precluding participation in prehabilitation.
  • Refusal to participate.
  • Inability to comply with the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.

    PMID: 27592691BACKGROUND
  • Tew GA, Bedford R, Carr E, Durrand JW, Gray J, Hackett R, Lloyd S, Peacock S, Taylor S, Yates D, Danjoux G. Community-based prehabilitation before elective major surgery: the PREP-WELL quality improvement project. BMJ Open Qual. 2020 Mar;9(1):e000898. doi: 10.1136/bmjoq-2019-000898.

    PMID: 32213551BACKGROUND
  • Moran J, Guinan E, McCormick P, Larkin J, Mockler D, Hussey J, Moriarty J, Wilson F. The ability of prehabilitation to influence postoperative outcome after intra-abdominal operation: A systematic review and meta-analysis. Surgery. 2016 Nov;160(5):1189-1201. doi: 10.1016/j.surg.2016.05.014. Epub 2016 Jul 8.

    PMID: 27397681BACKGROUND
  • Thomas G, Tahir MR, Bongers BC, Kallen VL, Slooter GD, van Meeteren NL. Prehabilitation before major intra-abdominal cancer surgery: A systematic review of randomised controlled trials. Eur J Anaesthesiol. 2019 Dec;36(12):933-945. doi: 10.1097/EJA.0000000000001030.

    PMID: 31188152BACKGROUND
  • Barberan-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.

    PMID: 28489682BACKGROUND
  • Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.

    PMID: 24439570BACKGROUND
  • Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.

    PMID: 23052535BACKGROUND
  • Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.

    PMID: 21878237BACKGROUND
  • Hughes 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.

    PMID: 30788536BACKGROUND
  • Carli F, Scheede-Bergdahl C. Prehabilitation to enhance perioperative care. Anesthesiol Clin. 2015 Mar;33(1):17-33. doi: 10.1016/j.anclin.2014.11.002. Epub 2015 Jan 9.

    PMID: 25701926BACKGROUND

Study Officials

  • Wariya Vongchaiudomchoke, MD, MSc

    Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wariya Vongchaiudomchoke, MD, MSc

CONTACT

Mingkwan Wongyingsinn, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04