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

Sponsor
The Affiliated Hospital of Qingdao University
Study ID
NCT07764523
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
    Participants allocated to the intervention group will receive a whole-course, remotely supervised, home-based multimodal prehabilitation programme delivered through a 5G- and artificial intelligence (AI)-enabled digital health platform. The multimodal prehabilitation included physical and respiratory training, nutritional support, and psychosocial treatment. Our center's prehabilitation experts, clinical nutritionists, psychiatrists, surgeons, nurses and oncologists will collaboratively assess and develop prehabilitation plans. The prehabilitation group received a mobile mini-app that provided an exercise program, dietary advice and psychological assessment and intervention. The management of prehabilitation 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.
  • ERAS group — BEHAVIORAL
    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 whole course management of gastric caner patients receiving neoadjuvant therapy frequently hinders by challenges such as inaccurate exercise plans, inadequate nutritional supplementary, limited access to timely psychological support, the toxicity of chemtherapy and poor adherence to prehabilitation protocols. AI (Agent Intelligence) have already been demonstrated remarkable capabilities in personalized patient education and improving compliance to perhabilitation protocols. To date, high quality evidence from randomized clinical trials investigating the clinical and oncological benefit of prehabilitation based on 5G+AI mobile health for this patient cohort is lacking.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
May 30, 2028
Completion
May 30, 2030

Study Design

Enrollment
328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: prehabilitation group
    The prehabilitation group will receive 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

Comprehensive complication index (CCI) [ Time Frame: postoperative 30 days ]

Central Contacts

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