NCT07778771Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 21.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 365 (tervezett)
- Első benyújtás
- 2026. aug. 18.
- Kezdés
- 2026. aug. 31.
- Elsődleges befejezés
- 2027. jan. 3.
- Fő szponzor
- Duke Kunshan University
- NCT-szám
- NCT07778771
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 365
- 2026. aug. 31. és az elsődleges befejezés (2027. jan. 3.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- A new stroke, transient ischemic attack, acute coronary event, or hospitalization for decompensated heart failure within the previous 3 months.
Más betegség
- 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.
Laborértékek
- Extreme glycemic instability, including fasting blood glucose >16.7 mmol/L or severe hypoglycemia requiring assistance within the previous month, until clinically reassessed.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 60 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Participating Community Health Service Centers in Kunshan | Kunshan | Kína | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.