The Effect of Community Intervention on Different Degrees of Dementia

The Effect of Community Intervention on Different Degrees of Dementia: A Randomized Controlled Study

The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Community Intervention

Detailed Description

Regular exercise can increase brain function, improve memory, speed up cognitive processes, and fight off diseases like Alzheimer ' s and dementia.

The goal of this clinical trial is to explore the impact of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals (≥60 year old) with Alzheimer's disease. It primarily aims to address: the effects of Community Intervention on Dementia and Activities of Daily Living in community-dwelling elderly individuals with Alzheimer's disease in different degrees. All participants are required to undergo a continuous 2-week (14 days) Community Intervention, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laviena Ce; Phone Number: 15422548954; Email: linchuangzhuce@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 60 years old.
• No hospitalization within the past six months.
• Alzheimer's disease
• The elderly people who voluntarily participate and agree to adhere until the end of the study.

Exclusion Criteria:

• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Physical disability.
• Difficulty in mobility.
• Simultaneously receiving other therapies that might influence this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Community Intervention, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 15-20 minutes.	Behavioral: Community Intervention; The intervention includes Cognitive Training: Activities targeting memory, attention, language, and executive functions to maintain cognitive abilities. This could involve cognitive games, memory exercises, and daily tasks. Life Skills Training: Assistance in maintaining or relearning daily life skills such as personal hygiene, dressing, eating, and household chores. This could be through structured training programs and daily guidance. Physical Exercise: Providing appropriate physical activities and exercises to maintain physical health and function, including walking, balance training, and light strength training. Social Support: Organizing social activities and support groups to facilitate interaction and reduce social isolation and loneliness. Emotional Support: Offering mental health support and psychosocial services to help individuals cope with emotional challenges such as anxiety and depression.
No Intervention: the blank group; No intervention will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination	The Mini-Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, particularly in the elderly population. It evaluates various cognitive domains such as orientation, memory, attention, calculation, and language. The test consists of a series of questions and tasks, including asking the individual to state the current date, recall a list of words, perform simple calculations, and follow verbal commands. Each correct response earns a certain number of points, and the total score ranges from 0 to 30, with higher scores indicating better cognitive function.	day 1 and day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index	The Barthel Index is a scale used to measure a person's ability to perform activities of daily living. It was developed by Dr. Mahlon R. Barthel in the 1960s and has since been widely used in healthcare settings, particularly in rehabilitation and geriatric care. The scores range between 0 and 100, with higher scores indicating better activities of daily living.	day 1 and day 14
Functional near-infrared spectroscopy	Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique that measures changes in cerebral blood oxygenation and hemodynamics. It provides a way to monitor brain activity by measuring the concentration changes of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the cortical tissue. The numerical values displayed by near-infrared will be recorded, with higher values indicating more active brain blood flow.	day 1 and day 14

Collaborators and Investigators

• Sponsor: Babujinaya Cela
• Investigators: Principal Investigator: Louis Wi, Site Coordinator of United Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 13, 2024
• First Submitted That Met QC Criteria: April 13, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 13, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: community - dementia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No