Patient-centered REhabilitation Program to Advance REcovery

Sponsor
Korea University Anam Hospital
Study ID
NCT07189000
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Frailty
  • Prehabilitation

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

First listed
Sep 23, 2025
Start date
Jan 1, 2026
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: RH group
    Participants receive an app-based, patient-centered prehabilitation program from randomization until surgery (no extra clinic visits). The program includes weekly home six-minute walk tests (6MWT) logged in the app, brief daily check-ins (exercise performed, simple nutrition targets, mood/stress), push reminders, and short educational video/handout content. Safety prompts and validity checks (continuous 6 minutes, pause limits, outlier flags) are embedded in the app. All on-site assessments are aligned with routine care: preoperative-day in-hospital testing (primary 6MWD, plus grip/TUG/HADS; InBody via fee-free pathway where available) and one routine postoperative outpatient visit (3 or 6 months; site-standard) for follow-up secondary measures. Usual perioperative care is provided per site ERAS practice.
  • Active Comparator: UC group
    Participants receive standard perioperative care per each site's ERAS-consistent routine (preoperative counseling/education, routine mobilization). No study app is provided and no remote 6MWT logging is required. For outcomes collection only, participants undergo the same preoperative-day in-hospital assessment (primary 6MWD, plus grip/TUG/HADS; InBody via fee-free pathway where available) and one routine postoperative outpatient visit (3 or 6 months; site-standard). No additional study-specific clinic visits are required.

Primary Outcome Measure

Six-Minute Walk Distance (6MWD) [ Time Frame: Preoperative day (within 24-48 hours before surgery) ]

Central Contacts

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