UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009288 |
|---|---|
| Receipt number | 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 17:19:19 |
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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
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
dorosousu_1@yahoo.co.jp
Sponsor or person
Institute
Department of Geriatrics and Vascular Medicine, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
