Telerehabilitation in Cancer Patients: Optimization of Prehabilitation and Rehabilitation Following Colorectal Resection

NCT ID: NCT06593678

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2026-07-31

Brief Summary

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.

Detailed Description

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-four 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.

Conditions

Colorectal Cancer; Telerehabilitation; Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group. Asynchronous telerehabilitation

Receive a home-based rehabilitation program via an asynchronous digital telerehabilitation platform.

Group Type: EXPERIMENTAL

Telerehabilitation Program

Intervention Type: OTHER

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.

Control Group. Booklet-based rehabilitation

Receive a booklet-based rehabilitation program at home through a detailed printed guide (explanatory booklet).

Group Type: ACTIVE_COMPARATOR

Booklet-based rehabilitation program

Intervention Type: OTHER

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.

Interventions

Telerehabilitation 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.

Intervention Type: OTHER

Booklet-based rehabilitation program

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.

Intervention Type: OTHER

Other Intervention Names

Asynchronous Digital Rehabilitation; Printed Guide Rehabilitation

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 80 years.
• Participants who understand Spanish.
• Patients scheduled for colorectal cancer surgery at Royo Villanova Hospital, Zaragoza, Spain.
• Patients attending the first consultation in the General and Digestive Surgery Section under the supervision of Dr. Blas, head of surgery at Royo Villanova Hospital, Zaragoza, Spain.
• Participants with functional independence that allows them to perform walking and pulmonary function tests.
• Patients with a preoperative assessment score of I, II, or III on the American Society of Anesthesiologists (ASA) scale.
• Participants who agree to participate and sign the informed consent form.

Exclusion Criteria

• Patients older than 80 years.
• Patients with a preoperative ASA score of IV.
• Patients with any injury, pathology, or inflammatory processes that make it impossible to practice exercise.
• Patients with central and/or peripheral neurological diseases that prevent them from following the rehabilitation program.
• Patients with unstable cardiac comorbidities such as arrhythmias, high blood pressure, angina pectoris, or other conditions that contraindicate moderate-intensity training.
• Patients diagnosed with a psychiatric disorder as confirmed by a psychiatrist.
• Patients without access to mobile internet or a computer with internet at home.
• Patients who score ≤ 24 on the Mini-Mental State Examination (MMSE).
• Individuals who are unable to follow oral and written instructions in Spanish.
• Patients who refuse to participate in the study or who have not signed the informed consent form.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: collaborator

Universidad San Jorge

OTHER

Sponsor Role: collaborator

Hospital Royo Villanova de Zaragoza

UNKNOWN

Sponsor Role: collaborator

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role: lead

Responsible Party

Sandra Calvo Carrión

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Calvo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Zaragoza

Locations

Hospital Royo Villanova

Zaragoza, Zaragoza, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

José Manuel Burgos Bragado, MSc

Role: CONTACT

jmburgos@usj.es

+34 646 207 142

Sandra Calvo, PhD

Role: CONTACT

sandracalvo@unizar.es

+34 661 833 194

Facility Contacts

José Manuel Burgos Bragado, MSc

Role: primary

jmburgos@usj.es

+34 646207142

Other Identifiers

UZ-USJ-CCR

Identifier Type: -

Identifier Source: org_study_id