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Colorectal CancerNCT07896174

Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery

A study testing Resistance Training Prehabilitation, Aerobic Training Prehabilitation and Standard Trimodal Care in people with Colorectal Cancer and Colorectal Neoplasms, run by Semmelweis University at 1 site in Hungary.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resistance Training Prehabilitation, Aerobic Training Prehabilitation and Standard Trimodal Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
1 siteHungary
Study dates
27 May 2026to Mar 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years
  • Elective, curative-intent colon or rectal resection
  • Malignant or premalignant colorectal lesion
  • Signed written informed consent after receiving study information

Who cannot join

  • Refusal to participate in the study
  • Comorbidities precluding physical prehabilitation
  • Physical, neurological or mental status precluding physical prehabilitation
  • Unplanned acute surgery required during the prehabilitation period
  • Transanal minimally invasive surgery (TAMIS)
  • Palliative surgery only
  • Pregnancy
  • Preoperative preparation program deviating from the study protocol, as deemed necessary by the study team

Trial locations and contacts

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

Balazs Banky, MD, PhD contact

+36208258915

banky.balazs@semmelweis.hu

Hungary1 site, 1 recruiting
  • Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

    Budapest, 1082

    Balazs Banky, MD, PhD, +36208258915, banky.balazs@semmelweis.hu

    Recruiting

Other trials in Hungary

About this study

Official title: Effect of Preoperative Resistance and Aerobic Endurance Training on Surgical Outcomes and Evaluation of Patient Compliance With Prehabilitation in Colorectal Surgery: A Randomized Controlled Trial

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:

  • Does resistance (strength) training, aerobic (endurance) training, or a combination of both before surgery lower the rate and severity of complications in the first 30 days after surgery, compared with no exercise program?
  • Which factors influence how well patients follow a prehabilitation program, and does following the program affect surgical outcomes?
Read more

Researchers will compare three exercise groups with a control group that receives standard care without an exercise program.

Participants will:

  • Be randomly assigned to one of four groups: resistance training, aerobic training, combined training, or no exercise program (control)
  • Do the assigned home exercise program for 4 to 6 weeks before surgery, with weekly physiotherapy check-ups in person or by phone
  • Receive nutritional counseling, breathing exercises, and psychological support if needed, regardless of group
  • Keep a daily exercise diary and record their pulse daily
  • Undergo physical fitness tests (walking test, sit-to-stand test, handgrip strength) and quality-of-life questionnaires before surgery and 8 weeks after surgery
Read the detailed description

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.

Being tested
Resistance Training Prehabilitation, Aerobic Training Prehabilitation, Standard Trimodal Care
Keywords
Prehabilitation, Resistance Training, Aerobic Exercise, Preoperative Exercise, Enhanced Recovery After Surgery, Patient Compliance, Frailty, Sarcopenia
Medical subject headings
Colorectal Neoplasms, Postoperative Complications, Patient Compliance, Frailty, Sarcopenia

What participants receive

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

  • Resistance Training PrehabilitationBehavioural

    Structured home-based resistance exercise program performed for 4-6 weeks before colorectal surgery, supervised weekly by a physiotherapist.

  • Aerobic Training PrehabilitationBehavioural

    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.

  • Standard Trimodal CareOther

    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.

Study groups in NCT07896174
Study groupRoleWhat they receive
Resistance TrainingExperimentalHome-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.
Receives: Behavioral: Resistance Training Prehabilitation; Other: Standard Trimodal Care
Aerobic TrainingExperimentalHome-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.
Receives: Behavioral: Aerobic Training Prehabilitation; Other: Standard Trimodal Care
Combined Resistance and Aerobic TrainingExperimentalCombination 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.
Receives: Behavioral: Resistance Training Prehabilitation; Behavioral: Aerobic Training Prehabilitation; Other: Standard Trimodal Care
Standard of Care (Control)Active comparatorStandard trimodal care without physical exercise prehabilitation: nutritional prehabilitation, psychological support if needed, breathing exercises with incentive spirometry, and ERAS perioperative care.
Receives: Other: Standard Trimodal Care

What is being measured

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

  1. 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.

    Measured: From surgery to postoperative day 30

  2. 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).

    Measured: From surgery to postoperative day 7

Secondary outcomes (8)
  1. Postoperative Mortality

    All-cause mortality within 7 and 30 days after surgery.

    Measured: Postoperative day 7 and day 30

  2. Change in 6-Minute Walk Distance

    Distance walked in 6 minutes (meters), measured by the 6-minute walk test.

    Measured: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery

  3. Change in Handgrip Strength

    Maximal handgrip strength (kg) measured with a hand dynamometer.

    Measured: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery

  4. Change in 1-Minute Sit-to-Stand Test

    Number of sit-to-stand repetitions completed in 1 minute.

    Measured: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery

  5. 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.

    Measured: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery

  6. 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.

    Measured: At enrollment, the day before surgery (after 4-6 weeks of prehabilitation), and 8 weeks after surgery

  7. Length of Hospital Stay

    Number of days from surgery to hospital discharge.

    Measured: From surgery to discharge, up to 30 days

  8. Length of Intensive Care Unit Stay

    Number of days spent in the intensive care unit after surgery, excluding high dependency unit stay.

    Measured: From surgery to discharge, up to 30 days

Timeline

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

  1. First posted26 Oct 2026
  2. Study start27 May 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Four-arm parallel-group design with 1:1:1:1 allocation: resistance training, aerobic training, combined resistance and aerobic training, or standard care without physical prehabilitation. All arms receive standardized nutritional, psychological and respiratory prehabilitation and ERAS perioperative care.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896174
Sponsor's protocol ID
NNGYK/02258-7/2026
Other IDs
BM/5143-3/2026, 1128
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Aggregated results will be published in peer-reviewed journals.

Publications

  • Levay K, Kovacs S, Budai A, Horvath I, Kovacs N, Mathe D, Szigeti K, Dunai Z, Makra N, Juhasz J, Ostorhazi E, Banky B, Szijarto A, Fulop A. Physical prehabilitation improves colonic anastomosis healing in a malnourished rat model only if attached to effective nutritional prehabilitation - Experimental study. Surgery. 2025 Dec;188:109677. doi: 10.1016/j.surg.2025.109677. Epub 2025 Sep 18.

    PubMed 40972191
  • Fulop A, Lakatos L, Susztak N, Szijarto A, Banky B. The effect of trimodal prehabilitation on the physical and psychological health of patients undergoing colorectal surgery: a randomised clinical trial. Anaesthesia. 2021 Jan;76(1):82-90. doi: 10.1111/anae.15215. Epub 2020 Aug 6.

    PubMed 32761611

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Training Prehabilitation, Aerobic Training Prehabilitation and Standard Trimodal Care in people with Colorectal Cancer and Colorectal Neoplasms, run by Semmelweis University at 1 site in Hungary.

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 8 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 26 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 Hungary. 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 Balazs Banky, MD, PhD (+36208258915, banky.balazs@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Morbidity Within 30 Days (time frame: From surgery to postoperative day 30). 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 NCT07896174, which also lists 2 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 26 Oct 2026.

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