Hypertension, Multimorbidity, Stroke, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
Intrinsic Capacity, Older Adults, Community Health Services, Environmental Enrichment, Cognitive Training, Physical Exercise, Multicomponent Intervention, Cluster-Assigned Extension Study
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.
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.
Interventions
BEHAVIORALPhysical 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.
BEHAVIORALCognitive 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.
Sponsors
Duke Kunshan University
Beijing Tiantan Hospital
Kunshan Hospital of Traditional Chinese Medicine
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Participants, care providers, and investigators are aware of the cluster-assigned intervention. Blinding of outcome assessors cannot be guaranteed.
Intervention model description
CEEEC-II retains the 2×2 factorial cluster assignments generated by randomization in the preceding CEEEC Phase I trial (NCT06975501). Eligible participants who re-consent for CEEEC-II remain in the intervention condition assigned to their community cluster in Phase I. No new randomization or reassignment occurs in CEEEC-II.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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 outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrinsic Capacity Composite Score: Physical Enrichment Main Effect | Baseline and 12 weeks after intervention initiation | 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) | Baseline and 12 weeks after intervention initiation | 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 | Baseline and 12 weeks after intervention initiation | 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 | Baseline and 12 weeks after intervention initiation | 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. |
| Short Physical Performance Battery Total Score | Baseline and 12 weeks after intervention initiation | The Short Physical Performance Battery assesses standing balance, usual-pace gait speed over 4 meters, and five repeated chair stands. Each component is scored from 0 to 4, producing a total score from 0 to 12. Higher scores indicate better lower-extremity physical function. |
| Mini Nutritional Assessment-Short Form Total Score | Baseline and 12 weeks after intervention initiation | Nutritional status is assessed using the Mini Nutritional Assessment-Short Form. The total score ranges from 0 to 14, with higher scores indicating better nutritional status. Scores of 12-14 indicate normal nutritional status, 8-11 indicate risk of malnutrition, and 0-7 indicate malnutrition. |
| Patient Health Questionnaire-9 Total Score | Baseline and 12 weeks after intervention initiation | Depressive symptoms are assessed using the 9-item Patient Health Questionnaire. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms and poorer psychological capacity. |
| Systolic Blood Pressure | Baseline and 12 weeks after intervention initiation | Seated systolic blood pressure is measured in millimeters of mercury using a standardized protocol after an appropriate rest period. The prespecified analysis uses the mean of valid readings. |
| Health-Related Quality of Life Assessed by the EQ-5D-5L Index | Baseline and 12 weeks after intervention initiation | Health-related quality of life is assessed using the EuroQol 5-Dimension 5-Level descriptive system covering mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Health states are converted to an index value using the prespecified value set; higher index values indicate better health-related quality of life. |
| EQ Visual Analogue Scale | Baseline and 12 weeks after intervention initiation | Participants rate their current health on the EuroQol visual analogue scale from 0 to 100, where 0 represents the worst health they can imagine and 100 represents the best health they can imagine. |
| Medication Adherence Assessed by the 4-Item Morisky-Green-Levine Scale | Baseline and 12 weeks after intervention initiation | Medication adherence is assessed using the 4-item Morisky-Green-Levine self-report scale. The total score ranges from 0 to 4, with higher scores indicating poorer medication adherence. A score of 0 indicates high adherence, 1-2 medium adherence, and 3-4 low adherence. |
| Physical Activity in Metabolic Equivalent Minutes per Week | Baseline and 12 weeks after intervention initiation | Physical activity is summarized as metabolic equivalent of task minutes per week from the prespecified physical activity questionnaire. Higher values indicate a greater volume of physical activity. |
| Basic Activities of Daily Living | Baseline and 12 weeks after intervention initiation | Basic activities of daily living include ambulation, feeding, dressing, personal hygiene, continence, and toileting. The study score ranges from 0 to 12, with higher scores indicating greater limitation and poorer functional independence. |
| Instrumental Activities of Daily Living | Baseline and 12 weeks after intervention initiation | Independent living skills are assessed using the Lawton Instrumental Activities of Daily Living scale. The study score ranges from 0 to 14, with higher scores indicating greater limitation and poorer independent function. |
| Number of Falls | During the 12-week intervention period | The number of participant-reported falls occurring during the intervention period is recorded. Falls resulting in injury or medical attention are additionally classified for safety reporting. |
| Number of Hospitalizations | During the 12-week intervention period | The number of all-cause hospital admissions occurring during the intervention period is recorded for each participant. |
| Recurrent Stroke | During the 12-week intervention period | The occurrence of a new ischemic or hemorrhagic stroke during the intervention period is recorded based on participant or family report and available clinical documentation. |
| Dietary Behavior Score | Baseline and 12 weeks after intervention initiation | Dietary behaviors relevant to stroke and cardiometabolic risk management are assessed using the prespecified study questionnaire. The scoring direction and calculation follow the finalized questionnaire and data dictionary. |
Countries
China
Contacts
CONTACTYikang Yao, Graduate Student
CONTACTLijing Yan, Professor
PRINCIPAL_INVESTIGATORLijing Yan, Professor
Duke Kunshan University
Outcome results
None listed