Comparison the effects of Tai Chi exercise and glucosamine supplementation on selected physical factors effective on balance and Falls Efficacy in elderly women with knee osteoarthritis
comparison the effect of Tai Chi exercise and glucosamine sulfate supplementation on some of the physical fitness factors associated balance and decreased the rate of falling in elderly women with knee osteoarthritis.
Design
This study is a clinical trial including one control and two intervention groups (Tai Chi and supplement), which eligible individuals randomly allocated to them. Allocation implemented by assigning different color cards to the subjects in parallel groups and in a non-blind research.
Settings and conduct
Purpose of this study is prevention of falling in the elderly women suffering from grade 2 and 3 knee osteoarthritis (according to kellegeren and Lawrence scale) in Qazvin. After medical confirmation, subjects divided into 3 groups (Tai chi, supplement and control groups). Before and after interventions, researchers examined balance, strength of lower limbs, Speed of movement, and fear of falling, in a non-blind research method
Participants/Inclusion and exclusion criteria
Entry requirements:
Being over 60 years;
Having knee osteoarthritis grade 2 and 3 according to the criteria of kellegeren and Lawrence;
Independence in daily activities;
Not having paralyzed part of the body;
Ability to answer questionnaire;
Exit Conditions:
having regular exercise;
having acute cardio-respiratory disease;
Earning a score less than 24 in Mini-Mental State test;
under treated for arthritis;
perform knee joint replacement .
Intervention groups
In this research, there are three groups of subjects;
Intervention group1: do Tai Chi exercise three times a week for three month; Intervention group 2: consumed glucosamine sulfate during this period With prescribing doctorand
control group that did not receive any intervention during 3 month.
Main outcome variables
balance; lower limb strength; movement speed; flexibility and fear of falling.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180314039092N1
Registration date:2018-06-11, 1397/03/21
Registration timing:retrospective
Last update:2018-06-11, 1397/03/21
Update count:0
Registration date
2018-06-11, 1397/03/21
Registrant information
Name
Elham Attari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3324 8863
Email address
elhamattari58@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-20, 1396/02/30
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
2017-11-21, 1396/08/30
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
Comparison the effects of Tai Chi exercise and glucosamine supplementation on selected physical factors effective on balance and Falls Efficacy in elderly women with knee osteoarthritis
Public title
The effect of Tai Chi exercise and Glucosamine supplementation on prevention of fall in the elderly women whit knee osteoarthritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
over 60 years of age
Having knee osteoarthritis grade 2 and 3 according to the criteria of kellegeren and Lawrence
Independence in performing daily activities
Not having paralysis in the body part
Ability to answer questionnaire questions
Exclusion criteria:
Having sports activities
having acute cardio-respiratory disease
Earn a score lower than 24 of the Mini Mental State test
They were under treatment for osteoarthritis
Perform knee joint replacement
Taking drugs that effective on balance
Age
From 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Following to public announcement (banners and flyers) for aging and arthritis conference, the conference was held in Qazvin city, and subjects was drawn from participants meeting our research criteria through a random assignment method (random number table). For each group, the color cards ( green, yellow, and blue card for the Tai Chi, supplement and control groups, respectively) was considered. After examining and confirming the subjects by medical professionals, eligible ones were referred to the project and a color card allocated to each one in a way that only researcher award of allocation process.considering the color of cards, researcher classified subjects into related groups and informed them of conditions and the interferes they would be received.
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 Committee Sabzevar Islamic Azad university
Street address
Dr Siadati Boulevard: Islamic Azad University of Sabzevar Complex
City
sabzevar
Province
Razavi Khorasan
Postal code
۹۶۱۸۹۵۶۸۷۸
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.IAU.S.REC.1396.16
Health conditions studied
1
Description of health condition studied
Elderly women With Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Speed of movement
Timepoint
10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured.
Method of measurement
The speed of movement was measured by using the time taken for a walk distance of 10 meters per person.
