UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038015
Receipt number R000043334
Scientific Title The examination of an effect of intensive large whole-body exercise on patients with Parkinson's disease
Date of disclosure of the study information 2019/09/15
Last modified on 2022/09/18 08:17:10

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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 or person

Institute

Kawamura Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043334


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name