An interventional study of Resistance Training Prehabilitation and Aerobic Training Prehabilitation in Colorectal Cancer, Colorectal Neoplasms and Postoperative Complications, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Semmelweis University · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to learn which type of exercise before surgery best reduces complications after colorectal surgery in adults with colorectal cancer or precancerous lesions. The main questions it aims to answer are:
Researchers will compare three exercise groups with a control group that receives standard care without an exercise program.
Participants will:
Background: Prehabilitation, i.e. preparing patients physically, nutritionally and mentally in the weeks before surgery, consistently improves preoperative functional capacity, but its effect on postoperative morbidity after colorectal surgery remains uncertain, especially when compared with Enhanced Recovery After Surgery (ERAS) care. Possible reasons include the lack of a standardized exercise protocol, the unknown optimal type of training, the unidentified patient subgroup most likely to benefit, and heterogeneous patient compliance in largely unsupervised, outpatient programs. In our preclinical study in a rat model, resistance training was associated with better colonic anastomosis healing than aerobic training; no human comparative trial has addressed this question.
Objectives: (1) To compare the effect of resistance training, aerobic endurance training and their combination, delivered within a trimodal prehabilitation program, on postoperative morbidity after elective colorectal resection; (2) to identify, by subgroup analysis, patients most likely to benefit from physical prehabilitation; (3) to assess factors influencing patient compliance and the association between compliance and outcomes.
Design: Single-center, prospective, randomized, controlled, parallel-group trial with four arms (1:1:1:1). Allocation is performed automatically by software randomization embedded in REDCap at enrollment and cannot be modified. Personnel recording outcome data are blinded to group allocation. The trial follows CONSORT recommendations.
Standard care in all arms: dietitian-led nutritional prehabilitation with oral nutritional supplements when indicated; screening for anxiety and depression (BDI, PHQ-9, STAI) with clinical psychologist consultation for high-risk patients; breathing exercises and incentive spirometry training; nurse-led ERAS education, stoma education when indicated, and counseling on smoking and alcohol cessation. Perioperative care follows an audited ERAS program with >80% protocol compliance.
Assessments: baseline nutritional (MUST, InBody), physical (6-minute walk test, 1-minute sit-to-stand test, handgrip strength, frailty scores: CFS, mFI-5, FRAIL), psychological and quality-of-life (SF-36, GIQLI) assessment; CT-based body composition (L3 skeletal muscle index, myosteatosis). Compliance is monitored through a patient diary, weekly physiotherapy visits or phone calls, and daily pulse-wave recordings. Assessments are repeated on the day before surgery and 8 weeks after surgery. Complications are recorded according to the Clavien-Dindo classification. Long-term oncological outcomes are followed up within a separate institutional registry study.
Statistics: Sample size of 120 patients per arm (480 total) was calculated for an expected reduction in postoperative morbidity from 30% to 15% (alpha 0.05, power 80%). An interim analysis is planned after 30 patients per arm to assess the ethical continuation of the trial. Each experimental arm will be compared with the control arm, followed by pairwise comparisons between experimental arms with adjustment for multiple comparisons. Classification and Regression Tree (CART) analysis will be used to identify the subgroup most likely to benefit from prehabilitation.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 480 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Home-based resistance training for 4-6 weeks before surgery, in addition to standard trimodal care. Mon/Wed/Fri: seated knee extensions (2×20/day), standing knee raises (2×20/day), calf raises (2×/day), chair-supported squats (2×10/day). Tue/Thu/Sat: biceps curls, lateral raises and front raises with 0.5-1 L water bottles (3×10/day each). Sunday: rest. Weekly physiotherapy check-up in person or by phone.
Behavioral: Resistance Training Prehabilitation · Other: Standard Trimodal Care
Home-based aerobic endurance training for 4-6 weeks before surgery, in addition to standard trimodal care: brisk walking or cycling for 15 minutes twice daily at a target heart rate of approximately 100/min (modified Borg scale 5-6). Weekly physiotherapy check-up in person or by phone.
Behavioral: Aerobic Training Prehabilitation · Other: Standard Trimodal Care
Combination of the resistance and aerobic training programs for 4-6 weeks before surgery, in addition to standard trimodal care, with chair-supported squats 4×5 repetitions daily. Weekly physiotherapy check-up in person or by phone.
Behavioral: Resistance Training Prehabilitation · Behavioral: Aerobic Training Prehabilitation · Other: Standard Trimodal Care
Standard trimodal care without physical exercise prehabilitation: nutritional prehabilitation, psychological support if needed, breathing exercises with incentive spirometry, and ERAS perioperative care.
Other: Standard Trimodal Care
Structured home-based resistance exercise program performed for 4-6 weeks before colorectal surgery, supervised weekly by a physiotherapist.
Home-based aerobic exercise (brisk walking or cycling, 2×15 min/day at moderate intensity) performed for 4-6 weeks before colorectal surgery, supervised weekly by a physiotherapist.
Dietitian-led nutritional prehabilitation with oral nutritional supplements when indicated, psychological screening and clinical psychologist support for high-risk patients, breathing exercises with incentive spirometry, and ERAS-based perioperative care.
Postoperative Morbidity Within 30 Days
Proportion of participants with any postoperative complication within 30 days after surgery. Complications are graded according to the Clavien-Dindo classification (grade I-V), and the severity distribution will also be reported.
Time frame: From surgery to postoperative day 30
Early Postoperative Morbidity Within 7 Days
Proportion of participants with any postoperative complication within 7 days after surgery, graded according to the Clavien-Dindo classification (grade I-V).
Time frame: From surgery to postoperative day 7
Postoperative Mortality
All-cause mortality within 7 and 30 days after surgery.
Time frame: Postoperative day 7 and day 30
Change in 6-Minute Walk Distance
Distance walked in 6 minutes (meters), measured by the 6-minute walk test.
Time frame: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery
Change in Handgrip Strength
Maximal handgrip strength (kg) measured with a hand dynamometer.
Time frame: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery
Change in 1-Minute Sit-to-Stand Test
Number of sit-to-stand repetitions completed in 1 minute.
Time frame: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery
Change in Health-Related Quality of Life (SF-36)
36-Item Short Form Survey; scores range from 0 to 100, higher scores indicate better health status.
Time frame: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery
Change in Gastrointestinal Quality of Life (GIQLI)
Gastrointestinal Quality of Life Index; total score ranges from 0 to 144, higher scores indicate better quality of life.
Time frame: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery
Length of Hospital Stay
Number of days from surgery to hospital discharge.
Time frame: From surgery to discharge, up to 30 days
Length of Intensive Care Unit Stay
Number of days spent in the intensive care unit after surgery, excluding high dependency unit stay.
Time frame: From surgery to discharge, up to 30 days
Compliance With the Prehabilitation Program
Proportion of prescribed prehabilitation tasks completed (physical exercise, incentive spirometry, oral nutritional supplements, smoking and alcohol cessation), based on the patient diary and weekly follow-up; association of compliance with postoperative morbidity.
Time frame: From enrollment to the day before surgery (4-6 weeks)
Plan to share: No — Individual participant data will not be shared. Aggregated results will be published in peer-reviewed journals.
Started May 2026 (actual). Primary completion is estimated for Mar 2028, 22 months after the start.
Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 22 months is below that.
Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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