CEEEC-II: a 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity

CEEEC‐II is the prospective, open‐label extension of the CEEEC Phase I 2×2 factorialcluster‐randomized trial (NCT06975501). The extension is conducted in 32 community healthservice stations in Kunshan, Jiangsu Province, China. Up to 420 participants whocompleted the Phase I endpoint assessment will be approached consecutively. The estimatedPhase II enrollment is 356 participants, with a target of at least 320 participantscompleting the primary endpoint assessment. All participants will undergo a neweligibility review and provide written informed consent specifically for CEEEC‐II.No new randomization will occur. Each participating community health service station willretain its Phase I cluster assignment: physical and nutrition enrichment only, AI‐enabledcognitive enrichment only, combined physical, nutrition, and cognitive enrichment, orusual community‐based care. This preserves the original 2×2 factorial structure whilerecognizing that the Phase II cohort is a selectively re‐consented extension cohortrather than a newly randomized sample.Each participant will receive 12 weeks of the intervention assigned to the communitycluster. The active program comprises eight physician‐led Vitality Camp sessions and fourvolunteer‐led reinforcement activities. The upgraded physical and nutrition componentintegrates age‐appropriate aerobic, resistance, balance, and flexibility exercises,incorporates Baduanjin‐based movements, and provides practical nutrition education. Theupgraded cognitive component combines health education with age‐adapted, AI‐enabledlarge‐screen interactive games designed to engage memory, attention, processing speed,visuospatial ability, and executive function. Reinforcement activities and take‐homematerials support continued participation and practice between group sessions.Participants in the usual‐care arm continue routine community‐based stroke and chronicdisease management without the structured Phase II physical or cognitive enrichmentprogram.Assessments will be conducted at baseline and approximately 12 weeks after interventioninitiation. The primary outcome is an intrinsic capacity composite score derived fromcognition, locomotion, vitality, and psychological capacity domains. The primary estimandis the marginal effect of the cognitive enrichment factor. The physical enrichment factoreffect is a key secondary estimand. Cognitive function measured with the MontrealCognitive Assessment is retained as a secondary outcome in continuity with Phase I. Otherprespecified outcomes include MemTrax performance, physical function, nutritional status,depressive symptoms, blood pressure, health‐related quality of life, medicationadherence, physical activity, activities of daily living, falls, hospitalization, andrecurrent stroke. Analyses will account for community‐level clustering and the originalfactorial assignment.