Protocol summary

Summary
This is a randomized clinical study. The research community, are elderly persons who are members of “JAHAN DIDEGAN association” in 6th Area of Tehran during 1395-1396.For doing that, at first, researcher will refer to mentioned association to invite members for cooperation. Researcher will choose 60 persons who are qualified among volunteers. Qualification factors are age between 60-80years, not history and lack of acute or chronic debilitating diseases, Psychotic or mental illness, problems that lead to ban exercise such as history of Arthroplasty surgery in the lower limbs, fracture, severe deformity in organs, hard arthritis, mental problems, balance disorders and finally catching score in body balance tests. The first evaluation in this research will achievable by using tools before randomized allocation. At the end of first evaluation, participants according to quad random block will divide into 2 groups, control and intervention. Intervention participants under the supervision of coach and researcher will participate in Tai Chi Chuan exercise program during 8 weeks and 2 sessions per week in 45 min. at the end of 16 sessions again research tools will be completed by elderly members of both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016121931465N1
Registration date: 2017-01-23, 1395/11/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-23, 1395/11/04
Registrant information
Name
Lida Hosseini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61054412021
Email address
l-hosseini@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-12-30, 1395/10/10
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of" Tai chi chuan "exercise on balance and fear of falling among community dwelling older adults
Public title
Tai chi chuan effect on balance and fear of falling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Age 60 to 80 years; Not history of acute or chronic debilitating disease; Not history of psychotic or mental illness; Lack of problems that lead to ban exercise such as history of artroplastic surgery of the lower limbs, having a history of fracture, despite severe deformity in the lower limbs, which prevents the exercise or disease that physical activity is forbidden for them; Not having joint problems such as arthritis and severe arthritis; Lack of cognitive problems and earn higher scores of 24, based on mini mental status examination; There are balance disorders based on earn scores on diagnostic tests balance. Exclusion criteria: During the study, the risk of an acute illness which is prevents the exercise; Lack of interest in continuing to participate in research; Participate in sports activities that are considered similar exercise
Age
From 59 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
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
Faculty of Nursing and Midwifery
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran
City
Tehran
Postal code
1419733171
Approval date
2016-07-18, 1395/04/28
Ethics committee reference number
IR.TUMS.FNM.REC.1395.323

Health conditions studied

1

Description of health condition studied
Fall
ICD-10 code
R26.2
ICD-10 code description
Tendency to fall because of old age or other unclear health problems

Primary outcomes

1

Description
Balance
Timepoint
Before intervention and after intervention
Method of measurement
Tinetti Scale- Timed Get up and Go test

2

Description
Fear of Fall
Timepoint
Before intervention and after intervention
Method of measurement
Fall Efficacy Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: Tai chi chuan exercise, 8 weeks, twice a week, Each session is 45 minutes
Category
Prevention

2

Description
Control Group: No Action
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Police Retirement Center
Full name of responsible person
Elham Navab
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice Chancellor of Research
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Departmant of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Vice Chancellor of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Navab
Position
phD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 2610 1319
Fax
Email
e_navab100@hotmail.com; enavab@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Elham Navab
Position
phD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 2610 1319
Fax
Email
e_navab100@hotmail.com; enavab@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Navab
Position
phD of Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Eastern Nosrat, Tohid Square, Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 2610 1319
Fax
Email
e_navab100@hotmail.com; enavab@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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