An interventional study of Strength training program in Locally Advanced Rectal Cancer, sponsored by Fundacion Arturo Lopez Perez. Not yet recruiting at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by Fundacion Arturo Lopez Perez · Not applicable, Interventional, and Supportive care
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.
Eligible patients with locally advanced rectal adenocarcinoma treated at FALP and scheduled for RAPIDO total neoadjuvant therapy will be invited during routine visits.
Participants receive usual oncologic care plus a supervised, individualized resistance training program performed in the FALP Kinesiology Service gym. Each session lasts 60 minutes, twice weekly, from the start of neoadjuvant therapy to surgery (24 weeks).
Training loads are prescribed from baseline strength testing and progressed every 2 weeks; an intermediate clinical-functional assessment around week 8 supports safe adjustment. Assessments occur at baseline and within 48 hours before surgery. Data will be stored in REDCap.
Fundacion Arturo Lopez Perez is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive supervised, individualized progressive resistance training twice weekly (60 minutes/session) from start of neoadjuvant therapy until surgery (24 weeks).
Other: Strength training program
Individualized 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.
Time frame: During the recruitment period
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.
Time frame: From enrollment through end of intervention (~24 weeks)
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%
Time frame: From enrollment through end of intervention (~24 weeks)
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.
Time frame: From enrollment through end of intervention (~24 weeks)
Data completeness (completed scheduled assessments among planned assessments) (%)
Data completeness will be calculated as: (number of completed scheduled assessments ÷ number of planned assessments) × 100. The feasibility threshold is ≥85% of scheduled assessments completed.
Time frame: From enrollment through end of intervention (~24 weeks)
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.
Time frame: From enrollment through end of intervention (24 weeks)
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.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
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.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
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.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
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)
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Change from baseline in cancer-related fatigue assessed by Brief Fatigue Inventory (BFI) score (0-10)
Fatigue will be measured using the Brief Fatigue Inventory (BFI). Scores range from 0 to 10. Change from baseline will be analyzed.
Time frame: Baseline and within 48 hours prior to rectal surgery (~24 weeks)
Participant satisfaction with the exercise program assessed by CSQ-8 total score (8-32)
Satisfaction will be assessed using the Client Satisfaction Questionnaire (CSQ-8) at the end of the intervention.Unit of Measure: Score (8-32)
Time frame: End of intervention (prior to surgery; ~24 weeks)
Plan to share: Yes — Recruitment rate, Mean Adherence and Safety profile
Supporting information: Study protocol
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fundacion Arturo Lopez Perez