CEEEC-II: A 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity | NCT07778771 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 21, 2026

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

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07778771
Lead Sponsor: Duke Kunshan UniversityOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 365Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Aug 31, 2026Estimated
Primary Completion Date: Jan 3, 2027Estimated
Completion Date: Jan 3, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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
Brief 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.

Conditions

The medical conditions and diseases this study investigates.

Stroke
Hypertension
Type 2 Diabetes Mellitus (T2DM)

Interventions

The treatments and procedures being evaluated in this study.

Physical Enrichment
Cognitive Enrichment

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Health Services Research
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Yikang Yao, Graduate StudentContact

yikang.yao@duke.edu+86-18962917333

Locations

Where the study is run and whether each site is currently recruiting.

Participating Community Health Service Centers in Kunshan

Kunshan, Jiangsu 215300, China

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Duke Kunshan UniversityOTHER
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

CEEEC-II is the prospective, open-label extension of the CEEEC Phase I 2×2 factorial cluster-randomized trial (NCT06975501). The extension is conducted in 32 community health service stations in Kunshan, Jiangsu Province, China. Up to 420 participants who completed the Phase I endpoint assessment will be approached consecutively. The estimated Phase II enrollment is 356 participants, with a target of at least 320 participants completing the primary endpoint assessment. All participants will undergo a new eligibility review and provide written informed consent specifically for CEEEC-II.

No new randomization will occur. Each participating community health service station will retain its Phase I cluster assignment: physical and nutrition enrichment only, AI-enabled cognitive enrichment only, combined physical, nutrition, and cognitive enrichment, or usual community-based care. This preserves the original 2×2 factorial structure while recognizing that the Phase II cohort is a selectively re-consented extension cohort rather than a newly randomized sample.

Each participant will receive 12 weeks of the intervention assigned to the community cluster. The active program comprises eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. The upgraded physical and nutrition component integrates age-appropriate aerobic, resistance, balance, and flexibility exercises, incorporates Baduanjin-based movements, and provides practical nutrition education. The upgraded cognitive component combines health education with age-adapted, AI-enabled large-screen interactive games designed to engage memory, attention, processing speed, visuospatial ability, and executive function. Reinforcement activities and take-home materials support continued participation and practice between group sessions. Participants in the usual-care arm continue routine community-based stroke and chronic disease management without the structured Phase II physical or cognitive enrichment program.

Assessments will be conducted at baseline and approximately 12 weeks after intervention initiation. The primary outcome is an intrinsic capacity composite score derived from cognition, locomotion, vitality, and psychological capacity domains. The primary estimand is the marginal effect of the cognitive enrichment factor. The physical enrichment factor effect is a key secondary estimand. Cognitive function measured with the Montreal Cognitive Assessment is retained as a secondary outcome in continuity with Phase I. Other prespecified outcomes include MemTrax performance, physical function, nutritional status, depressive symptoms, blood pressure, health-related quality of life, medication adherence, physical activity, activities of daily living, falls, hospitalization, and recurrent stroke. Analyses will account for community-level clustering and the original factorial assignment.