UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004186 |
|---|---|
| Receipt number | R000005020 |
| Scientific Title | RCT of Tactile touch for elderly people |
| Date of disclosure of the study information | 2010/09/10 |
| Last modified on | 2011/12/01 14:22:01 |
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Basic information
Public title
RCT of Tactile touch for elderly people
Acronym
RCT of Tactile touch for elderly people
Scientific Title
RCT of Tactile touch for elderly people
Scientific Title:Acronym
RCT of Tactile touch for elderly people
Region
| Japan |
Condition
Condition
healthy elderly people
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to find the efficacy of tactile touch for healthy eldery people.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
HR, HRV(HF, LH/HF), Blood Pressure, Skin Temperature, Blood flow, finger pulse wave, VAS(relax-tension) and POMS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
rest(base line)(5min), Blood Pressure Measurement(2min), tactile touch for left hand (10min), rest(5min)
Interventions/Control_2
rest(base line)(5min), Blood Pressure Measurement(2min), rest(15min)
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The erderly people who has an ablily of decision making by oneself about the participation to the research, and who sends a normal social life and has a physical strength for going out alone.
Key exclusion criteria
plan to move/renovate, the damage of a blood vessel and the lymph of arms.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukari Kawahara |
Organization
The Japanese Red Cross College of Nursing
Division name
Department of Fundamental nursing
Zip code
Address
4-1-3, Hiroo, Shibuya, Tokyo, Japan, 150-0012
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Japanese Red Cross College of Nursing
Division name
Department of Fundamental Nursing
Zip code
Address
4-1-3, Hiroo, Shibuya, Tokyo, Japan, 150-0012
TEL
Homepage URL
Sponsor or person
Institute
The Japanese Red Cross College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
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
日本赤十字看護大学
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 10 | Day |
Last modified on
| 2011 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005020
