NCT04103463

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

September 20, 2019

Last Update Submit

September 23, 2019

Conditions

Amnestic Mild Cognitive ImpairmentInteractive Stepping ExerciseMemoryCognitive FunctionExecutive Function

Keywords

square stepping exerciseAmnestic mild cognitive impairmentInteractive stepping exercisememorycognitive functionexecutive function

Outcome Measures

Primary Outcomes (4)

  • Chinese version verbal learning test

    Change from baseline at 12 week

  • Selective reminding test

    Change from baseline at 12 week

  • Wechsler Memory Scale-III

    Change from baseline at 12 week

  • Logic memory test

    Change from baseline at 12 week

Secondary Outcomes (4)

  • Montreal Cognitive Assessment

    Change from baseline at 12 week

  • Trail making test

    Change from baseline at 12 week

  • Stroop test

    Change from baseline at 12 week

  • Executive Interview

    Change from baseline at 12 week

Study Arms (2)

Interactive stepping exercise group

EXPERIMENTAL
Other: Interactive stepping exercise

Home exercise group

ACTIVE COMPARATOR
Other: Home exercise

Interventions

Interactive stepping exerciseOTHER

An exercise intervention based on the principle of square stepping exercise

Interactive stepping exercise group
Home exerciseOTHER

Home exercise

Home exercise group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yea-Ru Yang

CONTACT

+886228267279yryang@ym.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 25, 2019

Study Start

October 1, 2019

Primary Completion

December 31, 2020

Study Completion

July 31, 2021

Last Updated

September 25, 2019

Record last verified: 2019-09