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

Sponsor
Duke Kunshan University
Study ID
NCT07778771
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Physical Enrichment — BEHAVIORAL
    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.
  • Cognitive Enrichment — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Jan 3, 2027
Completion
Jan 3, 2027

Study Design

Enrollment
365 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Control Group
    Participants continue routine community-based stroke and chronic disease management, including usual follow-up and medication adherence or health education provided by community healthcare professionals. They do not receive the structured CEEEC-II physical, nutrition, or AI-enabled cognitive enrichment program.
  • Experimental: Behavioral: Multicomponent Physical and Nutrition Enrichment
    Participants receive a 12-week upgraded physical and nutrition enrichment program comprising eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. The program integrates age-appropriate aerobic, resistance, balance, and flexibility exercises, Baduanjin-based movements, practical nutrition education, and between-session practice support.
  • Experimental: Behavioral: AI-Enabled Large-Screen Cognitive Enrichment
    Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. Health education is integrated with age-adapted games delivered through an AI-enabled interactive large screen to engage memory, attention, processing speed, visuospatial ability, and executive function, with between-session practice support.
  • Experimental: Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality
    Participants receive both 12-week enrichment components: the upgraded physical and nutrition program and the AI-enabled large-screen cognitive program. Delivery comprises eight physician-led Vitality Camp sessions, four volunteer-led reinforcement activities, and between-session practice support.

Primary Outcome Measure

Intrinsic Capacity [ Time Frame: Baseline and 12 weeks after intervention initiation ]

Central Contacts

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