Colorectal cancer is a major cause of cancer death in Chile. Many people with rectal cancer that has grown into nearby tissues receive chemotherapy and radiation before surgery. These treatments can cause tiredness and loss of muscle, which may make it harder for patients to complete treatment.
This study will look at whether a supervised strength-training exercise program is practical and safe during treatment before surgery. Participants will do a personalized strength-training program two times per week. The program will start when cancer treatment begins and will continue until surgery (about 24 weeks).
The study will measure how practical the program is by looking at how many people join the study, stay in the study, and attend the exercise sessions, and whether the study team can collect all planned information. The study will also track any problems or side effects related to exercise.
The study will also explore whether the exercise program may help maintain muscle, improve strength and physical function, improve quality of life, reduce fatigue, and affect how the tumor responds to treatment. These results will be compared with information from similar patients previously treated at the same hospital.
Locally advanced rectal adenocarcinoma planned for RAPIDO total neoadjuvant therapy (short-course RT + chemotherapy + surgery), meeting protocol staging criteria (e.g., cT3N1/cT4/cN2/EMVI+/threatened mesorectal fascia/lateral pelvic disease).
Metastatic disease at diagnosis.
Severe/uncontrolled cardiovascular disease (ejection fraction <50%).
Single group
Strength training program
Other interventionIndividualized supervised progressive resistance training twice weekly (60 minutes/session) from start of neoadjuvant therapy to surgery (24 weeks), with loads prescribed from baseline strength testing and progressed every 2 weeks; safety monitored and adapted based on clinical status.
Recruitment rate (enrolled among eligible patients) (%)
Primary Outcome Measure 1 - Recruitment Recruitment will be calculated as: (number of eligible patients who enroll ÷ number of eligible patients approached) × 100. The feasibility threshold is ≥60% of eligible patients agreeing to participate.
Retention rate (participants completing the intervention) (%)
Description: Retention will be calculated as: (number of enrolled participants who complete the intervention ÷ number enrolled) × 100. The feasibility threshold is ≥80% completing the intervention.
Mean adherence to planned supervised resistance-training sessions (%)
Adherence (individual-level) will be calculated as: (number of supervised sessions completed ÷ number of planned sessions) × 100. Study-level adherence will be reported as the mean of individual adherence percentages across all enrolled participants. Planned dose: 2 supervised sessions/week from start of neoadjuvant therapy until surgery (\~24 weeks; total 48 sessions). The feasibility threshold is mean adherence ≥80%
Participants completing ≥80% of planned supervised sessions (%)
A participant will be considered adherent if they complete ≥80% of planned supervised sessions (≥39 of 48 sessions). The proportion of participants meeting this threshold will be calculated. The feasibility threshold is ≥75% of participants completing ≥80% of planned sessions.
Participants with ≥1 exercise-related adverse event (CTCAE v6.0) (%)
Safety will be assessed as the proportion of participants experiencing ≥1 exercise-related adverse event during the intervention period. Exercise-related adverse events will be classified and graded using CTCAE v6.0.
Change from baseline in cross-sectional skeletal muscle area at L3 measured by CT (cm²)
Description: Cross-sectional muscle area (CSA) at lumbar level L3 will be quantified using routine CT (thorax-abdomen-pelvis) at baseline and pre-surgery. Change from baseline will be analyzed.
Change from baseline in handgrip strength measured by dynamometer (kg)
Handgrip strength will be measured using a handgrip dynamometer at baseline and post-prehabilitation. Change from baseline will be analyzed.
Change from baseline in Short Physical Performance Battery (SPPB) score (points)
Physical performance will be measured using the Short Physical Performance Battery (SPPB). Change from baseline will be analyzed.
Change from baseline in quality of life assessed by EORTC QLQ-C30 score (0-100)
Quality of life will be measured using the EORTC QLQ-C30 questionnaire. Scores range from 0 to 100. Change from baseline will be analyzed.Unit of Measure: Score (0-100)
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