An interventional study of Telerehabilitation Program and Booklet-based rehabilitation program in Colorectal Cancer, Telerehabilitation and Physical Therapy, sponsored by Instituto de Investigación Sanitaria Aragón. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Instituto de Investigación Sanitaria Aragón · Not applicable, Interventional, and Treatment
This study, titled: Telerehabilitation in Oncology Patients: Optimization of Prehabilitation and Rehabilitation Post-Colorectal Resection. Is a randomized clinical trial conducted at the Royo Villanova Hospital in Zaragoza, Spain. It aims to evaluate the effectiveness of a tele-rehabilitation program in enhancing functional capacity and quality of life for patients undergoing colorectal cancer surgery. Colorectal cancer (CRC) is a highly prevalent malignant tumor that significantly impacts global health and patients\' quality of life, particularly after surgery. Prehabilitation and postoperative rehabilitation are crucial for recovery, and telerehabilitation offers a promising alternative to improve outcomes in CRC patients.
Study Background and Rationale: Colorectal cancer (CRC) is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths. Despite advancements in surgical and oncological treatments, patients often experience significant postoperative complications and a decline in their quality of life. Prehabilitation, which aims to enhance a patient's functional capacity before surgery, has been identified as a promising approach to improve postoperative outcomes. However, traditional rehabilitation programs are often limited by patient adherence, accessibility, and the availability of resources, especially for those living in rural or underserved areas.
Objective: The primary objective of this study is to determine whether a 2-week prehabilitation and 4-week post-surgical rehabilitation program delivered via asynchronous telerehabilitation software can improve the functional capacity of patients undergoing colorectal cancer surgery, as measured by the Six Minute Walking Test (6MWT). Secondary objectives include assessing changes in body composition, muscle strength, pulmonary capacity, postoperative complications, psychosocial factors (such as quality of life, anxiety, depression, and sleep quality), adherence to the treatment, patient acceptance of the treatment, and the usability of the telerehabilitation platform.
Study Design: This is a single-blind, parallel-group randomized clinical trial. Fifty-six patients scheduled for colorectal cancer surgery will be recruited and randomly assigned to either the control group, which will receive conventional rehabilitation through a booklet, or the intervention group, which will receive the same rehabilitation program through a digital telerehabilitation platform. Both groups will undergo a comprehensive rehabilitation program including therapeutic education, respiratory exercises, aerobic exercises, and strength training.
Methodology: Patients will be assessed at five time points: pre-intervention, the day before surgery, 21 days post-surgery, 50 days post-surgery, and 3-month follow-up. The telerehabilitation platform will allow patients to access exercise videos and therapeutic content asynchronously, with the ability to communicate with their physiotherapists through the platform for guidance and support. The booklet will allow patients to access the program through pictures and text.
Clinical implications: Telerehabilitation represents an innovative approach to overcoming barriers associated with conventional rehabilitation, particularly in improving accessibility for patients in remote areas. By demonstrating the clinical efficacy of telerehabilitation, this study aims to contribute to the optimization of rehabilitation protocols for oncology patients and to provide a scalable model for integrating digital health solutions into routine clinical practice.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 80 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Instituto de Investigación Sanitaria Aragón is the lead sponsor of 31 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Receive a home-based rehabilitation program via an asynchronous digital telerehabilitation platform.
Other: Telerehabilitation Program
Receive a booklet-based rehabilitation program at home through a detailed printed guide (explanatory booklet).
Other: Booklet-based rehabilitation program
Participants in the intervention group will receive a home-based rehabilitation program delivered via an asynchronous digital telerehabilitation platform. The multimodal program is accessible at online platform and it is composed for therapeutic exercises, including aerobic and strength training exercises, aimed at improving functional capacity and quality of life before and after colorectal cancer surgery.
Also known as: Asynchronous Digital Rehabilitation
Participants in the control group will receive a booklet-based rehabilitation program at home, provided through a detailed printed guide (explanatory booklet). This guide includes instructions in pictures and text for the multimodal program. It is composed for therapeutic exercises, including aerobic and strength training exercises, aimed at improving functional capacity and quality of life before and after colorectal cancer surgery.
Also known as: Printed Guide Rehabilitation
Functional Capacity - Six Minute Walking Test (6MWT)
The primary outcome is the improvement in functional capacity, which will be evaluated using the Six Minute Walking Test (6MWT). This test measures the maximum distance a patient can walk in six minutes along a flat, straight corridor under controlled conditions. The results provide an objective assessment of the patient\'s functional capacity, reflecting their ability to perform daily activities and their level of postoperative recovery.
