The Effects of Multidomain Non-pharmacological Interventions on the Elderly With or Without Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title: Enhancing Latent Cognitive Capacity in Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment（MCI): a RCT Study

Status Active, not recruiting

Clinical Trial Summary

The aim of the study is to assess a multidomain non-pharmacological intervention for improvement or maintenance of cognitive functioning and reduction of cognitive decline in the non-demented elderly from the general population. To investigate brain structural and functional imaging changes following a multidomain intervention. The recruited elderly aged 55-75 years with normal cognitive function or MCI will be divided into the intervention group or the control group randomly. The intervention group will be accepted a 6-week multidimensional non-pharmacological intervention (cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training) while the control group receives a 6-week health education. Sociodemographics will be collected before the intervention. comprehensive neuropsychological tests and MRI will be collected before and 6 weeks after the intervention respectively.

Clinical Trial Description

This study is a 6-week randomized controlled trial, conducted at Xinzhuang Town, Minhang District, Shanghai, China.

All participants (control and intervention group) complete the data collection. Demographic data will be collected before intervention including age, sex, education, marriage, etc. A comprehensive cognitive assessment and MRI will be done before and 6 weeks after the intervention respectively. Data will be collected by self-report, home visit, or telephone visit.

The intervention group receive four intervention components including cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training. The intervention includes group and individual sessions. Participants will be divided into 3 groups to accept the sessions successively, and each group has a monitor regarded as the communication bridge between participants and teachers as well as remind participants to attend the training and do homework in time. The training sessions (once times per week, 90 min per session, 6 weeks) referred to the schedule. The group sessions with educational content on cognitive training, healthy lifestyle intervention, and physical exercise, the detail include memory methods and strategies, attention training, brain function development which belong to cognitive training, nutrition recommendation, sleep guidance, and emotional regulation which belong to lifestyle intervention, and the session also include parts of physical exercise such as gymnastics by finger or elastic band. The intervention will be trained by general practitioners and community health workers who accepted trained before the intervention. Individual sessions consist of human-computer interaction and physical exercise. Human-computer interaction is a kind of computer program-based cognitive training guided by professional staff at the study site, conducted in 6 weeks, 3 times per week, 20-30 minutes per session, and 12 sessions. The training program is a web-based in-house developed computer program including several tasks: spatial cognition (participants regulate and merge a couple of cubes or two-dimensional figures that are exactly alike but in different directions by control handle), left and right brain balance (copy the graphics on one computer screen to another computer screen by action tracking or screen touching technology), clock (participants imitate the hour and minute hands of a clock by swinging arms and show a time as same as in the computer screen) and ATM simulation (participants withdraw cash, transfer money, check balances through operating computer similar with ATM, among which need them to remember the password and the amount of money). Individual aerobic training included activities preferred by each participant (5 times per week,30 minutes per time), such as Tai Ji, Baduanjin, elastic band gymnastics or yoga, etc. The training will be guided and supervised by trained staff.

The control group receives regular health advice weekly through brochures, home visits, or telephone calls during 6 weeks of the intervention, detail including (1) patients with cognitive impairment education: prevention from self-injury, falling injury, accidental injury, medication, lost and bad habits; (2) inmates or caregivers education; (3) cognitive impairment knowledge education; (4) prevention of cognitive dysfunction education. The intervention committee ensures that health education activities are consistent across sites and unlikely to increase physical activity. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT05483790
• Study type: Interventional
• Source: Huashan Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2020
• Completion date: December 31, 2024