2
Description
static Balance
Timepoint
10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured.
Method of measurement
Static balance was measured by amount of swing when person standing 30 seconds with open and closed eyes on Iranian scientist balance calculator system
3
Description
Dynamic Balance
Timepoint
10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured.
Method of measurement
The dynamic balance was measured using the Time Up Go test. ،Time it takesfor a person until to lift up from the chair to go 3 meters distance and returns to the seat, it is measured
4
Description
lower limb strength
Timepoint
10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured.
Method of measurement
The strength of the lower limb was measured based on the number of times sitting and rising from the seat for 30 seconds
5
Description
Flexibility
Timepoint
10 days before and 10 days after the three-month training sessions of Tai Chi and supplementation of glucosamine were measured.
Method of measurement
Flexibility was measured using the Sit and Rich test
Secondary outcomes
1
Description
body swing
Timepoint
10 days before and 10 days after the three-month period of interventions
Method of measurement
TUG test
2
Description
Fall Efficacy
Timepoint
10 days before and 10 days after the three-month period of interventions
Method of measurement
Using Fall Efficacy ScaleInternational (FES-I) questionnaire
Intervention groups
1
Description
First intervention group (training group):three sessions a week For three months, doTai Chi exercises(sun style) under the supervision of a physician and researcher
Category
Prevention
2
Description
Intervention group 2: Intervention group 1: this group consume Glucosamine Sulfate Supplement three times a week for three months, (Health Burst, American Drug) under supervision Dr. Seyed Hassan Niknejad Hasani has a medical system number 107,821 with a physiotherapy and rehabilitation medicine board.
Category
Prevention
3
Description
Control group: Control group: The control group did not receive any variables , Tai Chi and glucosamine supplementation during the three-month study period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin Islamic Azad University
Full name of responsible person
Elham Attari
Street address
Qazvin Branch, Islamic Azad University, Nokhbegan Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
1519534199
Phone
+98 28 3366 5275
Email
elhamattari58@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research administration of Tehran university (Alborz campus)
Full name of responsible person
Shahin Rafiee
Street address
No.2, Enghelab Ave., Vesal Shirazi Street, Tehran
City
Tehran
Province
Tehran
Postal code
۳۴۱۶۶۱۶۱۶۱
Phone
+98 28 3324 8863
Email
elhamattari58@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research administration of Tehran university (Alborz campus)
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
Alborz Campus of Tehran University
Full name of responsible person
Elham Attari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Physical education, The field of motor behavior
Street address
No.33, Shahed Blvd, Vali asr Ave, , Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3416616161
Phone
+98 28 3324 8863
Email
elhamattari58@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz Campus University of Tehran
Full name of responsible person
Elham attari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physical education is the trend of development and learning of movement
Street address
No33, shahed Ave, valiasr intersection, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3416616161
Phone
+98 28 3324 8863
Email
elhamattari58@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz Campus University of Tehran
Full name of responsible person
Elham Attari
Position
PHD student
Latest degree
Master
Other areas of specialty/work
physical education the field of motor behaviour
Street address
No.33, Shahed ave, Vali Asr intersection, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3416616161
Phone
+98 28 3324 8863
Email
elhamattari58@yahoo.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Information for each person is announced for himself, But for the general public, the overall results are announced. If their personal information is required, their names will not be identified.
When the data will become available and for how long
After the end of the research and publication of the article , will allow access to personal information with each person's code.
To whom data/document is available
The information available to the researcher and people at the centers of science will be available and unclear the name of people.
Under which criteria data/document could be used
For publication of the article, if requested by the scientific center, information will be provided without mentioning the the name of persons
From where data/document is obtainable
The main investigator is
Elham attari,00989122815641,elhamattari58@yahoo.com
Supervisor: Dr. Elaheh Arab Ameri,00989121504509
What processes are involved for a request to access data/document
Call the phone or send an email to the original researcher