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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04103463
Other study ID # YM108072F
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date July 31, 2021

Study information

Verified date September 2019
Source National Yang Ming University
Contact Yea-Ru Yang
Phone +886228267279
Email yryang@ym.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trail. A total of 28 individuals with aMCI will be randomly assigned to either the ISE group or control group. The ISE intervention conducts three times a week for 16 weeks. Outcomes are measured at baseline and after intervention. The primary outcomes are the Chinese version verbal learning test (CVVLT), selective reminding test (SRT), and logic memory test (Wechsler Memory Scale). The secondary outcomes are Montreal Cognitive Assessment (MoCA) for cognitive function, and trail making test Part A & B (TMT-A & B), Stroop test, and 25-item Executive Interview (C-EXIT 25) for executive function.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 100 Years
Eligibility Inclusion Criteria:

- Age=50 years

- Complained of memory impairment

- Chinese Version Verbal Learning Test 10-minute delays = 6 words

- MMSE score=24 and CDR score=0.5

- Activities of daily living are intact

- DSM-IV criteria for the diagnosis of dementia is not met

Exclusion Criteria:

- Any significant neurologic disease other than suspected incipient Alzheimer's disease

- Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interactive stepping exercise
An exercise intervention based on the principle of square stepping exercise
Home exercise
Home exercise

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Outcome

Type Measure Description Time frame Safety issue
Primary Chinese version verbal learning test Change from baseline at 12 week
Primary Selective reminding test Change from baseline at 12 week
Primary Wechsler Memory Scale-III Change from baseline at 12 week
Primary Logic memory test Change from baseline at 12 week
Secondary Montreal Cognitive Assessment Change from baseline at 12 week
Secondary Trail making test Change from baseline at 12 week
Secondary Stroop test Change from baseline at 12 week
Secondary Executive Interview Change from baseline at 12 week
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