Patient-centered REhabilitation Program to Advance REcovery

ConditionsCancer Frailty Prehabilitation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19+

SponsorKorea University Anam Hospital

About this trial

The goal of this clinical trial is to learn whether an app-based, patient-centered prehabilitation program improves preoperative functional capacity in adults scheduled for elective cancer surgery. The main questions it aims to answer are:

Does the program increase the six-minute walk distance (6MWD) measured on the preoperative day (within 24-48 hours before surgery)?

Compared with usual care, does the program improve preoperative adherence to home 6MWT practice and patient-reported anxiety/depression (HADS)?

Researchers will compare an app-based prehabilitation program to usual care to see if the program improves preoperative functional capacity.

Participants will:

Use a study app to perform weekly home six-minute walk tests (6MWT) and complete brief daily check-ins (exercise, nutrition, psychological status) before surgery.

Attend routine preoperative admission (no extra visit) for in-hospital 6MWT (primary endpoint) and brief assessments (grip strength, Timed Up \& Go, HADS, skeletal muscle mass by InBody where available/fee-free).

Attend one routine postoperative outpatient visit at 3 or 6 months (site-standard timing) for follow-up assessments.

No additional study-specific clinic visits are required outside usual care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years.

Elective cancer surgery planned under general anesthesia at a participating site (e.g., gastrointestinal, hepatobiliary-pancreatic, thoracic, gynecologic, or other site-approved cancer operations).

Ambulatory: able to walk independently (assistive device such as a cane is allowed) and deemed safe to perform a six-minute walk test (6MWT) per investigator judgment.

Smartphone access and app use: owns/has regular access to a smartphone capable of running the study app and agrees to use the app (notifications, weekly home 6MWT logging, brief daily check-ins).

Disqualifiers

Emergency surgery or surgery date that cannot accommodate even minimal prehabilitation onboarding.

ASA IV or higher, or any unstable/critical condition that, in the investigator's opinion, makes participation unsafe.

Contraindications to 6MWT/light walking, including but not limited to: unstable angina, recent myocardial infarction (≤30 days), decompensated heart failure, uncontrolled clinically significant arrhythmia, severe symptomatic aortic stenosis, severe uncontrolled pulmonary disease, or investigator-judged safety concerns (e.g., resting severe hypoxemia, high fall risk).

Non-ambulatory status or musculoskeletal/neurologic conditions that preclude performing a 6MWT.

Trial design

Design model

Parallel

Treatments tested in this trial

App-based prehabilitation program
Behavioral
A lightweight mobile/web application delivering a patient-centered prehabilitation program from randomization until surgery. Features include: weekly home six-minute walk tests (6MWT) logged in the app; brief daily check-ins for exercise performed, simple nutrition targets, and mood/stress; push reminders; short educational video/handout content; and CSV export for analysis. The app provides standardized instructions and safety prompts for the home 6MWT and basic validity checks (continuous 6 minutes, pause limits, outlier flags). No additional study-specific clinic visits are required beyond routine preoperative admission and one routine postoperative outpatient visit.
Usual care (ERAS-standard perioperative care)
Other intervention
Standard perioperative counseling/education and routine mobilization per institutional ERAS practice. No study app is provided and no remote 6MWT logging is required. Outcome assessments are collected at routine preoperative admission (including in-hospital 6MWT per protocol) and at one routine postoperative outpatient visit (≈3 or 6 months per unified site policy). No additional study-specific clinic visits are required.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: RH groupExperimental treatment 1 intervention

Group B: UC groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Six-Minute Walk Distance (6MWD)

Distance in meters covered during a standardized six-minute walk test (6MWT) performed in hospital on the preoperative day. Testing follows ATS-aligned instructions on a marked indoor course (\~30 m). Trained staff administer the test and are blinded to group allocation when feasible. The primary endpoint is the absolute distance (meters) on the preoperative day; baseline/home 6MWT collected via the app may be used as a covariate but is not part of the primary measure. Safety prompts (stop for chest pain, severe dyspnea, presyncope) are embedded in the SOP.

Time frame