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 |
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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
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
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
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
