NCT05172661

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

November 29, 2021

Last Update Submit

February 1, 2023

Conditions

Mild Cognitive ImpairmentParkinson Disease

Keywords

Dual-task walking trainingParkinson's diseaseMild cognitive impairmentElectroencephalography

Outcome Measures

Primary Outcomes (3)

  • Change from baseline dual-task walking performance at 8 weeks

    8 weeks

  • Fall frequency

    20 weeks

  • Change from baseline Montreal Cognitive Assessment (MoCA) score at 8 weeks

    MoCA: 0-30 points, higher scores mean a better outcome

    8 weeks

Study Arms (2)

Integrated training model

EXPERIMENTAL

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

Consecutive training model

EXPERIMENTAL

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

Interventions

Integrated physical-cognitive trainingBEHAVIORAL

Perform a postural task and a cognitive task at the same time (dual-task model) 70 minutes/session\*2 sessions/week\*6 weeks

Integrated training model
Consecutive physical-cognitive trainingBEHAVIORAL

Perform a postural task and a cognitive task separately for identical durations 70 minutes/session\*2 sessions/week\*6 weeks

Consecutive training model

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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°

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Cognitive DysfunctionParkinson Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

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
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 29, 2021

Study Start

November 26, 2021

Primary Completion

June 30, 2022

Study Completion

September 30, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)