Comparing the effectiveness of a home-based exercise program via the mobile application (Varzeshyar) and a routine home-based exercise program on pain and disability of knee osteoarthritis in patients at ages older than 55
Mobile application development with animation learning exercise training
Effectiveness of a home-based exercise program via the mobile application on pain and disability of knee osteoarthritis
Design
Required application will be developed at first then 100 patients older than 55 years with knee osteoarthritis will be selected and based on computer randomization put in 2 groups: intervention and control.
Intervention group will receive application on their phones and control group from pamphlet.
Settings and conduct
The patients with knee osteoarthritis who referred to clinic of rheumatology in Rasoole Akram hospital from 3 March 2018 to 22 October 2018 will be examined. after take demographic information they will be divided in 2 groups: intervention and control.
exercise protocol contains 10 movement for lower limb(strengthening and stretching).
According to allowed movements for each person a home-based exercise training will be developed and progressively will complete in 4 weeks and will continue for 8 weeks for maintenance therapy.
Participants/Inclusion and exclusion criteria
Entry:
The patients who suffer from primary knee osteoarthritis that according to Kellgren and Lawrence classification have grade 2 to 4 severity of disease and have osteoarthritis based on A.C.R criteria
No entry:
Inability to use of mobile application and smart phone
Limitation in strengthening exercise
Age less than 50 years
Intervention groups
Home_ based exercise with mobile application: The impact of home based exercise with mobile application on pain, disability and quality of life in patients with knee osteoarthritis.
Home_ based exercise with pamphlet: The impact of home based exercise with pamphlet on pain, disability and quality of life in patients with knee osteoarthritis.
Main outcome variables
pain; Quality of life ; Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190116042386N1
Registration date:2019-02-12, 1397/11/23
Registration timing:retrospective
Last update:2019-02-12, 1397/11/23
Update count:0
Registration date
2019-02-12, 1397/11/23
Registrant information
Name
Zohre Abbaszade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6657 4251
Email address
kianmehr.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-03, 1396/12/12
Expected recruitment end date
2018-10-04, 1397/07/12
Actual recruitment start date
2018-03-03, 1396/12/12
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2019-01-20, 1397/10/30
Scientific title
Comparing the effectiveness of a home-based exercise program via the mobile application (Varzeshyar) and a routine home-based exercise program on pain and disability of knee osteoarthritis in patients at ages older than 55
Public title
Effectiveness of a home-based exercise program via the mobile application (Varzeshyar) on pain and disability of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who suffer from primary knee osteoarthritis that according to Kellgren and Lawrence classification have grade 2 to 4 severity of disease and have osteoarthritis based on ACR criteria
Exclusion criteria:
Age less than 50 years
Limitation in strengthening exercise
Inability to use of mobile application and smart phone
Age
From 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
135
Randomization (investigator's opinion)
Randomized
Randomization description
Computer randomization based on file number
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 of Iran University of Medical Sciences
Street address
No. 270-3, Golshan Ave., Jomhouri Blvd.
City
Tehran
Province
Tehran
Postal code
1313634519
Approval date
2017-11-28, 1396/09/07
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411497003/
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Disability score in WOMAC questionnaire
Timepoint
WOMAC questionnaire score at start of study, week 4, week 12
Method of measurement
WOMAC questionnaire
2
Description
Symptoms severity score in Lequesne questionnaire
Timepoint
Lequesne questionnaire score at start of study, week 4, week 12
Method of measurement
Lequesne questionnaire
3
Description
Quality of life score in SF8 questionnaire
Timepoint
SF8 questionnaire score at start of study, week 4, week 12
Method of measurement
SF8 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Home_ based exercise training with mobile application
Category
Treatment - Other
2
Description
Control group: Home_ based exercise training with pamphlet
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zohre Abbaszade
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
No 270-3 , Jomhory Ave, Golshan Shoomali
City
Tehran
Province
Tehran
Postal code
1313634519
Phone
+98 21 6657 4251
Fax
Email
kianmehr.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zohre Abbaszade
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
No 270-3 , Jomhory Ave, Golshan Shoomali
City
Tehran
Province
Tehran
Postal code
1313634519
Phone
+98 21 6657 4251
Fax
Email
kianmehr.n@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zohre Abbaszade
Position
Medical resident
Latest degree
Specialist
Other areas of specialty/work
Geriatrics
Street address
No 270-3 , Jomhory Ave, Golshan Shoomali
City
Tehran
Province
Tehran
Postal code
1313634519
Phone
+98 21 6657 4251
Fax
Email
kianmehr.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no additional information.
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study protocol: The entire study protocol is shareable.
Statistical Analysis Map: The entire statistical analysis map is shareable.
clinical study report: The entire clinical study report is shareable.
Data categorization system: The Data categorization system is shareable.
When the data will become available and for how long
Start the access period 2 months after printing results
To whom data/document is available
Researchers working in Academic Institutions
Under which criteria data/document could be used
For any kind of research in the field of medicine is possible.
From where data/document is obtainable
Dr Zohre Abbaszade
09132383725
zanasim88@gmail.com
What processes are involved for a request to access data/document
After sending the request by email within 2 weeks, the documentation is sent by email.