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 — BEHAVIORALA 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) — OTHERStandard 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 groupParticipants 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 groupParticipants 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
- Eunji Ko, M.D., Ph.D.+82-10-3423-8249
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