Effects of Physical-Cognitive Training With Different Task Models in Parkinson's Disease With Mild Cognitive Impairment

February 1, 2023 updated by: National Taiwan University Hospital

Effects of Physical-Cognitive Training With Different Task Models on Dual-Task Walking in Parkinson's Disease With Mild Cognitive Impairment

The present study will characterize exercise model effects (integrated model vs. consecutive model) of physical-cognitive exercise on dual-task walking control in Parkinson's disease with mild cognitive impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

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 Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a diagnosis of idiopathic Parkinson's disease
  • have decreased cognitive functions but do not interfere with functional independence
  • Montreal Cognitive Assessment (MoCA): 21-25
  • able to walk independently without walking devices for at least 10 meters and with the ability to turn 180°

Exclusion Criteria:

  • a diagnosis of dementia
  • other diseases that may influence cognitive functions or walking performance
  • a history of brain surgery
  • modification of the medication during the exercise intervention

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: Integrated training model

Participants in this group will accept postural and cognitive training at the same time, e.g. naming animals while standing on the foam.

Each training session will last for 70 minutes, twice a week, and 12 sessions in total.
Behavioral: Integrated physical-cognitive training
Perform a postural task and a cognitive task at the same time (dual-task model) 70 minutes/session*2 sessions/week*6 weeks
Experimental: Consecutive training model

Participants in this group will accept postural and cognitive training separately and for identical durations (both 30 minutes).

Each training session will last for 70 minutes, twice a week, and 12 sessions in total.
Behavioral: Consecutive physical-cognitive training
Perform a postural task and a cognitive task separately for identical durations 70 minutes/session*2 sessions/week*6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline dual-task walking performance at 8 weeks
Time Frame: 8 weeks
8 weeks
Fall frequency
Time Frame: 20 weeks
20 weeks
Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks
Time Frame: 8 weeks
MoCA: 0-30 points, higher scores mean a better outcome
8 weeks

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

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 (Actual)

November 26, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 12, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202109095RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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