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


Email



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


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name