PrehabilitationNCT07456943
Prehabilitation to Enhance Preoperative Function in Elderly Undergoing Abdominal Malignancy Surgery
An observational study of Prehabilitation and Functional Capacity, run by Siriraj Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Prehabilitation, Functional Capacity
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2027
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who enroll to Enhanced Recovery After Surgery (ERAS) program, Siriraj Hospital and referred to the SiPAP program.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prehabilitation to Enhance Preoperative Function in Elderly Undergoing Abdominal Malignancy Surgery: A Prospective Study at Siriraj Hospital
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.
Read the detailed description
Surgical resection remains the mainstay of treatment for patients with intraabdominal malignancies such as colorectal, gastric, hepatobiliary, and pancreatic cancers. However, patients with cancer often present with impaired physical function, malnutrition, sarcopenia, and psychological distress, which may negatively impact their ability to tolerate surgery and recover postoperatively. Intraabdominal cancer surgery, particularly major procedures, imposes significant physiological stress, and reduced preoperative physical fitness has been associated with poor postoperative outcomes, including longer length of stay, increased complications, and delayed return to baseline function.
Prehabilitation, defined as the process of enhancing a patient's functional capacity before surgery to improve postoperative outcomes, has emerged as a promising strategy to address these challenges. Multimodal prehabilitation, typically involving aerobic and resistance exercise, nutritional optimization, and psychological support, has been shown to improve preoperative functional capacity, measured by objective tests such as the Six-Minute Walk Test (6MWT), and to enhance postoperative recovery.
The 6MWT is a simple, reproducible tool that reflects integrated cardiopulmonary and musculoskeletal function, and it has been widely used as a functional assessment in the preoperative setting. A minimal clinically important difference (MCID) of 20-30 meters has been suggested in various populations.Studies in colorectal and upper gastrointestinal cancer surgery have demonstrated that prehabilitation can lead to meaningful improvements in 6MWT distance, muscle strength, and health-related quality of life before surgery.
However, most existing studies have been conducted in Western countries, and there is limited data regarding the feasibility and benefits of prehabilitation in Asian populations, including Thailand, where differences in patient characteristics, healthcare systems, and cultural factors may influence outcomes. Furthermore, many prior studies have focused on postoperative endpoints, whereas preoperative functional improvement-as a modifiable, short-term goal-is less frequently studied despite its potential clinical and prognostic significance.
This prospective observational cohort study aims 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 SiPAP at Siriraj Hospital, Bangkok, Thailand, has incorporated this multimodal prehabilitation program as part of the standard of care within the Enhanced Recovery After Surgery (ERAS) protocol. The findings of this study will clarify the feasibility and clinical utility of implementing prehabilitation in Thai patients undergoing cancer surgery and may inform the design of future randomized controlled trials or support the development of evidence-based guidelines.
- Conditions
- Prehabilitation, Functional Capacity
- Keywords
- Prehabilitation, Functional capacity, Preoperative care, Abdominal cancer surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Preoperative period and postoperative period (1 and 3 months)
Secondary outcomes (3)
Dominant handgrip strength
Dominant handgrip strength in kilogram
Measured: Preoperative period and postoperative period (1 and 3 months)
Lower limb strength, balance, and functional mobility
Lower limb strength, balance, and functional mobility quantified by time (seconds) use during Five-time chair stand test
Measured: Preoperative period and postoperative period (1 and 3 months)
Functional capacity
Functional capacity status in metabolic equivalents (METs) using Duke Activity Status Index (DASI): score ranged 0 - 58.2
Measured: Preoperative period and postoperative period (1 and 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study startMay 2026 (estimated)
- Primary completionSep 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 (10)Papers the sponsor has linked to this study.
- Other trials for PrehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Wariya Vongchaiudomchoke, MD, MSc, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456943
- Sponsor's protocol ID
- 1145/2568 (IRB1)
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27592691Tew 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.
PubMed 32213551Moran 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.
PubMed 27397681Thomas 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.
PubMed 31188152Barberan-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 28489682Santa 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.
PubMed 24439570Li 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.
PubMed 23052535Mayo 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.
PubMed 21878237Hughes 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 30788536Carli 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.
PubMed 25701926
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation to Enhance Preoperative Function in Elderly Undergoing Abdominal Malignancy Surgery: A Prospective Study at Siriraj Hospital
- ClinicalTrials.gov ID
- NCT07456943
- Acronym / sponsor ID
- 1145/2568 (IRB1)
- Conditions
- Prehabilitation, Functional Capacity
- Keywords
- Prehabilitation, Functional capacity, Preoperative care, Abdominal cancer surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Surgical resection remains the mainstay of treatment for patients with intraabdominal malignancies such as colorectal, gastric, hepatobiliary, and pancreatic cancers. However, patients with cancer often present with impaired physical function, malnutrition, sarcopenia, and psychological distress, which may negatively impact their ability to tolerate surgery and recover postoperatively. Intraabdominal cancer surgery, particularly major procedures, imposes significant physiological stress, and reduced preoperative physical fitness has been associated with poor postoperative outcomes, including longer length of stay, increased complications, and delayed return to baseline function.
Prehabilitation, defined as the process of enhancing a patient's functional capacity before surgery to improve postoperative outcomes, has emerged as a promising strategy to address these challenges. Multimodal prehabilitation, typically involving aerobic and resistance exercise, nutritional optimization, and psychological support, has been shown to improve preoperative functional capacity, measured by objective tests such as the Six-Minute Walk Test (6MWT), and to enhance postoperative recovery.
The 6MWT is a simple, reproducible tool that reflects integrated cardiopulmonary and musculoskeletal function, and it has been widely used as a functional assessment in the preoperative setting. A minimal clinically important difference (MCID) of 20-30 meters has been suggested in various populations.Studies in colorectal and upper gastrointestinal cancer surgery have demonstrated that prehabilitation can lead to meaningful improvements in 6MWT distance, muscle strength, and health-related quality of life before surgery.
However, most existing studies have been conducted in Western countries, and there is limited data regarding the feasibility and benefits of prehabilitation in Asian populations, including Thailand, where differences in patient characteristics, healthcare systems, and cultural factors may influence outcomes. Furthermore, many prior studies have focused on postoperative endpoints, whereas preoperative functional improvement-as a modifiable, short-term goal-is less frequently studied despite its potential clinical and prognostic significance.
This prospective observational cohort study aims 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 SiPAP at Siriraj Hospital, Bangkok, Thailand, has incorporated this multimodal prehabilitation program as part of the standard of care within the Enhanced Recovery After Surgery (ERAS) protocol. The findings of this study will clarify the feasibility and clinical utility of implementing prehabilitation in Thai patients undergoing cancer surgery and may inform the design of future randomized controlled trials or support the development of evidence-based guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who enroll to Enhanced Recovery After Surgery (ERAS) program, Siriraj Hospital and referred to the SiPAP program.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Six-minute walk distance (6MWD)
Time frame: Preoperative period and postoperative period (1 and 3 months)
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)
3 secondary outcomes
Dominant handgrip strength
Time frame: Preoperative period and postoperative period (1 and 3 months)
Lower limb strength, balance, and functional mobility
Time frame: Preoperative period and postoperative period (1 and 3 months)
Functional capacity
Time frame: Preoperative period and postoperative period (1 and 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 27592691Bohannon 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.
- Background: PubMed 32213551Tew 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.
- Background: PubMed 27397681Moran 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.
- Background: PubMed 31188152Thomas 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.
- Background: PubMed 28489682Barberan-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.
- Background: PubMed 24439570Santa 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.
- Background: PubMed 23052535Li 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.
- Background: PubMed 21878237Mayo 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.
- Background: PubMed 30788536Hughes 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.
- Background: PubMed 25701926Carli 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wariya Vongchaiudomchoke, MD, MSc principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
An observational study of Prehabilitation and Functional Capacity, run by Siriraj Hospital.
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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Wariya Vongchaiudomchoke, MD, MSc (+66 85-920-9495, wariya.von@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk distance (6MWD) (time frame: Preoperative period and postoperative period (1 and 3 months)). 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 NCT07456943, which also lists 10 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 28 Apr 2026.