Preoperative Home-based Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health

Sponsor
The Affiliated Hospital of Qingdao University
Study ID
NCT07755917
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • mHealth prehabilitation group — BEHAVIORAL
    receiving at least 4 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management
  • ERAS group — OTHER
    The management of ERAS group was carried out in accordance with the standard ERAS protocol from admission until 30 days postdischarge. The ERAS program mainly included malnutrition screening, health education, surgical risk assessment, and smoking and drinking cessation.

Study Details

The goal of this prospective, multicenter, open-label randomized controlled clinical trial is to evaluate whether a home-based, digitally supervised multi-modal prehabilitation intervention can improve functional capacity, treatment tolerance, and short- and long-term clinical outcomes in gastric cancer patients who have completed 2-4 cycles of neoadjuvant chemotherapy and are scheduled for radical gastrectomy.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2030

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: prehabilitation group
    The prehabilitation group will receive preoperative multimodal prehabilitation combined with ERAS before gastrectomy.
  • Placebo Comparator: ERAS group
    The ERAS group patients will be managed according to the ERAS pathway.

Primary Outcome Measure

postoperative complications [ Time Frame: postoperative 30 days ]

Central Contacts

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