UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045105
Receipt number R000051525
Scientific Title Effect of walking program on chronic leg edema, quality of life and behavioral and psychological symptoms of dementia among patients with dementia in chair-bound conditions.
Date of disclosure of the study information 2021/08/16
Last modified on 2021/10/17 20:13:51

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Basic information

Public title

Effect of walking program on chronic leg edema, quality of life and behavioral and psychological symptoms of dementia among patients with dementia in chair-bound conditions.

Acronym

Effect of walking program on chronic leg edema, quality of life and behavioral and psychological symptoms of dementia among patients with dementia in chair-bound conditions.

Scientific Title

Effect of walking program on chronic leg edema, quality of life and behavioral and psychological symptoms of dementia among patients with dementia in chair-bound conditions.

Scientific Title:Acronym

Effect of walking program on patients with dementia in chair-bound conditions.

Region

Japan


Condition

Condition

dementia

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Our objectives is to investigate the effect of walking program on changes in leg edema, QOL, BPSD among wheelchair-bound patients with dementia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Leg circumferences (before intervention/ after 2 week intervention)

Key secondary outcomes

The Neuropsychiatric Inventory-Brief Questionnaire Form(NPI-Q), DEMQOL-proxy (before intervention/ after 2 week intervention)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Wakling program 2 times a day
Term: 2 weeks

Interventions/Control_2

Regular activities (such as ordinary music therapy or occupational therapy) without walking program
Term: 2 weeks

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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients admitted to Koyogaoka hospital psychiatric ward who give their own or family's informed consent/ Patients who are diagnosed with dementia/ Patients who keep sitting position for more than 9 hours.

Key exclusion criteria

Patients who are diagnosed with severe heart disease, vascular disease, or kidney diseases/ Patients who are diagnosed with cellulitis, infection, pressure ulcer, or any type of traumatized skin/ Patients whose psychomotor activity is too severe for intervention/ Patients who are judged by a doctor or a nurse to be unsuitable for participation in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Ozaki

Organization

Koyogaoka Hospital

Division name

Medical office

Zip code

093-0084

Address

1-5-1, Koyogaoka, Abashiri, Hokkaido, Japan

TEL

08065052718

Email

ozakit1989@gmail.com


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Ozaki

Organization

Koyogaoka Hospital

Division name

Medical office

Zip code

093-0084

Address

1-5-1, Koyogaoka, Abashiri, Hokkaido, Japan

TEL

08065052718

Homepage URL


Email

ozakit1989@gmail.com


Sponsor or person

Institute

Koyogaoka Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Koyogaoka Hospital

Address

1-5-1, Koyogaoka, Abashiri, Hokkaido, Japan

Tel

08065052718

Email

ozakit1989@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

2021 Year 08 Month 16 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

Completed

Date of protocol fixation

2021 Year 03 Month 03 Day

Date of IRB

2021 Year 04 Month 20 Day

Anticipated trial start date

2021 Year 05 Month 10 Day

Last follow-up date

2021 Year 08 Month 31 Day

Date of closure to data entry

2021 Year 08 Month 31 Day

Date trial data considered complete

2021 Year 08 Month 31 Day

Date analysis concluded

2021 Year 10 Month 17 Day


Other

Other related information



Management information

Registered date

2021 Year 08 Month 10 Day

Last modified on

2021 Year 10 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051525


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name