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

NCT ID: NCT05483790

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2024-12-31

Brief Summary

The study aiming to investigate the efficacy, safety, and potential mechanism of a multimodal intervention on cognitive function in individuals with MCI or the cognitive normal elderly living in a community. The recruited elderly aged 50-75 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 multidimensional non-pharmacological intervention (cognitive training, physical exercise, healthy lifestyle intervention, and computerized interaction training) while the control group receives health education. Sociodemographics will be collected before the intervention. comprehensive neuropsychological tests and MRI will be collected before and 6 weeks, 12 weeks, 3 months, 6 months, 12 months after the randomization respectively.

Detailed Description

This study is a 6-week training phase and 6-week maintenance phase 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, 12 weeks,3 months, 6 months, 12 months after the randomization respectively.

The intervention group receive four intervention components including cognitive training, physical exercise, healthy lifestyle intervention, and computerized cognitive training. a multimodal intervention program (with schedule) was conducted in the intervention group for 6-week training phase and 6-week maintenance, including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. Throughout the 12-week period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks).

The in-person training course started with a 10-minute period of reminiscence and discussion. Subsequently, cognitive training activities were conducted for 25 minutes, followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, participants summarized the all-training activities, either through writing or discussion, and planed their homework during a 15-minute wrap-up session.

The cognitive training encompassed memory-related training (i.e. picture recall, categorization, cueing, repetition, association, sentence formation, story construction, utilization of the Roman room method, face-name association, and verbalization to aid retention) and attention-related training (i.e. character-picture association, idiom-picture association, and spot-the-difference tasks were incorporated). The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills, such as managing stressful life events and handling anger and frustration. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.

The instructor-supervised, computer program-based computerized interaction training three times weekly included spatial cognition (i.e. participants manipulated identical cubes or two-dimensional figures in different orientations using a control handle), left and right brain balance tasks (i.e. replicating graphics from one computer screen to another using action tracking or screen touching technology), clock imitation exercises (i.e. participants mimicked the movements of hour and minute hands to match the time displayed on the computer screen), and automatic teller machine simulation (i.e. wherein participants performed transactions like cash withdrawals, money transfers, and balance checks using a computer interface similar to an ATM, while also recalling passwords and transaction amounts.

The every-day homework encompassed activities such as calligraphy practice (2 days per week) and physical exercise (the other 5 days per week). Participants were asked to complete their homework within approximately 30 minutes and share pictures or videos of their homework in a WeChat group each day, allowing for assessment of their adherence.

The trial is conducted by local health workers, who were trained by a team comprising neurologists and geriatrics experts from Huashan Hospital. The training manuals, demo videos, education resources (such as PowerPoint files and materials) and standardized health education study materials were also distributed to them.

The control group receives regular health advice weekly through brochures, home visits, or telephone calls during 6-week training phase and 6-week maintenance period, 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.

Conditions

Mild Cognitive Impairment; The Cognitive Normal Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

multidomain intervention

The interventions were conducted for 6-week training phase and 6-week maintenance phase. Including cognitive training, physical exercise, healthy lifestyle education, and computerized interaction training. The multimodal intervention program included the in-person training course (90-minute, once per week for 6 weeks), computerized interaction training (30-minute, 3 times per week for 6 weeks), and homework (30-minute, every day for 12 weeks).

Group Type: EXPERIMENTAL

the multimodal intervention

Intervention Type: BEHAVIORAL

The in-person training course included 25 minutescognitive training activities were conducted for , followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, 15 minutes wrap-up session.

The cognitive training encompassed memory-related training and attention-related training. The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.

the control

Throughout the 6-week training phase and 6-week maintenance period, the control group only received 30-minute health education through booklets, home visits, or phone calls once every week.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

the multimodal intervention

The in-person training course included 25 minutescognitive training activities were conducted for , followed by a 15-minute healthy lifestyle education. After a 10-minute break, physical exercise training was administered for 15 minutes. Finally, 15 minutes wrap-up session.

The cognitive training encompassed memory-related training and attention-related training. The physical exercise included finger exercises, elastic band exercises, Tai Chi/ Baduanjin with guidance. The healthy lifestyle education included guidance on nutrition, sleep, stress management, and mood adjustment by teaching problem-solving skills. Additionally, the intervention provided information and support to facilitate lifestyle changes and included discussions and practical exercises, such as tools for assessing dietary behavior.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Aged ≥50 and ≤75 years, Male or Female

2. The resident elderly or those who have lived in the sampled community for more than 6 months

3. Be able to communicate with investigators and understand the questionnaire questions

4. More than 6 years of education

5. Mild cognitive impairment according to the Peterson criteria

6. Volunteer to participate in the study

Exclusion Criteria

1. Individuals with neurological diseases

2. Cognitive decline due to other disorders (cerebrovascular disease, central nervous system infections, etc.)

3. Mental Disorders included in The Diagnostic and Statistical Manual of Mental Disorders of The American Psychiatric Association

4. Blindness, aphasia, or severe hearing impairment

5. History of myocardial infarction within the previous year, Unstable cardiac, renal, lung, liver or other severe chronic diseases

6. Coincident participation in another intervention trial

7. Using pharmacologic therapeutics for cognitive impairment.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

School of Public Health，Fudan University

UNKNOWN

Sponsor Role: collaborator

Medicine-Mental Health Center of Minhang District

UNKNOWN

Sponsor Role: collaborator

Xinzhuang Community Health Service Center

UNKNOWN

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huang Yanyan

Professor (Department of General Medicine, Department of Geriatrics)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ying Wang, professor

Role: STUDY_CHAIR

Deputy Director, Professor, School of Public Health, Fudan University

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2017YFC1310504

Identifier Type: -

Identifier Source: org_study_id