UMIN-CTR Clinical Trial

Basic information
Public title	The examination of an effect of intensive large whole-body exercise on patients with Parkinson's disease
Acronym	Intensive large whole-body exercise on patients with Parkinson's disease
Scientific Title	The examination of an effect of intensive large whole-body exercise on patients with Parkinson's disease
Scientific Title:Acronym	Intensive large whole-body exercise on patients with Parkinson's disease
Region	Japan

Condition
Condition	Parkinson's disease patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect and long-term effect of an intensive large whole-body exercise on motor and non-motor function in patients with Parkinson's disease
Basic objectives2	Others
Basic objectives -Others	To examine the effects by an intensive large whole-body exercise
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Unified Parkinson's disease rating scale
Key secondary outcomes	Parkinson's Disease Questionnaire-39 Geriatric depression scale Berg balance scale 10-m walking test timed up-and-go test 30-s chair stand test stabilometry Fall Efficacy Scale

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Lee Silverman Voice Treatment BIG. The program consisted of 1-hour individual therapy 4 times a week for 4 weeks (total 16 sessions) and an additional home training program.
Interventions/Control_2
Interventions/Control_3
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Symptoms stabilized by medication 2. Ambitious for rehabilitation and self-training 3. Agree to our rehabilitation schedule
Key exclusion criteria	History of other neurological disorders, severe orthopedic disease and cardiovascular disease
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Hirakawa
Organization	Kawamura Hospital
Division name	Department of Rehabilitation
Zip code	501-3144
Address	1-84Daihannya, Akutami, Gifu-city, Gifu
TEL	058-241-3311
Email	y.hirakawa2301@gmail.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Hirakawa
Organization	Kawamura Hospital
Division name	Department of Rehabilitation
Zip code	501-3144
Address	1-84Daihannya, Akutami, Gifu-city, Gifu
TEL	058-241-3311
Homepage URL
Email	y.hirakawa2301@gmail.com

Sponsor
Institute	Kawamura Hospital
Institute
Department

Funding Source
Organization	Kawamura Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawamura Hospital
Address	1-84Daihannya, Akutami, Gifu-city, Gifu
Tel	058-241-3311
Email	y.hirakawa2301@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

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 10 Month 26 Day
Date of IRB	2018 Year 11 Month 10 Day
Anticipated trial start date	2019 Year 09 Month 15 Day
Last follow-up date	2023 Year 03 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	2019 Year 09 Month 15 Day
Last modified on	2022 Year 09 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043334