Protocol summary

Summary
The aim of this study is to determine the effect of Tai Chi exercises on postural stability and control in old patients with knee osteoarthritis. Patients with knee osteoarthritis ( Kellgren-lawrence≥2); with age higher than 60 years old and with BMI less than 40 kg/m² included in study. 14 females and 6 males with knee osteoarthritis voluntarily participate in this study. These voluntaries are trained with Tai Chi twice a week for 8 weeks.Each session last 60 minutes. Areas and Mean velocities are measured by Force plate in standing position before and after Tai Chi.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206191722N8
Registration date: 2013-09-12, 1392/06/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-12, 1392/06/21
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences- Vice Chancellor for Education
Expected recruitment start date
2013-07-18, 1392/04/27
Expected recruitment end date
2013-12-17, 1392/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Tai Chi exercises on postural stability and control in old people with knee osteoarthritis
Public title
The Effect of Tai Chi on balance in old people with knee osteoarthritis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:age above 60 years old; with BMI less than 40 kg/m²;with knee osteoarthritis; Kellgren-lawrence≥2 ; VAS 3-4; Mini-Mental Examination>24; Berg>41; WOMAC<60; with ability to stand independently for higher than one minute on feet to achieve parameters of force plate. Exclusion criteria: with history of seizure, dizziness, diabetes, Parkinson disease and other diseases that can cause disturbance in balance; with history of Tai Chi or other exercises like yoga; with history of intra- joint steroid injection for the past 6 months; with past history of knee surgery or fracture of knee; treatment with physiotherapy in time of study ;with past history of heart disease; with anxiety questioner( Beck)>12.
Age
From 60 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Tehran University of Medical sciences
Street address
Floor 6-TUMS central Bulding-Gods St.Keshavarz Bouevard
City
Tehran
Postal code
Approval date
2013-07-17, 1392/04/26
Ethics committee reference number
130/714/د/92

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Primary gonarthrosis(arthrosis of knee): NOS

Primary outcomes

1

Description
Areas and Mean velocity
Timepoint
before and after intervention
Method of measurement
Force plate

Secondary outcomes

1

Description
postural stability and control
Timepoint
before and after intervention
Method of measurement
Force plate

Intervention groups

1

Description
60 minutes Tai Chi sessions (twice a week for 8 weeks).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas rehabilitation center
Full name of responsible person
Elham Ghandali
Street address
sattarkhan,Bargh alestom,nirogah bargh
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
postgraduate Studied and Research Program, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jalili
Street address
The Seventh Floor- Main Building Tehran University of Medical Sciences-Ghods Str-Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
postgraduate Studied and Research Program, Tehran University of Medical Sciences
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
Rehabilitation faculty, Tehran University of Medical Sciences
Full name of responsible person
Elham ghandali
Position
Msc student
Other areas of specialty/work
Street address
Rehabilitation faculty,pich e shemiran,enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
e-ghandali@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences,TUMS
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Professor, Faculty of Rehabilitation, TUMS
Other areas of specialty/work
Street address
Rehabilitation faculty, pich e shemiran, enghlab street
City
Tehran
Postal code
Phone
+98 21 7753 6134
Fax
+98 21 7753 4133
Email
hadianrs@sina.tums.ac.ir; hadian_ras@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation faculty, Tehran University of Medical Sciences
Full name of responsible person
Elham ghandali
Position
Msc student
Other areas of specialty/work
Street address
Rehabilitation faculty,pich e shemiran,enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
e-ghandali@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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