The Combined Multicomponent Intervention Specifically in Rural Community Older Adults at High Risk for Mild Cognition Impairment (CMintervention)
13. mai 2026 oppdatert av: Xiaoying Wang
Elderly Disability (Dementia) Prevention and Intervention Project in Jinjiang Community, China
This project aims to test whether a combined multicomponent (CM) program - including health education, cognitive training, and traditional Chinese exercises - is feasible and effective for rural older adults who are at high risk of mild cognitive impairment (MCI).
The program is designed to help maintain or improve cognitive function and overall well-being.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Health education sessions: One 30-minute lecture every 4 weeks, covering topics such as diet, sleep, chronic disease management, and brain health.
Cognitive training: Weekly 45-minute sessions using fun mini-games to train memory, attention, arithmetic, and logical thinking.
Physical exercise: Weekly 45-minute sessions of traditional Chinese exercises (Baduanjin and Shiqiaoshou) to improve balance, flexibility, and fitness.
Studietype
Intervensjonell
Registrering (Faktiske)
235
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Fujian
-
Quanzhou, Fujian, Kina
- Yuxi, Gucuo, Su'an, Qianhong village
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥ 60;
- Suffering from chronic diseases, such as hypertension, diabetes mellitus, hyperlipidemia, cardiovascular and cerebrovascular diseases, or osteoarthritis;
- Mild cognitive impairment (defined as Mini-Mental State Examination (MMSE) score of 21-26 combined with either an AD8 self-rated cognitive impairment score ≥ 2 or a digit span (backward) test (DST) score < 4);
- Mild physical impairment (defined as an Activities of Daily Living (ADL) score < 26 and a Short Physical Performance Battery (SPPB) score of 7-10).
Exclusion Criteria:
- Age <60;
- Unable to move physically;
- Already suffering from Alzheimer's disease.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: CM intervention group
The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise.
The health education sessions were delivered once every four weeks, with each session lasting 30 minutes.
In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.
|
The CM intervention was a 24-week comprehensive program integrating health education, cognitive training, and physical exercise.
The health education sessions were delivered once every four weeks, with each session lasting 30 minutes.
In contrast, cognitive training and physical exercise sessions were conducted weekly, each with a duration of 45 minutes.
|
|
Ingen inngripen: Control group
the group that does not receive the intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cognitive Function
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Cognitive function was assessed using the Minimum Mental State Examination (MMSE) scale (Folstein, Folstein, & McHugh, 1975).The MMSE evaluates five domains: orientation, registration, attention and calculation, recall, and language abilities.
Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
|
From enrollment to the end of intervention at 48 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Body Mass Index
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Height (cm) was measured using a wall-mounted height board, with the participant standing upright without shoes.
Weight (kg) was measured using a electronic load cell scale, with light indoor clothing and after voiding.
Body Mass Index (BMI) was calculated by dividing a person's weight in kilograms by the square of their height in meters (kg/m²).
|
From enrollment to the end of intervention at 48 weeks
|
|
Waist circumference
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Waist circumference (cm) was measured using a flexible, non-elastic tape measure at the midpoint between the lowest rib and the iliac crest, with the participant standing and breathing normally.
The measurement is taken to the nearest 0.1 cm at the end of normal expiration.
|
From enrollment to the end of intervention at 48 weeks
|
|
Blood pressure
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Blood pressure was assessed by measuring systolic and diastolic pressures (mmHg).
|
From enrollment to the end of intervention at 48 weeks
|
|
Activities of daily living
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Activities of daily living were assessed via the Activities of daily living (ADL) scale (Ferrucci et al., 1996).
It employs a scoring range of 14 to 56, with higher scores indicating poorer functional ability.
|
From enrollment to the end of intervention at 48 weeks
|
|
Physical performance
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Physical performance was assessed via the Short Physical Performance Battery (SPPB) scale (Cruz-Jentoft et al., 2010).
It has a scoring range of 0 to 12, with higher scores reflecting better physical performance.
|
From enrollment to the end of intervention at 48 weeks
|
|
Participant adherence
Tidsramme: From enrollment to the end of intervention at 48 weeks
|
Participant adherence was summarized as the proportion of total participants who attended at least 50% of the intervention sessions, and separately for those who attended at least 75% of the sessions.
|
From enrollment to the end of intervention at 48 weeks
|
|
Participant satisfaction
Tidsramme: From intervention at 36 weeks to the end of intervention at 48 weeks
|
Participant satisfaction was assessed using a self-developed scale, with a total score of 30 points; higher scores indicated greater satisfaction with the program.
|
From intervention at 36 weeks to the end of intervention at 48 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. august 2024
Primær fullføring (Faktiske)
11. oktober 2025
Studiet fullført (Faktiske)
11. oktober 2025
Datoer for studieregistrering
Først innsendt
26. april 2026
Først innsendt som oppfylte QC-kriteriene
13. mai 2026
Først lagt ut (Faktiske)
15. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- No. XDYX202411K77
- 2022YFC3603000 (Annet stipend/finansieringsnummer: the National Key Research and Development Program of China)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .