Clinical trial NCT05483790: The Effects of Multidomain Non-pharmacological Interventions on the Elderly With or Without Mild Cognitive Impairment
Official title: Enhancing Latent Cognitive Capacity in Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment（MCI): a RCT Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
The Cognitive Normal Elderly
Keywords: mild cognitive impairment
the elderly
non-pharmacological intervention
cognitive function
magnetic resonance imaging
randomized controlled trial
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: School of Public Health，Fudan University
name: Medicine-Mental Health Center of Minhang District
name: Xinzhuang Community Health Service Center
First posted: 2022-08-02
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the intervention group and the control group
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: cognitive function assessed by the Mini-Mental State Examination (MMSE)
timeFrame: Before the intervention
measure: cognitive function assessed by the Mini-Mental State Examination (MMSE)
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
Secondary outcomes:
measure: memory function assessed by AVLT
timeFrame: Before the intervention
measure: memory function assessed by AVLT
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: memory function assessed by LMT
timeFrame: Before the intervention
measure: memory function assessed by LMT
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: executive function assessed by TMT-A
timeFrame: Before the intervention
measure: executive function assessed by TMT-A
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: executive function assessed by DSST
timeFrame: Before the intervention
measure: executive function assessed by DSST
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: concentration function assessed by DST
timeFrame: Before the intervention
measure: concentration function assessed by DST
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: quality of life assessed by the Barthel index
timeFrame: Before the intervention
measure: quality of life assessed by the Barthel index
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: quality of life assessed by EQ-5D-5L
timeFrame: Before the intervention
measure: quality of life assessed by EQ-5D-5L
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: quality of life assessed by IADL
timeFrame: Before the intervention
measure: quality of life assessed by IADL
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: quality of life assessed by PSMS
timeFrame: Before the intervention
measure: quality of life assessed by PSMS
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: quality of life assessed by SF-36
timeFrame: Before the intervention
measure: quality of life assessed by SF-36
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: social support assessed by SSRS
timeFrame: Before the intervention
measure: social support assessed by SSRS
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: quality of sleep assessed by PSQI
timeFrame: Before the intervention
measure: quality of sleep assessed by PSQI
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: emotion assessed by GDS-15
timeFrame: Before the intervention
measure: emotion assessed by GDS-15
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: cognitive function assessed by The Montreal Cognitive Assessment (MoCA)
timeFrame: Before the intervention
measure: cognitive function assessed by The Montreal Cognitive Assessment (MoCA)
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
Other outcomes:
measure: MRI--T1-weighted structure imaging
timeFrame: Before the intervention
measure: MRI--T1-weighted structure imaging
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: MRI--resting functional MRI (rfMRI) imaging
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
measure: MRI--resting functional MRI (rfMRI) imaging
timeFrame: Before the intervention
measure: MRI--diffusion-weighted imaging (DWI).
timeFrame: Before the intervention
measure: MRI--diffusion-weighted imaging (DWI).
timeFrame: 6 weeks, 12 weeks,3 months, 6 months, 12 months after the intervention
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Deputy Director, Professor, School of Public Health, Fudan University
name: Ying Wang, professor
role: STUDY_CHAIR
References: