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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05172661

Collaborator

(none)

Enrollment

Location

Arms

8.1

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment Parkinson Disease	Behavioral: Integrated physical-cognitive training Behavioral: Consecutive physical-cognitive training	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 26, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

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/session2 sessions/week6 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/session2 sessions/week6 weeks

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

Outcome Measures

Primary Outcome Measures

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 [8 weeks]
MoCA: 0-30 points, higher scores mean a better outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05172661

Other Study ID Numbers:

202109095RINA

First Posted:

Dec 29, 2021

Last Update Posted:

Jan 14, 2022

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Dual-task walking training

Parkinson's disease

Mild cognitive impairment

Electroencephalography

Additional relevant MeSH terms:

Parkinson Disease

Cognitive Dysfunction

Study Results

No Results Posted as of Jan 14, 2022