UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006260 |
|---|---|
| Receipt number | R000007312 |
| Scientific Title | The effect of exercise program for elderly persons requiring long-term care at a day service facility in Japan |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2011/08/31 15:08:36 |
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Basic information
Public title
The effect of exercise program for elderly persons requiring long-term care at a day service facility in Japan
Acronym
The effect of exercise program at a day service facility
Scientific Title
The effect of exercise program for elderly persons requiring long-term care at a day service facility in Japan
Scientific Title:Acronym
The effect of exercise program at a day service facility
Region
| Japan |
Condition
Condition
elderly persons certified by long-term care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the effect of "low-intensity resistance training with slow movement and tonic generation" on physical fitness of elderly persons certified by long-term care insurance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
30-second chair-stand test
Key secondary outcomes
knee extension force(kg),3m timed up and go test(sec.),single-leg standing(sec.),functional reach(cm),grip strength(kg),weight(kg),long-term care need condition
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
| Maneuver |
Interventions/Control_1
Low-intensity resistance training with Slow movement and Tonic force generation
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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
persons certified in long-term care insurance
persons who can walk
Key exclusion criteria
persons not certified in long-term care insurance
persons who can not walk
person who have hypertension and are not treated(over 180/110mmHg)
persons who have severe osteoporosis
persons who have heart diseases that are not controlled
persons who are recommended not to do exercise from their family doctors
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayamizu Satoshi |
Organization
Sanno Rehab. Clinic
Division name
a division of medical service
Zip code
Address
3-4-2 higashiyukigaya,Ohta-ward,Tokyo
TEL
03-5754-2672
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayamizu Satoshi |
Organization
Sanno Rehab. Clinic
Division name
a division of medical service
Zip code
Address
3-4-2 higashiyukigaya,Ohta-ward,Tokyo
TEL
03-5754-2672
Homepage URL
nss16@msn.com
Sponsor or person
Institute
Sanno Rehab. Clinic
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
Tokyo Bay Rehabilitation Hospital
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
山王リハビリ・クリニック(東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2011 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007312
