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NCT07778771

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

Sponsor: Duke Kunshan University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

365

Start Date

2026-08-31

Completion Date

2027-01-03

Last Updated

2026-08-21

Healthy Volunteers

Conditions

Stroke Hypertension Type 2 Diabetes Mellitus (T2DM)Multimorbidity

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

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.

Locations (1)

Participating Community Health Service Centers in Kunshan

Kunshan, Jiangsu, China