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

NCT07778771 · tracked via the Priya Life Science China tracker

Sponsor

Duke Kunshan University

Phase

Not applicable

Started

2026-08-31

Last updated

2026-08-21

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

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

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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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07778771 on ClinicalTrials.gov ↗ ← All trials in China