Academic Journal
Impact of different degrees of social engagement interventions (DDSEIs) on cognitive performance and brain activity in community-dwelling adults with subjective cognitive decline in Nanjing, China: a randomised controlled trial protocol.
| Τίτλος: | Impact of different degrees of social engagement interventions (DDSEIs) on cognitive performance and brain activity in community-dwelling adults with subjective cognitive decline in Nanjing, China: a randomised controlled trial protocol. |
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| Συγγραφείς: | Li J; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Yang X; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Xu H; Nanjing Medical University Affiliated Geriatric Hospital, Nanjing, Jiangsu, China., Pan W; Suzhou Ruiying Rehabilitation Hospital, Suzhou, Jiangsu, China., Shi C; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Xia N; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Cheng Y; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Meng F; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Li H; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Liu J; Clinical Medicine Research Institution, Jiangsu Province People's Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, China., Qi M; Department of Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China., Wang T; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China., Reinhardt JD; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China ZhuYi1981@njmu.edu.cn reinhardt@scu.edu.cn.; Institute for Disaster Management and Reconstruction, Sichuan University, Chengdu, China.; Faculty of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland., Zhu Y; Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China ZhuYi1981@njmu.edu.cn reinhardt@scu.edu.cn. |
| Πηγή: | BMJ open [BMJ Open] 2026 Jul 21; Vol. 16 (7), pp. e108844. Date of Electronic Publication: 2026 Jul 21. |
| Τύπος έκδοσης: | Journal Article; Clinical Trial Protocol |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| Ιατρικοί όροι (MeSH): | Cognitive Dysfunction*/therapy , Cognitive Dysfunction*/psychology , Social Isolation*/psychology , Cognition* , Social Interaction* , Brain*, White Matter/diagnostic imaging ; Humans ; Aged ; China ; Female ; Male ; Middle Aged ; Aged, 80 and over ; Randomized Controlled Trials as Topic ; Independent Living ; Cognitive Training ; Cognitive Enhancement |
| Περίληψη: | Introduction: Social isolation may have adverse effects on incidence and severity of cognitive impairment including subjective cognitive decline (SCD). An increase of environmental variety and social interactions may furthermore reduce progression from SCD to dementia. Research evaluating respective interventions is limited, particularly as regards studies comparing different degrees of social engagement interventions. We thus developed a clinical trial protocol to determine the efficacy of social interventions with different intensities in protecting cognitive function and white matter integrity in socially isolated adults aged 45-85 with SCD. Methods and Analysis: This is a single-centre, three-arm randomised controlled trial with a 1:1:1 randomisation ratio, conducted from 1 December 2023 to 30 December 2026. The trial evaluates three study arms over a 12-week period: two social intervention arms (a social group intervention and a one-to-one social interaction intervention), both of which adopt a comprehensive model centred on social interaction and integrated with structured aerobic exercise and cognitive training; and a usual care arm in which participants receive only weekly health education. The sample size is estimated at 132 participants with SCD aged 45-85 years residing in Nanjing communities, China. Participants will be assigned to one of the three study groups via block randomisation stratified by gender. The principal outcome is improvement in mnemonic performance with delayed recall in the HuaShan version of the auditory verbal learning test between baseline and week 12. Secondary outcomes include improvement in white matter integrity measured by fractional anisotropy, along with changes in executive function, behavioural indicators and serum biomarkers assessed at baseline and week 12. Furthermore, follow-up evaluations with cognitive scales and serological data will take place at 3 months post-intervention. Ethics and Dissemination: Ethical approval for this trial has been obtained from the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (approval No. 2023-SR-726.A1). Written informed consent will be secured from all participants before they are enrolled in the study. Findings from the trial will be submitted for publication in peer-reviewed academic journals. Trial Registration Number: ChiCTR2400080312. (© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group.) |
| Competing Interests: | Competing interests: None declared. |
| Contributed Indexing: | Keywords: Clinical Protocols; Cognitive dysfunction; Community Participation; GERIATRIC MEDICINE |
| Entry Date(s): | Date Created: 20260721 Date Completed: 20260721 Latest Revision: 20260729 |
| Update Code: | 20260729 |
| PubMed Central ID: | PMC13404503 |
| DOI: | 10.1136/bmjopen-2025-108844 |
| PMID: | 42481202 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2025-108844 |