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CEEEC-II: A 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity
Condition(s) studied
StrokeHypertensionType 2 Diabetes Mellitus (T2DM)Multimorbidity
Investigational drug(s) / intervention(s)
Physical EnrichmentCognitive Enrichment
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.
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.
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Intrinsic Capacity — Baseline and 12 weeks after intervention initiation
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Participating Community Health Service Centers in Kunshan |
Kunshan |
Jiangsu |
|
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