Interactive Stepping Exercise on Memory

September 23, 2019 updated by: Yea-Ru Yang, National Yang Ming University

Effects of Interactive Stepping Exercise on Memory in Adults With Amnestic Mild Cognitive Impairment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive stepping exercise group
Other: Interactive stepping exercise
An exercise intervention based on the principle of square stepping exercise
Active Comparator: Home exercise group
Other: Home exercise
Home exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chinese version verbal learning test
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week
Selective reminding test
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week
Wechsler Memory Scale-III
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week
Logic memory test
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Montreal Cognitive Assessment
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week
Trail making test
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week
Stroop test
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week
Executive Interview
Time Frame: Change from baseline at 12 week
Change from baseline at 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YM108072F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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