Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648343
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Intensive Home-based Complex Training in Elderly
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Cognitive and Physical Function Training in the Elderly
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Purpose of the Clinical Study The aim of this clinical study is to evaluate the effects of cognitive and physical function training in elderly individuals including those with subjective cognitive decline to aid in the development of preventive and therapeutic methods for dementia
Study Participants -Number of Participants and Basis This is a pilot study and no formal sample size calculation was performed The study will include 30 participants
Clinical Study Procedure and Assessment Visit 1 Screening During the screening visit the researcher will select participants based on the inclusionexclusion criteria All study-related assessments will take place after obtaining consent However if any assessments were performed within 7 days of the screening visit those results may be used instead The following activities will be conducted
Visit 2 Baseline Assessment Baseline assessments will be conducted and Visit 1 and Visit 2 can be performed on the same day The following activities will be conducted
After the baseline assessment participants will receive self-training materials for a 4-week program jointly developed by EBS Korea Educational Broadcasting System and Bundang CHA Hospital The cognitive and physical function training program will be conducted five times a week for 40 minutes per session The effectiveness will be evaluated through baseline assessments and post-training assessments will be conducted after 4 weeks to analyze the results
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
Participants will be provided with a self-training log to record whether they performed the exercise and to check adherence
Visit 3 Post-training Assessment After completing the 4-week cognitive and physical training program post-training assessments will be conducted
Study Participants -Number of Participants and Basis This is a pilot study and no formal sample size calculation was performed The study will include 30 participants
Clinical Study Procedure and Assessment Visit 1 Screening During the screening visit the researcher will select participants based on the inclusionexclusion criteria All study-related assessments will take place after obtaining consent However if any assessments were performed within 7 days of the screening visit those results may be used instead The following activities will be conducted
Visit 2 Baseline Assessment Baseline assessments will be conducted and Visit 1 and Visit 2 can be performed on the same day The following activities will be conducted
After the baseline assessment participants will receive self-training materials for a 4-week program jointly developed by EBS Korea Educational Broadcasting System and Bundang CHA Hospital The cognitive and physical function training program will be conducted five times a week for 40 minutes per session The effectiveness will be evaluated through baseline assessments and post-training assessments will be conducted after 4 weeks to analyze the results
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
Participants will be provided with a self-training log to record whether they performed the exercise and to check adherence
Visit 3 Post-training Assessment After completing the 4-week cognitive and physical training program post-training assessments will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None