Protocol summary

Study aim
Main: Determining Taichi's effect on physical performance and the rate of fall of elderly women.Subsection: Determining and comparing the balance, walking speed, strength of the limb, physical performance, and the rate of fall of elderly women before and after the intervention in the test and control group
Design
Community Based and Practical Clinical Trial, with Parallel,Randomized Groups
Settings and conduct
Lahijan city, 24 weekly sessions per test group
Participants/Inclusion and exclusion criteria
Entrance: Female aged 60 to 74, willingness to attend, speak Persian, read and write Absence of psychological disorder based on the short-term AMT criteria, lack of experience in Tai Chi Sports exercises in the past 12 months, the ability to perform daily life activities, a history of at least one fall during the last year, and a score of 7 and above of a screening tool that crashed, did not have Disobedience to exercise, lack of vision and hearing. Outcome: Unwillingness to continue to participate in research Admission to the hospital during the study, reduced ability to complete the exercise program with the statement of the elderly, lack of regular attendance in Tai Chi exercises (4 consecutive sessions)
Intervention groups
The effect of Tai Chi exercise on the test group; the control group was not tested
Main outcome variables
Non-pharmacological interventions from nurses to the elderly to stimulate more elderly people to improve their quality of life. In the macro planning in the region, there is a solution for improving the health of the elderly care centers. Primary messages: Strengthening the muscles of the organs and improving balance control; Secondary outcomes: Preventing and reducing the fall, increasing the quality of life, reducing dependence on daily living activities, increasing Safety, reducing the risk of bone fractures, reducing hospitalization and treatment costs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180426039425N1
Registration date: 2018-08-11, 1397/05/20
Registration timing: registered_while_recruiting

Last update: 2018-08-11, 1397/05/20
Update count: 0
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
smat nourbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4242 7149
Email address
s.nourbakhsh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tai chi exercise on physical activity and the rate of fall of elderly women
Public title
Effect of Taichi's exercise on physical performance and fall rates
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly women aged 60 to 74 years Desire to participate in research Spoken in farsi Have reading and writing skills Lack of psychosocial disorder. Accordingly, the ten-point ten-line AMT will be used for the arrival of the elderly who are studying at grade 7 and above. Not having a history of Tai Chi Sports exercises in 12 months Ability to do daily life activities (using the daily life activities tool and score 12 points higher Having a history of at least one fall during a recent year and a score of 7, the highest of the fall screening tool Not having a medical bar to exercise Not having vision and hearing problems (to the extent that there is no problem in the relationship) Not having vision and hearing problems (to the extent that there is no problem)
Exclusion criteria:
Unwillingness to continue to participate in research Hospital admission during study Decreasing the ability to complete an exercise program with the elderly saying Regular absenteeism in Tai Chi practice (4 consecutive sessions)
Age
From 60 years old to 74 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the samples were first selected by sampling method, taking into account input criteria. Then, after group matching with the underlying variables, the samples are randomly divided into two groups of test and control. So that the names of 60 people are numbered, then by random assignment, the number of couples (30 people) in the control group and the individual numbers (30) will be in the test group.
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
پژوهشکده سلامت دانشگاه علوم پزشکی و خدمات درمانی بابل
Street address
Babol University of Medical Sciences, Babol University of Medical Sciences, Babol, Iran
City
babol
Province
Mazandaran
Postal code
47745-47176
Approval date
2018-03-02, 1396/12/11
Ethics committee reference number
MUBABOL.HRI.REC.1396.231

Health conditions studied

1

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

Primary outcomes

1

Description
Physical performance
Timepoint
Before intervention and after intervention
Method of measurement
Short Physical Performance Battery

2

Description
Fall rate
Timepoint
Before intervention and at the end of week 4, end of week 8 and end of week 12 intervention
Method of measurement
Self-report checklist for falling occurrences

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: doing Tai Chi Yuan exercise twelve weeks, twice a week, 24 sessions, 60 minutes per session, women aged 60 to 74, elderly with a history of falling over the past year according to entry criteria.
Category
Prevention

2

Description
Control group: No action
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
مراکز بهداشت شهری لاهیجان
Full name of responsible person
عصمت نوربخش
Street address
ایران، گیلان، لاهیجان، مراکز بهداشت شهری لاهیجان
City
لاهیجان
Province
Guilan
Postal code
4414973936
Phone
+98 13 4222 9905
Email
smatnourbakhsh42@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
دکتر رضا قدیمی
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue,Babol
City
babol
Province
Mazandaran
Postal code
47745-47176
Phone
+98 11 3219 7667
Fax
+98 11 3219 7667
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Smat Nourbakhsh
Position
Senior Nursing Student Seniority
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farshid Building,Workers Alley 10,Golestan Street 31/1
City
Lahijan
Province
Guilan
Postal code
4414973936
Phone
+98 13 4242 7149
Fax
Email
s.nourbakhsh@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Smat Nourbakhsh
Position
Senior Nursing Student Seniority
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farshid Building,Workers Alley 10,Golestan Street 31/1
City
Lahijan
Province
Guilan
Postal code
4414973936
Phone
+98 13 4242 7149
Fax
Email
s.nourbakhsh@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Smat Nourbakhsh
Position
Senior Nursing Student Seniority
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Farshid Building,Workers Alley 10,Golestan Street 31/1
City
Lahijan
Province
Guilan
Postal code
4414973936
Phone
+98 13 4242 7149
Fax
Email
s.nourbakhsh@mubabol.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...