An interventional study of Physical Enrichment and Cognitive Enrichment in Stroke, Hypertension and Type 2 Diabetes Mellitus (T2DM), sponsored by Duke Kunshan University. Not yet recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Duke Kunshan University · Not applicable, Interventional, and Health services research
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 365 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Duke Kunshan University is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants continue routine community-based stroke and chronic disease management, including usual follow-up and medication adherence or health education provided by community healthcare professionals. They do not receive the structured CEEEC-II physical, nutrition, or AI-enabled cognitive enrichment program.
Participants receive a 12-week upgraded physical and nutrition enrichment program comprising eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. The program integrates age-appropriate aerobic, resistance, balance, and flexibility exercises, Baduanjin-based movements, practical nutrition education, and between-session practice support.
Behavioral: Physical Enrichment
Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. Health education is integrated with age-adapted games delivered through an AI-enabled interactive large screen to engage memory, attention, processing speed, visuospatial ability, and executive function, with between-session practice support.
Behavioral: Cognitive Enrichment
Participants receive both 12-week enrichment components: the upgraded physical and nutrition program and the AI-enabled large-screen cognitive program. Delivery comprises eight physician-led Vitality Camp sessions, four volunteer-led reinforcement activities, and between-session practice support.
Behavioral: Physical Enrichment · Behavioral: Cognitive 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.
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.
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.
Time frame: Baseline and 12 weeks after intervention initiation
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.
Time frame: Baseline and 12 weeks after intervention initiation
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.
Time frame: Baseline and 12 weeks after intervention initiation
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.
Time frame: Baseline and 12 weeks after intervention initiation
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.
Time frame: Baseline and 12 weeks after intervention initiation
Short Physical Performance Battery Total Score
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.
Time frame: Baseline and 12 weeks after intervention initiation
Mini Nutritional Assessment-Short Form Total Score
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.
Time frame: Baseline and 12 weeks after intervention initiation
Patient Health Questionnaire-9 Total Score
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.
Time frame: Baseline and 12 weeks after intervention initiation
Systolic Blood Pressure
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.
Time frame: Baseline and 12 weeks after intervention initiation
Health-Related Quality of Life Assessed by the EQ-5D-5L Index
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.
Time frame: Baseline and 12 weeks after intervention initiation
EQ Visual Analogue Scale
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.
Time frame: Baseline and 12 weeks after intervention initiation
Medication Adherence Assessed by the 4-Item Morisky-Green-Levine Scale
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.
Time frame: Baseline and 12 weeks after intervention initiation
Physical Activity in Metabolic Equivalent Minutes per Week
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.
Time frame: Baseline and 12 weeks after intervention initiation
Basic Activities of Daily Living
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.
Time frame: Baseline and 12 weeks after intervention initiation
Instrumental Activities of Daily Living
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.
Time frame: Baseline and 12 weeks after intervention initiation
Number of Falls
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.
Time frame: During the 12-week intervention period
Number of Hospitalizations
The number of all-cause hospital admissions occurring during the intervention period is recorded for each participant.
Time frame: During the 12-week intervention period
Recurrent Stroke
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.
Time frame: During the 12-week intervention period
Dietary Behavior Score
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.
Time frame: Baseline and 12 weeks after intervention initiation
Plan to share: Undecided — The plan for sharing de-identified individual participant data has not yet been finalized. Any future sharing will require approval by the principal investigator and the responsible institution, consistency with participant consent and applicable ethics approvals, and compliance with relevant data protection requirements.
Start is estimated for Aug 2026; primary completion for Jan 2027, 4 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 4 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Duke Kunshan University