Protocol summary
-
Study aim
-
Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
-
Design
-
Due to the importance of homogenization of the two groups of control and intervention, a randomized randomization method is used in which elimination of possible heterogeneity by classification is performed on the variables of the disease grade prior to random allocation. A clinical trial Blind two-way, calculation of sample size based on the formula and by conducting pilot studies.
-
Settings and conduct
-
Initial and pre-test measurements in the physiotherapy center of Imam Ali Hospital in Bojnourd, provide training and advice on how to conduct resistance exercises correctly through the application within 2 months randomly and without knowledge of the participants and evaluators. Patients will be treated.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:Satisfaction to do research،Radiological signs of knee osteoarthritis with the approval of a physician،Age 40-70 years،The patient and patient accompanying the smartphone should be available،Have the ability to use the mobile app،Exclusion criteria:Patients who have to undergo a knee surgery during the study،Use intra-articular intravenous medications during the study،During the study, they will develop mental illness،Underlying illness (such as diabetes, ...)،They are reluctant to continue to participate in the study
-
Intervention groups
-
Intervention group:Patients with knee osteoarthritis who receive the application will receive training and advice for the correct performance of the exercise through the app within 2 months.Control group:Patients with knee osteoarthritis who, according to the routine, are trained and advised to improve their quality of life.
-
Main outcome variables
-
Knee pain in women with knee osteoarthritis
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20161208031300N2
Registration date:
2019-04-06, 1398/01/17
Registration timing:
registered_while_recruiting
Last update:
2019-05-18, 1398/02/28
Update count:
1
-
Registration date
-
2019-04-06, 1398/01/17
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-03-21, 1398/01/01
-
Expected recruitment end date
-
2019-04-09, 1398/01/20
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
-
Public title
-
Reviews of the effectiveness of the learning-based mobile application (mobile app) to improve physical function of patients with osteoarthritis of the knee ladies
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Satisfaction to do research
Radiological symptoms of knee osteoarthritis with the approval of a physician
The age range is between 40-70 years
The smartphone itself is the patient or companion patient that is always available to the patient
Ability to use the mobile app
Exclusion criteria:
Patients who undergo surgery on their knees.
use intra-articular injectable drugs
they will develop mental illness
Underlying illness (such as diabetes, ...)
Failure to follow up
-
Age
-
From 40 years old to 70 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
64
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
A random assignment sequence has been created, each row of sequences placed inside a pre-waxed envelope, and then the envelopes are arranged in the box, and the patients removed one of the envelopes and then opened the envelope scholar. And doing the study according to the group in which the person is located.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
To blind, a researcher who collects information about the performance and quality of life of patients, is not aware of the presence of any patient in the intervention group or group comparison.Also, in order to prevent the patients from moving between groups, after the patients were randomly assigned to the intervention and intervention group, they will be asked to request intervention from the patients in the couple's days and the patients in the comparison group on the following days. The clinic is to prevent patients from speaking in groups.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-01-15, 1397/10/25
-
Ethics committee reference number
-
ir.nkums.rec.1397.085
Health conditions studied
1
-
Description of health condition studied
-
Knee Osteoarthritis
-
ICD-10 code
-
M17.0
-
ICD-10 code description
-
Primary gonarthrosis, bilateral
Primary outcomes
1
-
Description
-
Knee pain
-
Timepoint
-
24 hours before the intervention and 24 hours after the intervention
-
Method of measurement
-
Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes
1
-
Description
-
improving the quality of life
-
Timepoint
-
24 hours before the intervention and 24 hours after the intervention
-
Method of measurement
-
Health Assessment Questionnaire
Intervention groups
1
-
Description
-
Intervention group:Patients with knee osteoarthritis who receive the application will receive training and advice for the correct performance of the exercise through the app within 2 months.
-
Category
-
Treatment - Devices
2
-
Description
-
Control group:Patients with knee osteoarthritis who, according to the routine, are trained and advised to improve their quality of life.
-
Category
-
Lifestyle
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Bojnourd 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is 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
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is 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
-
Information about the main outcome of this study will be shared through the article.
-
When the data will become available and for how long
-
The start of the access period will be 6 month after the results are printed.
-
To whom data/document is available
-
For researchers working in academic and scientific institutions and those engaged in the industry, they can apply for them.
-
Under which criteria data/document could be used
-
Terms of use of data or documentation: 1. Failure to remove or modify the original address of the authors of scientific articles 2. Present actual research results 3. Having specialized knowledge and academic competence in the research subject 4. Observe the interests of stakeholders at all stages 5. No publication of the results of the plan without coordination and obtaining a license
-
From where data/document is obtainable
-
1. dr reza ganji r.ganji@nkums.ac.ir
2. dr hamid reza mohaddes hakak mohaddes76@gmail.com
3. dr hasan saadati Hasansaadati1391@gmail.com
-
What processes are involved for a request to access data/document
-
Applicants will be examined for their evidence and confirmation of their academic and scientific evidence, and will provide the files to them.
-
Comments
-