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Study of the effect of acupressure point massage in improving balance of elderly women

Protocol summary

Study aim
Determination of the effect of acupressure on elderly balance
Design
74 elderly women after acquiring informed consent, in available sampling method with randomized allocate intervention, will divided in two intervention and control groups (each comprising 37). Acupressure will be used to improve the static and dynamic balance in the intervention group.To determine the effect of acupressure on elderly balance, the static and dynamic balance test before intervention, two weeks and four weeks after intervention will measure.
Settings and conduct
This study will be conducted in the daycare centers in Qazvin. After referring to these centers, the researcher will select 74 subjects from the qualified elderly women and then they will be allocated randomly into the intervention and control groups. The intervention group will receive the massage of acupressure points three times per week for four weeks. Static and dynamic balance of the two groups will be measured before and after the intervention.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age over 60 years old, Interested in participating in the study Not having cognitive problems in the implementation of a simple command, The ability to communicate verbally exclusion criteria: Neuro muscular disorders ,Neurological disorders ,Neurological and environmental defects, Having diabetes with neurological complications, Balanced and stretching exercises over the past 6months, Get regular medications that interfere with balance control for example:antidepressants,benzodiazepines,anti psychotics, Severe eyesight, Severe hearing loss
Intervention groups
Intervention group includes elderly women which receive acupressure point message intervention. control group includes elderly women which receive routine daily care.
Main outcome variables
static and dynamic balance of elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181110041606N1
Registration date: 2018-12-27, 1397/10/06
Registration timing: retrospective

Last update: 2018-12-27, 1397/10/06
Update count: 0
Registration date
2018-12-27, 1397/10/06
Registrant information
Name
Zeinab Zajkani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3369 6563
Email address
z.zajkani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-10-07, 1397/07/15
Trial completion date
2018-10-07, 1397/07/15
Scientific title
Study of the effect of acupressure point massage in improving balance of elderly women
Public title
the effect of acupressure on elderly balance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years old Interested in participating in the study Not having cognitive problems in the implementation of a simple command The ability to communicate verbally
Exclusion criteria:
Neuro muscular disorders ,Neurological disorders ,Neurological and environmental defects Having diabetes with neurological complications Balanced and stretching exercises over the past 6months Get regular medications that interfere with balance control for example:antidepressants,benzodiazepines,anti psychotics Severe eyesight Severe hearing loss
Age
From 60 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Actual sample size reached: 74
More than 1 sample in each individual
Actual sample size in each individual: 0
Samples were divided into intervention and control groups
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment using a randomized block design. At first, the size of the 4 blocks was considered, according to the number of samples, 19 blocks were selected based on the table of random numbers and Individuals were assigned to intervention and control groups based on the status of the blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Gazvin University ofMedicai Sciences
Street address
Gazvin University of MedicalSciences,Bahonar Blvd.
City
Gazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.QUMS.REC.1396.301

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Dynamic and Static Balance
Timepoint
Before intervention and two weeks and four weeks after intervention
Method of measurement
1-TUG test 2-Step test 3-Tandem test 4-Stand on one leg test

Secondary outcomes

1

Description
Timepoint
Method of measurement

Intervention groups

1

Description
Intervention group: In the intervention groups, 3 times weekly for 4 weeks the specified pressure points will given message. Massage will done routinely with a thumb finger (Liv3,UB6,SP9,GB34,UB17, GB30, GB21, GB20) and elbow (UB11-UB25) mildly about persons tolerance will done. (Liv3,UB6,SP9,GB34,UB17,GB30,GB20) points about 1 minute and (UB11-UB25,GB21) points about 2 minutes will given Massage. message for all the points will be take twenty minutes.
Category
N/A

2

Description
Control group: Control groups will receive usual daily routine nursing care center without any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for eldely Daily Hoor
Full name of responsible person
Fatemeh Ranjkesh
Street address
Qazvin university of medical sciences, Bahonar Blvd., Qazvin city
City
Gazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
Franjkesh@qums.ac.ir

2

Recruitment center
Name of recruitment center
Center for eldely Daily Mehrepooya
Full name of responsible person
Fatemeh Ranjkesh
Street address
Qazvin university of medical sciences, Bahonar Blvd., Qazvin city
City
Gazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
Franjkesh@qums.ac.ir

3

Recruitment center
Name of recruitment center
Center for eldely Daily Aram
Full name of responsible person
Fatemeh Ranjkesh
Street address
Qazvin university of medical sciences, Bahonar Blvd., Qazvin city
City
Gazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
Franjkesh@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Vice Chancellor for Research and Technology Shahid Beheshti, Ave' Qazvin' IRAN
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All the data have code to identify.
When the data will become available and for how long
In 2019
To whom data/document is available
Qazvin University of Medical Sciences
Under which criteria data/document could be used
By confirmation of Qazvin University of Medical Sciences
From where data/document is obtainable
Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
Refer to Qazvin University of Medical Sciences or sending email to franjkesh@qums.ac.ir
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