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Comparing the effect of Taichi and close kinetic chain exercise on the knee osteoarthritis

Protocol summary

Summary
Objectives: Comparing the effect of Tai chi and close kinetic chain exercise on the knee osteoarthritis. Design: double-blind study. The patients will be treated in three groups: close kinetic chain exercises, Tai chi and control group. Patients will be assessed before treatment, after the sixth, twelfth and one month after treatment. Methods: subjects are men and women with grades 2 and 3of knee osteoarthritis, age 45-65 years, referring to the Municipality clinic in region 13 of Tehran. Sample size: 16 people in each group. Interventions: Applying ultrasound (1MHZ, 80 % pulse, intensity 1W/Cm2, 5 min), infrared ( 15 minutes) in three groups. Tai chi group: 5 minute warm up, 5 minute cool down exercises at the beginning and the end of sessions, 10 minutes of the 6th. Form of Yang style of tai chi exercise. Close kinetic chain exercise group: 5 minute static stretching as warm up at the beginning and 5 minutes static stretching as cool down at the end of sessions, 10 minutes exercise including standing terminal knee extension, mini squat in 15 degree of knee flex, step up from the front and side and lunge exercises. Main outcome measures: measuring of pain by visual Analog scale, flexion and extension knee range of motion by goniometry, joint swelling above and 5 cm upper and lower of the patella by tape, performance by the KOOS questionnaire and 6 -minute walk test, balance by Berg balance scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014010215936N1
Registration date: 2014-01-26, 1392/11/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-26, 1392/11/06
Registrant information
Name
Mehri Ghasemi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1723
Email address
mehri_ghasemi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences ( International Branch)
Expected recruitment start date
2013-12-16, 1392/09/25
Expected recruitment end date
2014-05-04, 1393/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Taichi and close kinetic chain exercise on the knee osteoarthritis
Public title
Comparing the effect of Taichi and close kinetic chain exercise on the knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : anterior knee pain(at least 3 in VAS) , grade 2 and 3 of knee OA, aged 45 to 65 years old; absence of : malignancy and infection in the knee, metabolic, endocrine, cardiovascular, neurological and other musculo- skeletal diseases that affect a person's standing, bursitis around the patella corticosteroid injection within recent thirty days, using of non-steroidal anti-inflammatory drugs during the prior week, fracture and open knee wound, knee surgery in the past six months, low back and hip surgery, knee pain duration less than one year, knee hyper mobility and instability, cruciate ligament injuries, severe swelling around the knee, psychological problems physical therapy in the prior six months, using of exercise therapy for improving the performance of the lower extremities in prior six months. Exclusion criteria: unwilling to continuing the treatment program; incomplete treatment; using of non-steroidal anti-inflammatory drugs or steroid injection in the knee joint during the study; if during the 6 minute walk test subjects have symptoms such as chest pain, dyspnea, leg cramp, staggering, excessive sweating, Enabling of completing the test, two consecutive absences in the treatment sessions.
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences,Next to Taleghani Hospital,Evin,Shahid Chamran free way,Tehran,1985717443,Iran
City
Tehran
Postal code
1985717443
Approval date
2013-10-07, 1392/07/15
Ethics committee reference number
116/2877

Health conditions studied

1

Description of health condition studied
Arthrosis of Knee
ICD-10 code
17.1
ICD-10 code description
Other primary gonarthrosis

Primary outcomes

1

Description
Pain
Timepoint
Before treatment, after the sixth, twelfth and one month after treatment
Method of measurement
visual Analogue scale

2

Description
Flexion and extension knee Range Of Motion
Timepoint
Before treatment, after the sixth, twelfth and one month after treatment
Method of measurement
Goniometry

3

Description
Joint swelling above and 5 cm upper and lower of the patella
Timepoint
Before treatment, after the sixth, twelfth and one month after treatment
Method of measurement
Tape

4

Description
Performance
Timepoint
Before treatment, after the sixth, twelfth and one month after treatment
Method of measurement
KOOS(Knee injury and Osteoarthritis Outcome Score) questionnaire and 6 -minute walk test

5

Description
Balance
Timepoint
before treatment, after the sixth, twelfth and one month after treatment
Method of measurement
Berg Balance Scale

Secondary outcomes

empty

Intervention groups

1

Description
Tai chi group: Applying ultrasound (1MHZ, 80 % pulse, intensity 1W/Cm2, 5 min), infrared ( 15 minutes),5 minute warm up exercises at the beginning of sessions, 10 minutes of the 6th. form of Yang style of tai chi exercise, 5 minute cool down exercises at the end of sessions.2.Close kinetic chain exercise group: Applying ultrasound (1MHZ, 80 % pulse, intensity 1W/Cm2, 5 min), infrared ( 15 minutes),5 minute static stretching of rectus femoris and hamstring muscles as warm up at the beginning of sessions, 10 minutes exercise including standing terminal knee extension( 10 second hold,10 times), mini squat in 15 degree of knee flex( 10 second hold,10 times), step up from the front (10 times),step up from the side(10 times) and lunge ( 10 second hold,10 times),Two minutes of rest between exercises, and 5 minutes static stretching of rectus femoris and hamstring muscles as cool down at the end of sessions.
Category
Rehabilitation

2

Description
Control group: applying ultrasound (1MHZ, 80 % pulse, intensity 1W/Cm2, 5 min), infrared ( 15 minutes).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Municipality clinic.number 13 , Tehran
Full name of responsible person
Mona Nahayatbin
Street address
Municipality clinic .number 13 , Shahid Hatami st,Damavand Ave,Tehran,1741683536,Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences ( International Branch)
Full name of responsible person
Kiandokht Ghanati
Street address
International Branch of Shahid Beheshti University of Medical Sciences,Tavanir street,across Hemat free way,Tehran,1424875451,Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences ( International Branch)
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
Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mehri Ghasemi
Position
PhD in physiotherapy
Other areas of specialty/work
Street address
Devision of Research, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences, OPP Bouali Hospital, Damavand Ave. Tehran, 1616913111, Iran.
City
Tehran
Postal code
1616913111
Phone
+98 21 7756 1723
Fax
+98 21 7759 1807
Email
mehri_ghasemi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Municipality clinic,number 13
Full name of responsible person
Mona Nahayatbin
Position
PT MSc student
Other areas of specialty/work
Street address
Municipality clinic,number 13,Shahid Hatami st,Damavand Ave,Tehran,1741683536, Iran.
City
Tehran
Postal code
1741683536
Phone
+98 21 7743 9933
Fax
Email
n_mona66@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Municipality clinic ,number 13
Full name of responsible person
Mona Nahayatbin
Position
PT MSc student
Other areas of specialty/work
Street address
Municipality clinic ,number 13,Shahid hatami st,Damavand Ave,Tehran,1741683536,Iran..
City
Tehran
Postal code
1741683536
Phone
+98 21 7795 7495
Fax
Email
n_mona66@yahoo.com
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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