CEEEC-II: A 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity
CEEEC-II
A 12-Week, Multicenter, Open-Label, 2×2 Factorial, Cluster-Assigned Extension Study of Upgraded Physical and AI-Enabled Large-Screen Cognitive Enrichment for Older Stroke Survivors With Multimorbidity in Kunshan, China
2 other identifiers
interventional
365
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Aug 2026
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2026
CompletedFirst Posted
Study publicly available on registry
August 21, 2026
CompletedStudy Start
First participant enrolled
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 3, 2027
August 21, 2026
August 1, 2026
4 months
August 18, 2026
August 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intrinsic Capacity
The intrinsic capacity composite is the equally weighted mean of four domain z scores standardized using the CEEEC-II baseline distribution: cognition \[the mean of standardized MemTrax correct-recognition accuracy and reverse-coded log-transformed correct-response time\], locomotion \[Short Physical Performance Battery total score\], vitality \[Mini Nutritional Assessment-Short Form total score\], and psychological capacity \[reverse-coded Patient Health Questionnaire-9 total score\]. Higher scores indicate better intrinsic capacity. The primary estimand is the adjusted marginal mean difference at Week 12 between cognitive-on and cognitive-off clusters, averaged over physical-factor levels and adjusted for baseline intrinsic capacity and community-level clustering.
Baseline and 12 weeks after intervention initiation
Secondary Outcomes (18)
Intrinsic Capacity Composite Score: Physical Enrichment Main Effect
Baseline and 12 weeks after intervention initiation
Cognition Assessed by the Montreal Cognitive Assessment (MoCA)
Baseline and 12 weeks after intervention initiation
MemTrax Correct-Recognition Accuracy
Baseline and 12 weeks after intervention initiation
MemTrax Correct-Response Time
Baseline and 12 weeks after intervention initiation
Short Physical Performance Battery Total Score
Baseline and 12 weeks after intervention initiation
- +13 more secondary outcomes
Study Arms (4)
Control Group
NO INTERVENTIONParticipants 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.
Behavioral: Multicomponent Physical and Nutrition Enrichment
EXPERIMENTALParticipants 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.
Behavioral: AI-Enabled Large-Screen Cognitive Enrichment
EXPERIMENTALParticipants 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.
Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Completed the endpoint assessment of the preceding CEEEC Phase I trial (NCT06975501) and remains under management at a participating community health service station in Kunshan.
- Age 60 years or older.
- Hospital-confirmed ischemic or hemorrhagic stroke in a stable stage, with no new or worsening neurological deficit within the previous 3 months.
- Registered hypertension and/or type 2 diabetes mellitus; other comorbid conditions are permitted.
- Willing and able to participate in the 12-week community-based extension program and complete baseline and endpoint assessments.
- Able to travel to the community site independently or with a cane or walker; not dependent on a wheelchair for attendance.
- Short Physical Performance Battery total score \>=3, or able to maintain a supported side-by-side standing position for 10 seconds when the total score is \<3.
- Able to communicate in Mandarin Chinese or the Kunshan dialect and able to recognize Arabic numerals.
- Corrected vision sufficient to identify large characters at approximately 40 cm and at least one upper limb able to complete touchscreen selection.
- Resides in the participating community and has no plan to move away during the study period.
- Provides written informed consent specifically for CEEEC-II.
You may not qualify if:
- Life-threatening disease or another condition associated with an expected survival of less than 6 months.
- A new stroke, transient ischemic attack, acute coronary event, or hospitalization for decompensated heart failure within the previous 3 months.
- Uncontrolled resting blood pressure (systolic \>=180 mmHg or diastolic \>=110 mmHg after repeated measurement) until clinically reassessed and controlled.
- Extreme glycemic instability, including fasting blood glucose \>16.7 mmol/L or severe hypoglycemia requiring assistance within the previous month, until clinically reassessed.
- An absolute contraindication to unsupervised community exercise or another medical condition judged by the study clinician to make participation unsafe.
- Unable to walk to the community site even with a cane or walker, or dependent on a wheelchair for attendance.
- A severe musculoskeletal, neurological, visual, hearing, cognitive, psychiatric, or communication impairment that prevents safe participation or valid completion of study procedures.
- Unable to recognize Arabic numerals or unable to complete touchscreen selection with either upper limb.
- Current participation in another structured physical, cognitive, or nutrition intervention study that may contaminate the assigned intervention.
- Any other reason documented by the study clinician as making the individual unsuitable for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Kunshan Universitylead
- Shanghai Jiao Tong University School of Medicinecollaborator
- Beijing Tiantan Hospitalcollaborator
- Kunshan Hospital of Traditional Chinese Medicinecollaborator
Study Sites (1)
Participating Community Health Service Centers in Kunshan
Kunshan, Jiangsu, 215300, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lijing Yan, Professor
Duke Kunshan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants, care providers, and investigators are aware of the cluster-assigned intervention. Blinding of outcome assessors cannot be guaranteed.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 18, 2026
First Posted
August 21, 2026
Study Start
August 31, 2026
Primary Completion (Estimated)
January 3, 2027
Study Completion (Estimated)
January 3, 2027
Last Updated
August 21, 2026
Record last verified: 2026-08