Time frame: Functional capacity will be assessed at four time points: pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
Pulmonary Capacity - Spirometry Assessments
Evaluate improvements in pulmonary capacity using spirometry, with a specific focus on measuring Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) through standardized spirometry techniques.. The aim is to determine whether the tele-rehabilitation program can enhance respiratory function as compared to the standard approach.
Time frame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
Upper Limb Muscle Strength - Hand Grip Test
Evaluate the muscle strength of the upper limbs using the Hand Grip Test. This assessment will provide data on the effectiveness of the tele-rehabilitation program in enhancing upper limb muscle strength.
Time frame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
Lower Limb Muscle Strength - Sit to Stand Test
Evaluate the muscle strength of the lower limbs using the Sit to Stand Test. This assessment will provide data on the effectiveness of the tele-rehabilitation program in enhancing lower limb muscle strength.
Time frame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
Body Composition - Bioelectrical Impedance Analysis and Waist-to-Hip Ratio
Assess changes in body composition, including measurements taken via bioelectrical impedance analysis (BIA) and waist-to-hip ratio. This will help determine if the tele-rehabilitation program leads to significant improvements in body composition compared to the conventional rehabilitation program.
Time frame: Measured at pre-intervention (T1), the day before surgery (T2), 21 days post-surgery (T3), and 50 days post-surgery (T4).
Postoperative Complications - Comprehensive Complication Index (CCI)
Assess the occurrence and severity of postoperative complications using the Comprehensive Complication Index (CCI). The CCI provides a cumulative score that reflects the overall burden of all complications, ranging from 0 (no complications) to 100 (death). This outcome measure aims to determine whether the tele-rehabilitation program effectively reduces the rate and severity of postoperative complications compared to the standard rehabilitation approach.
Time frame: Evaluated 3 months post-surgery (T5).
Quality of Life - EuroQol-5D (EQ-5D)
Assess the impact on quality of life using the EuroQol-5D (EQ-5D) instrument. The EQ-5D evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores range from -0.594 to 1, where higher scores indicate better quality of life.
Time frame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS)
Measure levels of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of two subscales: anxiety and depression, each ranging from 0 to 21. Higher scores indicate worse outcomes.
Time frame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
Psychological Adjustment - Mental Adjustment to Cancer Scale (MAC)
Evaluate psychological adjustment to cancer using the Mental Adjustment to Cancer Scale (MAC). The MAC includes subscales such as fighting spirit, helplessness/hopelessness, anxious preoccupation, fatalism, and avoidance. Scores vary by subscale, generally ranging from 0 to 32 for each subscale. Higher scores on positive subscales, such as fighting spirit, indicate better adjustment, while higher scores on negative subscales, such as helplessness/hopelessness, indicate worse adjustment.
Time frame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
Sleep Quality - Pittsburgh Sleep Quality Index (PSQI)
Assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI). The PSQI measures seven components: sleep duration, sleep disturbances, sleep latency, daytime dysfunction, and more. Scores range from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Assessed at pre-intervention (T1), 50 days post-surgery (T4) and 3 months post-surgery (T5).
Adherence to the Tele-Rehabilitation Program
Evaluate compliance with the tele-rehabilitation protocol by tracking the percentage of prescribed sessions completed by participants. Compliance data will be recorded in treatment diaries and through the tele-rehabilitation platform. The compliance rate will be calculated as the proportion of completed sessions out of the total prescribed sessions.
Time frame: Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).
Satisfaction with Tele-Rehabilitation Program
Assess participant satisfaction with the tele-rehabilitation program using a standardized satisfaction survey. The survey will be recorded on the tele-rehabilitation platform, and scores will range from 1 to 4, with higher scores indicating greater satisfaction.
Time frame: Monitored continuously throughout pre-intervention (T1) - the day before surgery (T2), 21 days post-surgery (T3) - 50 days post-surgery (T4).
Incremental Cost-Effectiveness Ratio (ICER) - Cost per QALY
Assess the cost-effectiveness of the tele-rehabilitation program compared to conventional clinical practice by calculating the Incremental Cost-Effectiveness Ratio (ICER). The ICER is expressed in euros per Quality-Adjusted Life Year (QALY). This measure will provide insight into the additional cost per QALY gained with the tele-rehabilitation program.
Time frame: Evaluated after 3 months post-surgery (T5).
Quality-Adjusted Life Years (QALYs)
Evaluate the quality-adjusted life years (QALYs) gained through the tele-rehabilitation program compared to conventional clinical practice. The QALY is a measure of the value of health outcomes, combining both quantity and quality of life. Scores typically range from 0 (equivalent to death) to 1 (perfect health), with higher scores indicating better outcomes.
Time frame: Evaluated after 3 months post-surgery (T5).
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 ↗
This study is completed, as verified in Sep 2025. 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.
Instituto de Investigación Sanitaria Aragón