CClinicalTrials.gg
Not yet recruitingNCT06371053Updated Apr 17, 2024

The Effect of Community Intervention on Different Degrees of Dementia

An interventional study of Community Intervention in Alzheimer Disease, sponsored by Babujinaya Cela. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.

Sponsored by Babujinaya Cela · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Alzheimer Disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 200 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Babujinaya Cela is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • 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

  • No intervention
    the blank group

    No intervention will be applied

Interventions

  • BehavioralCommunity 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 1 and day 14

Secondary outcomes

  1. 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.

    Time frame: day 1 and day 14

  2. 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.

    Time frame: day 1 and day 14

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06371053
Lead sponsor
Babujinaya Cela
Responsible party
Babujinaya Cela (Research Director, Buraidah Central Hospital) — Sponsor-investigator
First posted
Apr 17, 2024
Start date
Apr 2024 (estimated)
Primary completion
May 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Apr 17, 2024

Study contacts

Laviena Ce
Contact
linchuangzhuce@126.com
15422548954
Louis Wi
principal investigator · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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