Physical and Cognitive Activity Programs for Older Stroke Survivors With Other Chronic Conditions

Trial details

Who runs it

Duke Kunshan University

Trial code

NCT07778771

Record updated

21 August 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: A new stroke, transient ischemic attack, acute coronary event, or hospitalization for decompensated heart failure within the previous 3 months; Life-threatening disease or another condition associated with an expected survival of less than 6 months; An absolute contraindication to unsupervised community exercise or another medical condition judged by the study clinician to make participation unsafe; A severe musculoskeletal, neurological, visual, hearing, cognitive, psychiatric, or communication impairment that prevents safe participation or valid completion of study procedures; Extreme glycemic instability, including fasting blood glucose >16.7 mmol/L or severe hypoglycemia requiring assistance within the previous month, until clinically reassessed; Uncontrolled resting blood pressure (systolic >=180 mmHg or diastolic >=110 mmHg after repeated measurement) until clinically reassessed and controlled; Unable to walk to the community site even with a cane or walker, or dependent on a wheelchair for attendance; 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.

ClinicalTrials.gov NCT07778771