UMIN-CTR Clinical Trial

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
Institute	Koyogaoka Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051525