CEEEC-II: A 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity
NCT07778771 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 365
Last updated 2026-08-21
Summary
CEEEC-II is a 12-week, community-based, prospective extension study conducted in 32 community health service stations in Kunshan, China. It will invite older stroke survivors with hypertension and/or type 2 diabetes who participated in the preceding CEEEC Phase I trial (NCT06975501) to provide new informed consent and complete Phase II eligibility and baseline assessments. Participants will remain in the physical enrichment, cognitive enrichment, combined enrichment, or usual-care arm assigned to their community cluster in Phase I; no new randomization will occur in CEEEC-II. The upgraded program includes eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. The physical component integrates aerobic, resistance, balance, flexibility, Baduanjin, and nutrition education. The cognitive component integrates health education with age-adapted games delivered through an AI-enabled interactive large screen. The primary objective is to evaluate the marginal effect of the cognitive enrichment factor on intrinsic capacity at 12 weeks.
Conditions
- Stroke
- Hypertension
- Type 2 Diabetes Mellitus (T2DM)
- Multimorbidity
Interventions
- BEHAVIORAL
-
Physical Enrichment
A 12-week community-based program delivered through eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. Content includes age-appropriate aerobic, resistance, balance, and flexibility exercises, Baduanjin-based movements, practical nutrition education, and supported practice between sessions.
- BEHAVIORAL
-
Cognitive Enrichment
A 12-week community-based program delivered through eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. Health education is combined with age-adapted games presented on an AI-enabled interactive large screen to engage memory, attention, processing speed, visuospatial ability, and executive function, with supported practice between sessions.
Sponsors & Collaborators
-
Beijing Tiantan Hospital
collaborator OTHER -
Kunshan Hospital of Traditional Chinese Medicine
collaborator OTHER -
Shanghai Jiao Tong University School of Medicine
collaborator OTHER -
Duke Kunshan University
lead OTHER
Principal Investigators
-
Lijing Yan, Professor · Duke Kunshan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-01-03
- Completion
- 2027-01-03
Countries
- China
Study Locations
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