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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009288
Receipt No. R000010905
Scientific Title Change Hemodialysis patients' Activity and Impaired functions by chair Rising exercise
Date of disclosure of the study information 2012/11/17
Last modified on 2013/11/09

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Basic information
Public title Change Hemodialysis patients' Activity and Impaired functions by chair Rising exercise
Acronym CHAIR
Scientific Title Change Hemodialysis patients' Activity and Impaired functions by chair Rising exercise
Scientific Title:Acronym CHAIR
Region
Japan

Condition
Condition Hemodialysis patients
Classification by specialty
Nephrology Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of chair-rising exercise on ADL, QOL, muscular strength and size, physical activity, and cognitive function in hemodialysis patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in FIM (functional independence measure)
Key secondary outcomes 1) Change in QOL assessed by SF-36
2) Change in muscular strength of quadriceps
3) Change in walking distance in 6 minutes
4) Change in duration of chair rising exercise
5) Change in thigh circumference
6) Change in cognitive function assessed by 3MS
7) Change in blood tests (serum albumin, hemoglobin, and others)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Chair-rising exercise
Interventions/Control_2 Stretching exercise
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Hemodialysis patients
2) 60 years old or older
3) Amburatory
Key exclusion criteria 1) Symptomatic ischemic heart disease
2) Symptomatic peripheral artery disease
3) Arthritis
4) History of stroke with severe paralysis
5) COPD
6) Pregnancy
7) Those who are inappropriate for the study judged by the attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Shoji
Organization Osaka City University Graduate School of Medicine
Division name Department of Geriatrics and Vascular Medicine
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3930
Email t-shoji@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shota Matsufuji
Organization Inoue Hospital
Division name Department of Rehabilitation
Zip code
Address 16-17, Enoki-cho, Suita, Osaka 564-0053, Japan
TEL 06-6385-8651
Homepage URL
Email dorosousu_1@yahoo.co.jp

Sponsor
Institute Department of Geriatrics and Vascular Medicine, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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
2012 Year 11 Month 17 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
2012 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 08 Day
Last modified on
2013 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010905

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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