UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026127
Receipt number R000030021
Scientific Title Study of the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease
Date of disclosure of the study information 2017/02/14
Last modified on 2023/01/10 15:54:49

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study of the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease

Acronym

Cognitive function intervention of Parkinson's disease

Scientific Title

Study of the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease

Scientific Title:Acronym

Cognitive function intervention of Parkinson's disease

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine the effect of aerobic exercise and the cognitive training on cognitive function of Parkinson's disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Cognitive function

Key secondary outcomes

white matter integrity, depression, apathy, sleep disorders, arousal disorder, pain, fatigue, motor symptom, posture, and QOL.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Aerobic exercise
60 min per day, 2 days per week
added to conventional rehabilitation

Interventions/Control_2


Interventions/Control_3

Conventional rehabilitation only

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

60 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1) not dementia
2) H&Y stage 2-3

Key exclusion criteria

Patients who are complicated with other disease to influence a motor function, a cognitive function

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kohei
Middle name
Last name Marumoto

Organization

Hyogo Prefectural Rehabilitation Hospital at Nishi - Harima

Division name

Department of Physical Medicine and Rehabilitation

Zip code

679-5165

Address

1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo

TEL

0791-58-1050

Email

k.maru5081@gmail.com


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Marumoto

Organization

Hyogo Prefectural Rehabilitation Hospital at Nishi - Harima

Division name

Department of Physical Medicine and Rehabilitation

Zip code

679-5165

Address

1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo

TEL

0791-58-1050

Homepage URL


Email

k.maru5081@gmail.com


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science (JSPS)Grant-in-Aid for Young Scientists (B)

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hyogo Prefectural Rehabilitation Hospital at Nishi - Harima

Address

1-7-1, Kouto, Shingu-cho, Tatsuno, Hyogo

Tel

0791-58-1050

Email

k.maru5081@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

兵庫県立リハビリテーション西播磨病院


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 14 Day


Related information

URL releasing protocol

https://kaken.nii.ac.jp/file/KAKENHI-PROJECT-24591787/24591787seika.pdf

Publication of results

Unpublished


Result

URL related to results and publications

https://kaken.nii.ac.jp/file/KAKENHI-PROJECT-24591787/24591787seika.pdf

Number of participants that the trial has enrolled

40

Results

Our results showed that working memory as well as FA values of Genu and Body of corpus callosum and fornix could be relatively preserved in AEG.

Results date posted

2023 Year 01 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

This study examined effect of aerobic exercises on cognitive function and the White Matter Integrity (WMI) of patients with Parkinson's disease (PD).

Participant flow

Patients with PD were assigned to either a comfortable walking group (CWG): comfortable walking in addition to conventional rehabilitation or an aerobic exercise group (AEG): aerobic exercise training in addition to conventional rehabilitation.

Adverse events

No

Outcome measures

At the beginning of the treatment phase and 1 year later, patients were evaluated for motor function, peak oxygen uptake volume as an index of cardiorespiratory capacity, cognitive function such as working memory, and WMI using MRI.The White Matter Integrity was measured by Fractional Anisotropy (FA) values calculated with the diffusion tensor method.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2014 Year 07 Month 24 Day

Anticipated trial start date

2015 Year 03 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 14 Day

Last modified on

2023 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030021


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name