StrokeCEEEC-IINCT07778771
CEEEC-II: A 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity
A study testing Physical Enrichment and Cognitive Enrichment in people with Stroke and Hypertension, run by Duke Kunshan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Stroke, Hypertension, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Physical Enrichment and Cognitive Enrichment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2026to 3 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Participating Community Health Service Centers in Kunshan
Kunshan, Jiangsu, 215300
Lijing Yan, Professor, +86-512-3665-7057, lijing.yan@duke.edu
About this study
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
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 the 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.
- Conditions
- Stroke, Hypertension, Type 2 Diabetes Mellitus (T2DM), Multimorbidity
- Being tested
- Physical Enrichment, Cognitive Enrichment
- Keywords
- Intrinsic Capacity, Older Adults, Community Health Services, Environmental Enrichment, Cognitive Training, Physical Exercise, Multicomponent Intervention, Cluster-Assigned Extension Study
- Medical subject headings
- Stroke, Hypertension, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical EnrichmentBehavioural
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.
Cognitive EnrichmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Behavioral: Multicomponent Physical and Nutrition Enrichment | Experimental | 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. Receives: Behavioral: Physical Enrichment |
| Behavioral: AI-Enabled Large-Screen Cognitive Enrichment | Experimental | 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. Receives: Behavioral: Cognitive Enrichment |
| Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality | Experimental | 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. Receives: Behavioral: Physical Enrichment; Behavioral: Cognitive Enrichment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks after intervention initiation
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start31 Aug 2026 (estimated)
- Primary completion3 Jan 2027 (estimated)
- Study completion3 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke Kunshan University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Kunshan Hospital of Traditional Chinese Medicine, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Lijing Yan, Duke Kunshan University
- Investigators
- Lijing Yan, Professor, Principal investigator, Duke Kunshan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778771
- Sponsor's protocol ID
- CEEEC-II-2026
- Other IDs
- 06975501
- Acronym
- CEEEC-II
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07778771
- Acronym / sponsor ID
- CEEEC-II / CEEEC-II-2026
- Conditions
- Stroke, Hypertension, Type 2 Diabetes Mellitus (T2DM), Multimorbidity
- Keywords
- Intrinsic Capacity, Older Adults, Community Health Services, Environmental Enrichment, Cognitive Training, Physical Exercise, Multicomponent Intervention, Cluster-Assigned Extension Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Duke Kunshan UniversityUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Kunshan Hospital of Traditional Chinese Medicine, Shanghai Jiao Tong University School of Medicine
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 3 Jan 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Behavioral: Multicomponent Physical and Nutrition Enrichment | Experimental | Behavioral: Physical EnrichmentParticipants 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: AI-Enabled Large-Screen Cognitive Enrichment | Experimental | Behavioral: Cognitive EnrichmentParticipants 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. |
| Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality | Experimental | Behavioral: Physical Enrichment, Behavioral: Cognitive EnrichmentParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical EnrichmentA 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. | Behavioural | Behavioral: Multicomponent Physical and Nutrition Enrichment, Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality |
| Cognitive EnrichmentA 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. | Behavioural | Behavioral: AI-Enabled Large-Screen Cognitive Enrichment, Participants receive a 12-week cognitive enrichment program comprising eight physician-led Vitality |
Primary outcome
Intrinsic Capacity
Time frame: 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.
18 secondary outcomes
Intrinsic Capacity Composite Score: Physical Enrichment Main Effect
Time frame: Baseline and 12 weeks after intervention initiation
Cognition Assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and 12 weeks after intervention initiation
MemTrax Correct-Recognition Accuracy
Time frame: Baseline and 12 weeks after intervention initiation
MemTrax Correct-Response Time
Time frame: Baseline and 12 weeks after intervention initiation
Short Physical Performance Battery Total Score
Time frame: Baseline and 12 weeks after intervention initiation
Mini Nutritional Assessment-Short Form Total Score
Time frame: Baseline and 12 weeks after intervention initiation
Patient Health Questionnaire-9 Total Score
Time frame: Baseline and 12 weeks after intervention initiation
Systolic Blood Pressure
Time frame: Baseline and 12 weeks after intervention initiation
Health-Related Quality of Life Assessed by the EQ-5D-5L Index
Time frame: Baseline and 12 weeks after intervention initiation
EQ Visual Analogue Scale
Time frame: Baseline and 12 weeks after intervention initiation
Medication Adherence Assessed by the 4-Item Morisky-Green-Levine Scale
Time frame: Baseline and 12 weeks after intervention initiation
Physical Activity in Metabolic Equivalent Minutes per Week
Time frame: Baseline and 12 weeks after intervention initiation
Basic Activities of Daily Living
Time frame: Baseline and 12 weeks after intervention initiation
Instrumental Activities of Daily Living
Time frame: Baseline and 12 weeks after intervention initiation
Number of Falls
Time frame: During the 12-week intervention period
Number of Hospitalizations
Time frame: During the 12-week intervention period
Recurrent Stroke
Time frame: During the 12-week intervention period
Dietary Behavior Score
Time frame: Baseline and 12 weeks after intervention initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Preceding CEEEC Phase I trialLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lijing Yan, Professor principal investigator
Duke Kunshan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Enrichment and Cognitive Enrichment in people with Stroke and Hypertension, run by Duke Kunshan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yikang Yao, Graduate Student (+86-18962917333, yikang.yao@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrinsic Capacity (time frame: Baseline and 12 weeks after intervention initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.