Intensive Home-based Complex Training in Elderly

NCT06648343 | Completed

• 1 other identifier: 2020-09-005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm intervention study aimed at investigating whether a 4-week program of daily cognitive and physical activities, lasting 2-3 hours per day, produces significant changes in functional levels in healthy adults aged 65 and older.

Conditions

Elderly

Keywords

cognitive training; physical exercise; older adults

Outcome Measures

Primary Outcomes (1)

• K-MMSE (Korean Mini-Mental Status Examination)

  The Mini-Mental State Examination (MMSE) is a widely used screening tool for assessing cognitive function. It is designed to evaluate different cognitive abilities, including memory, attention, language, orientation, and visuospatial skills. The MMSE consists of a series of questions and tasks, with a maximum score of 30 points.

  4 weeks

Secondary Outcomes (3)

• RBANS (Repeatable Battery for the Assessment of Neuropsychological Status)

  4 weeks

• K-MBI (Korean Version of the Modified Barthel Index)

  4 weeks

• BBS (Berg Balance Scale)

  4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Intensive cognitive and physical training

Other: Intensive cognitive and physical training

Interventions

Intensive cognitive and physical training OTHER

The cognitive and physical training program consists of 25-35 minutes of cognitive training (memory, attention, visuospatial orientation) and 10-15 minutes of physical training (stretching, strength training, coordination, and aerobic exercise). Additionally, participants will be instructed to perform 30-40 minutes of aerobic exercise 3-4 times per week

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults aged 65 years or older.
• Individuals capable of independent daily living (including mobility).
• Individuals who fully understand the study and voluntarily agree to participate, providing written consent.

You may not qualify if:

• MMSE score less than 20 (19 or below will be excluded).
• Individuals with neurological conditions such as stroke, brain tumor, cerebral palsy, dementia, or Parkinson's disease.
• Individuals with serious medical conditions (cardiovascular, gastrointestinal, respiratory, endocrine, etc.) that compromise their general health.
• Participants currently involved in other clinical studies or who participated in another clinical trial within the past 30 days.
• Any other conditions deemed inappropriate for study participation by the researcher.

Sponsors & Collaborators

• Bundang CHA Hospital: lead
• Ministry of Science and ICT, Republic of Korea: collaborator
• The Korea Health Technology R&D Project through the Korea Health Industry Development Institute: collaborator

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13609, South Korea

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: September 25, 2020
• Primary Completion: November 6, 2020
• Study Completion: January 13, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

KR (1)