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.
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.
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.
Factorial
Physical Enrichment
BehavioralA 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
BehavioralA 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.
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.
Intrinsic Capacity Composite Score: Physical Enrichment Main Effect
The same intrinsic capacity composite score is used. The key secondary estimand is the adjusted marginal mean difference at Week 12 between physical-on and physical-off clusters, averaged over cognitive-factor levels and adjusted for baseline intrinsic capacity and community-level clustering. Higher scores indicate better intrinsic capacity.
Cognition Assessed by the Montreal Cognitive Assessment (MoCA)
Cognitive function is assessed using the Montreal Cognitive Assessment, which evaluates attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. A score of 26 or above is generally considered within the normal range.
MemTrax Correct-Recognition Accuracy
Correct-recognition accuracy is calculated from valid MemTrax trials according to the prespecified test validity algorithm and is expressed as a percentage from 0% to 100%. Higher values indicate better recognition performance.
MemTrax Correct-Response Time
Response time for correct MemTrax responses is summarized in milliseconds from valid trials according to the prespecified test validity algorithm. Lower response time indicates faster processing among valid correct responses.
Click on the lead sponsor to view all of their trials.
Duke Kunshan University
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Kunshan Hospital of Traditional Chinese Medicine
Collaborator
Shanghai Jiao Tong University School of Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
